Ensuring you have access to all the information you need, find here comprehensive documentation related to Regulatory compliance and Quality assurance, and Marketing materials.
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
FARMAL® SSG P EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
FARMAL® SSG C EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
MANNITAB™ F1 EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
MANNITAB™ F2 EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
FARMAL® MN5000 EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® GA EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® GA P100 EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
PURITY® 21A EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
PURITY® 21T EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® F5 EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® FN EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® F EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® FL EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® WG220 (China) EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
UNI-PURE® WG220 (India) EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
ULTRA-TEX® 4 EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
FARMAL® SCMC EIP Index
Shows all documentation available on EIP (Excipient Information Package), which ones are public and on demand
FARMAL® SCMC Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® SCMC Specimen CoA IP
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® MN5000 Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® CCS Specimen CoA IP
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® CCS Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® MGS Specimen CoA IP
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® MGS Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® SSG C Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® SSG P Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® SSG P Specimen CoA IP
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ F2 Export Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ F2 Domestic Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ F1 Export Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ F1 Domestic Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ SD1 Export Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ SD1 Domestic Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
PURITY® 21T Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
PURITY® 21A Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
UNI-PURE® FN Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
UNI-PURE® F5 Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
UNI-PURE® GA P100 Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
UNI-PURE® GA Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
ULTRA-TEX® 4 Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
FARMAL® SCMC Release Specification
Shows the quality standards of a material according to a list of tests required
FARMAL® SCMC Release Specification
Shows the quality standards of a material according to a list of tests required
FARMAL® MN5000 Release Specification
Shows the quality standards of a material according to a list of tests required
FARMAL® CCS Release Specification IP
Shows the quality standards of a material according to a list of tests required
FARMAL® CCS Release Specification
Shows the quality standards of a material according to a list of tests required
FARMAL® MGS Release Specification
Shows the quality standards of a material according to a list of tests required
FARMAL® MGS Release Specification IP
Shows the quality standards of a material according to a list of tests required
FARMAL® SSG C Release Specification
Shows the quality standards of a material according to a list of tests required
FARMAL® SSG P Release Specification IP
Shows the quality standards of a material according to a list of tests required
FARMAL® SSG P Release Specification
Shows the quality standards of a material according to a list of tests required
MANNITAB™ F2 Release Specification
Shows the quality standards of a material according to a list of tests required
MANNITAB™ F1 Release Specification
Shows the quality standards of a material according to a list of tests required
MANNITAB™ SD1 Release Specification
Shows the quality standards of a material according to a list of tests required
PURITY® 21T Release Specification
Shows the quality standards of a material according to a list of tests required
PURITY® 21A Release Specification
Shows the quality standards of a material according to a list of tests required
UNI-PURE® FN Release Specification
Shows the quality standards of a material according to a list of tests required
UNI-PURE® F5 Release Specification
Shows the quality standards of a material according to a list of tests required
UNI-PURE® GA P100 Release Specification
Shows the quality standards of a material according to a list of tests required
UNI-PURE® GA Release Specification
Shows the quality standards of a material according to a list of tests required
UNI-PURE® FL Release Specification
Shows the quality standards of a material according to a list of tests required
MANNITAB™ SD2 Release Specification
Shows the quality standards of a material according to a list of tests required
ULTRA-TEX® 4 Release Specification
Shows the quality standards of a material according to a list of tests required
FARMAL® SCMC MSDS
MSDS: Material Safety Data Sheet
FARMAL® MN5000 MSDS
MSDS: Material Safety Data Sheet
FARMAL® CCS MSDS
MSDS: Material Safety Data Sheet
FARMAL® MGS MSDS
MSDS: Material Safety Data Sheet
FARMAL® SSG C MSDS
MSDS: Material Safety Data Sheet
FARMAL® SSG P MSDS
MSDS: Material Safety Data Sheet
MANNITAB™ F2 MSDS
MSDS: Material Safety Data Sheet
MANNITAB™ F1 MSDS
MSDS: Material Safety Data Sheet
MANNITAB™ SD1 MSDS
MSDS: Material Safety Data Sheet
PURITY® 21T MSDS
MSDS: Material Safety Data Sheet
PURITY® 21A MSDS
MSDS: Material Safety Data Sheet
UNI-PURE® FN MSDS
MSDS: Material Safety Data Sheet
UNI-PURE® F5 MSDS
MSDS: Material Safety Data Sheet
UNI-PURE® GA P100 MSDS
MSDS: Material Safety Data Sheet
UNI-PURE® GA MSDS
MSDS: Material Safety Data Sheet
UNI-PURE® FL MSDS
MSDS: Material Safety Data Sheet
MANNITAB™ SD2 MSDS
MSDS: Material Safety Data Sheet
ULTRA-TEX® 4 MSDS
MSDS: Material Safety Data Sheet
FARMAL® SCMC Label
Displays the label graphic
FARMAL® MN5000 Label
Displays the label graphic
FARMAL® CCS Label
Displays the label graphic
FARMAL® MGS Label
Displays the label graphic
FARMAL® SSG C Label
Displays the label graphic
FARMAL® SSG P Label
Displays the label graphic
PURITY® 21T Label
Displays the label graphic
PURITY® 21A Label
Displays the label graphic
UNI-PURE® FN Label
Displays the label graphic
UNI-PURE® F5 Label
Displays the label graphic
UNI-PURE® GA P100 Label
Displays the label graphic
UNI-PURE® GA Label
Displays the label graphic
UNI-PURE® FL Label
Displays the label graphic
ULTRA-TEX® 4 Label
Displays the label graphic
FARMAL® SCMC TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
FARMAL® MN5000 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
FARMAL® CCS TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
FARMAL® MGS TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
FARMAL® SSG C TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
FARMAL® SSG P TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
MANNITAB™ F2 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
MANNITAB™ F1 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
MANNITAB™ SD1 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
PURITY® 21T TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
PURITY® 21A TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
UNI-PURE® FN TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
UNI-PURE® F5 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
UNI-PURE® GA P100 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
UNI-PURE® GA TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
UNI-PURE® FL TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
MANNITAB™ SD2 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
ULTRA-TEX® 4 TSE BSE
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy)
FARMAL® SCMC Source of origin
The country of origin of the excipient
FARMAL® MN5000 Source of origin
The country of origin of the excipient
FARMAL® CCS Source of origin
The country of origin of the excipient
FARMAL® MGS Source of origin
The country of origin of the excipient
FARMAL® SSG C Source of origin
The country of origin of the excipient
FARMAL® SSG P Source of orgin
The country of origin of the excipient
MANNITAB™ F2 Source of origin
The country of origin of the excipient
MANNITAB™ F1 Source of origin
The country of origin of the excipient
MANNITAB™ SD1 Source of origin
The country of origin of the excipient
PURITY® 21T Source of origin
The country of origin of the excipient
PURITY® 21A Source of origin
The country of origin of the excipient
UNI-PURE® FN Source of origin
The country of origin of the excipient
UNI-PURE® F5 Source of origin
The country of origin of the excipient
UNI-PURE® GA P100 Source of origin
The country of origin of the excipient
UNI-PURE® GA Source of origin
The country of origin of the excipient
UNI-PURE® FL Source of origin
The country of origin of the excipient
MANNITAB™ SD2 Source of origin
The country of origin of the excipient
ULTRA-TEX® 4 Source of origin
The country of origin of the excipient
FARMAL® SCMC Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
FARMAL® MN5000 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
FARMAL® CCS Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
FARMAL® MGS Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
FARMAL® SSG C Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
FARMAL® SSG P Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
MANNITAB™ F2 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
MANNITAB™ F1 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
MANNITAB™ SD1 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
PURITY® 21T Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
PURITY® 21A Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
UNI-PURE® FN Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
UNI-PURE® F5 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
UNI-PURE® GA P100 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
UNI-PURE® GA Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
UNI-PURE® FL Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
MANNITAB™ SD2 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
ULTRA-TEX® 4 Regulatory Compliance
Compendial compliance (for example, USP-NF, Ph. Eur or BP, JP, JPE) and other regulatory status
FARMAL® SCMC Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
FARMAL® MN5000 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
FARMAL® CCS Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
FARMAL® MGS Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
FARMAL® SSG C Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
FARMAL® SSG P Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
MANNITAB™ F2 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
MANNITAB™ F1 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
MANNITAB™ SD1 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
PURITY® 21T Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
PURITY® 21A Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
UNI-PURE® FN Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
UNI-PURE® F5 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
UNI-PURE® GA P100 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
UNI-PURE® GA Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
UNI-PURE® FL Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
MANNITAB™ SD2 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
ULTRA-TEX® 4 Non-GMO
A declaration that the material is not derived from a Genetically Modified Organism (GMO)
FARMAL® SCMC Heavy metal
Reports the detection and estimation of the Heavy Metals
FARMAL® MN5000 Heavy metal
Reports the detection and estimation of the Heavy Metals
FARMAL® CCS Heavy metal
Reports the detection and estimation of the Heavy Metals
FARMAL® MGS Heavy metal
Reports the detection and estimation of the Heavy Metals
FARMAL® SSG C Heavy metal
Reports the detection and estimation of the Heavy Metals
FARMAL® SSG P Heavy metal
Reports the detection and estimation of the Heavy Metals
MANNITAB™ F2 Heavy metal
Reports the detection and estimation of the Heavy Metals
MANNITAB™ F1 Heavy metal
Reports the detection and estimation of the Heavy Metals
MANNITAB™ SD1 Heavy metal
Reports the detection and estimation of the Heavy Metals
PURITY® 21T Heavy metal
Reports the detection and estimation of the Heavy Metals
PURITY® 21A Heavy metal
Reports the detection and estimation of the Heavy Metals
UNI-PURE® FN Heavy metal
Reports the detection and estimation of the Heavy Metals
UNI-PURE® F5 Heavy metal
Reports the detection and estimation of the Heavy Metals
UNI-PURE® GA P100 Heavy metal
Reports the detection and estimation of the Heavy Metals
UNI-PURE® GA Heavy metal
Reports the detection and estimation of the Heavy Metals
UNI-PURE® FL Heavy metal
Reports the detection and estimation of the Heavy Metals
MANNITAB™ SD2 Heavy metal
Reports the detection and estimation of the Heavy Metals
ULTRA-TEX® 4 Heavy metal
Reports the detection and estimation of the Heavy Metals
FARMAL® SCMC Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
FARMAL® MN5000 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
FARMAL® CCS Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
FARMAL® MGS Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
FARMAL® SSG C Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
FARMAL® SSG P Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
MANNITAB™ F2 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
MANNITAB™ F1 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
MANNITAB™ SD1 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
PURITY® 21T Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
PURITY® 21A Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
UNI-PURE® FN Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
UNI-PURE® F5 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
UNI-PURE® GA P100 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
UNI-PURE® GA Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
UNI-PURE® FL Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
MANNITAB™ SD2 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
ULTRA-TEX® 4 Elemental impurities
Shows the evaluation for elemental impurities and if the excipient complies with the limits specified in ICH Q3D
FARMAL® SCMC Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
FARMAL® CCS Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
FARMAL® MGS Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
FARMAL® SSG C Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
FARMAL® SSG P Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
MANNITAB™ F2 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
MANNITAB™ F1 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
MANNITAB™ SD1 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
FARMAL® MN 5000 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
PURITY® 21T Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
PURITY® 21A Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
UNI-PURE® FN Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
UNI-PURE® F5 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
UNI-PURE® GA P100 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
UNI-PURE® GA Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
UNI-PURE® FL Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
MANNITAB™ SD2 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
ULTRA-TEX® 4 Nitrosamine
A risk assessment to ensure that there is no contamination of Nitrosamine and related compounds in the material
FARMAL® SCMC Allergen
Related to Regulation or specific allergens evaluated
FARMAL® MN5000 Allergen
Related to Regulation or specific allergens evaluated
FARMAL® CCS Allergen
Related to Regulation or specific allergens evaluated
FARMAL® MGS Allergen
Related to Regulation or specific allergens evaluated
FARMAL® SSG C Allergen
Related to Regulation or specific allergens evaluated
FARMAL® SSG P Allergen
Related to Regulation or specific allergens evaluated
MANNITAB™ F2 Allergen
Related to Regulation or specific allergens evaluated
MANNITAB™ F1 Allergen
Related to Regulation or specific allergens evaluated
MANNITAB™ SD1 Allergen
Related to Regulation or specific allergens evaluated
PURITY® 21T Allergen
Related to Regulation or specific allergens evaluated
PURITY® 21A Allergen
Related to Regulation or specific allergens evaluated
UNI-PURE® FN Allergen
Related to Regulation or specific allergens evaluated
UNI-PURE® F5 Allergen
Related to Regulation or specific allergens evaluated
UNI-PURE® GA P100 Allergen
Related to Regulation or specific allergens evaluated
UNI-PURE® GA Allergen
Related to Regulation or specific allergens evaluated
UNI-PURE® FL Allergen
Related to Regulation or specific allergens evaluated
MANNITAB™ SD2 Allergen
Related to Regulation or specific allergens evaluated
ULTRA-TEX® 4 Allergen
Related to Regulation or specific allergens evaluated
FARMAL® SCMC Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
FARMAL® MN5000 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
FARMAL® CCS Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
FARMAL® MGS Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
FARMAL® SSG C Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
FARMAL® SSG P Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
MANNITAB™ F2 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
MANNITAB™ F1 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
MANNITAB™ SD1 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
PURITY® 21T Gluten-free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
PURITY® 21A Gluten-free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
UNI-PURE® FN Gluten-free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
UNI-PURE® F5 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
UNI-PURE® GA P100 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
UNI-PURE® GA Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
UNI-PURE® FL Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
MANNITAB™ SD2 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
ULTRA-TEX® 4 Gluten free
The statement “Gluten-free” applies only if the gluten content in the medicinal product is less than 20 parts per million (ppm)
FARMAL® SCMC Micro analytical
Report which shows Microbial limit test results
FARMAL® MN5000 Microanalytical
Report which shows Microbial limit test results
FARMAL® CCS Micro Analytical
Report which shows Microbial limit test results
FARMAL® MGS Microanalytical
Report which shows Microbial limit test results
FARMAL® SSG C Microanalytical
Report which shows Microbial limit test results
FARMAL® SSG P Microanalytical
Report which shows Microbial limit test results
MANNITAB™ F2 Microanalytical
Report which shows Microbial limit test results
MANNITAB™ F1 Microanalytical
Report which shows Microbial limit test results
MANNITAB™ SD1 Microanalytical
Report which shows Microbial limit test results
UNI-PURE® FL Microanalytical
Report which shows Microbial limit test results
PURITY® 21T Microanalytical
Report which shows Microbial limit test results
PURITY® 21A Microanalytical
Report which shows Microbial limit test results
UNI-PURE® FN Microanalytical
Report which shows Microbial limit test results
UNI-PURE® F5 Microanalytical
Report which shows Microbial limit test results
UNI-PURE® GA P100 Microanalytical
Report which shows Microbial limit test results
UNI-PURE® GA Microanalytical
Report which shows Microbial limit test results
MANNITAB™ SD2 Microanalytical
Report which shows Microbial limit test results
FARMAL® SCMC Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
FARMAL® MN5000 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
FARMAL® CCS Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
FARMAL® MGS Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
FARMAL® SSG C Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
FARMAL® SSG P Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
MANNITAB™ F2 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
MANNITAB™ F1 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
MANNITAB™ SD1 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
PURITY® 21T Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
PURITY® 21A Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
UNI-PURE® FN Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
UNI-PURE® F5 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
UNI-PURE® GA P100 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
UNI-PURE® GA Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
UNI-PURE® FL Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
MANNITAB™ SD2 Export Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ SD2 Domestic Specimen CoA
Certifies the quality of the excipient and demonstrates the batch meets the defined specification
MANNITAB™ SD2 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
ULTRA-TEX® 4 Residual solvent
Declares that the levels of residual solvents in the material meets the limits defined by the pharmacopeia
FARMAL® SCMC GRAS
GRAS: Generally Recognized as Safe
FARMAL® MN5000 GRAS
GRAS: Generally Recognized as Safe
FARMAL® CCS GRAS
GRAS: Generally Recognized as Safe
FARMAL® MGS GRAS
GRAS: Generally Recognized as Safe
FARMAL® SSG C GRAS
GRAS: Generally Recognized as Safe
FARMAL® SSG P GRAS
GRAS: Generally Recognized as Safe
MANNITAB™ F2 GRAS
GRAS: Generally Recognized as Safe
MANNITAB™ F1 GRAS
GRAS: Generally Recognized as Safe
MANNITAB™ SD1 GRAS
GRAS: Generally Recognized as Safe
PURITY® 21T GRAS
GRAS: Generally Recognized as Safe
PURITY® 21A GRAS
GRAS: Generally Recognized as Safe
UNI-PURE® FN GRAS
GRAS: Generally Recognized as Safe
UNI-PURE® F5 GRAS
GRAS: Generally Recognized as Safe
UNI-PURE® GA P100 GRAS
GRAS: Generally Recognized as Safe
UNI-PURE® GA GRAS
GRAS: Generally Recognized as Safe
UNI-PURE® FL GRAS
GRAS: Generally Recognized as Safe
MANNITAB™ SD2 GRAS
"GRAS" is an acronym for Generally Recognized As Safe
ULTRA-TEX® 4 GRAS
GRAS: Generally Recognized as Safe
FARMAL® SCMC Storage conditions
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
FARMAL® MN5000 Storage conditions
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
FARMAL® CCS Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
FARMAL® MGS Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
FARMAL® SSG C Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
FARMAL® SSG P Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
MANNITAB™ F2 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
MANNITAB™ F1 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
MANNITAB™ SD1 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
PURITY® 21T Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
PURITY® 21A Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
UNI-PURE® FN Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
UNI-PURE® F5 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
UNI-PURE® GA P100 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
UNI-PURE® GA Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
UNI-PURE® FL Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
MANNITAB™ SD2 Storage condition
The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies
FARMAL® SCMC Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
FARMAL® MN5000 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
FARMAL® CCS Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
FARMAL® MGS Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
FARMAL® SSG C Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
FARMAL® SSG P Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
MANNITAB™ F2 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
MANNITAB™ F1 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
MANNITAB™ SD1 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
PURITY® 21T Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
PURITY® 21A Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
UNI-PURE® FN Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
UNI-PURE® F5 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
UNI-PURE® GA P100 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
UNI-PURE® GA Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
UNI-PURE® FL Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
MANNITAB™ SD2 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
ULTRA-TEX® 4 Latex free
Certifies that the material is not made with natural rubber latex, latex derivatives
FARMAL® SCMC Genotoxic
Declaration if the material is free from Genotoxic Impurities
FARMAL® MN5000 Genotoxic
Declaration if the material is free from Genotoxic Impurities
FARMAL® CCS Genotoxic
Declaration if the material is free from Genotoxic Impurities
FARMAL® MGS Genotoxic
Declaration if the material is free from Genotoxic Impurities
FARMAL® SSG C Genotoxic
Declaration if the material is free from Genotoxic Impurities
FARMAL® SSG P Genotoxic
Declaration if the material is free from Genotoxic Impurities
MANNITAB™ F2 Genotoxic
Declaration if the material is free from Genotoxic Impurities
MANNITAB™ F1 Genotoxic
Declaration if the material is free from Genotoxic Impurities
MANNITAB™ SD1 Genotoxic
Declaration if the material is free from Genotoxic Impurities
PURITY® 21T Genotoxic
Declaration if the material is free from Genotoxic Impurities
PURITY® 21A Genotoxic
Declaration if the material is free from Genotoxic Impurities
UNI-PURE® FN Genotoxic
Declaration if the material is free from Genotoxic Impurities
UNI-PURE® F5 Genotoxic free
Declaration if the material is free from Genotoxic Impurities
UNI-PURE® GA P100 Genotoxic free
Declaration if the material is free from Genotoxic Impurities
UNI-PURE® GA Genotoxic free
Declaration if the material is free from Genotoxic Impurities
UNI-PURE® FL Genotoxic free
Declaration if the material is free from Genotoxic Impurities
MANNITAB™ SD2 Genotoxic free
Declaration if the material is free from Genotoxic Impurities
ULTRA-TEX® 4 Genotoxic free
Declaration if the material is free from Genotoxic Impurities
FARMAL® SCMC Viral microbiological
Viral safety information
FARMAL® MN5000 Viral microbiological
Viral safety information
FARMAL® CCS Viral microbiological
Viral safety information
FARMAL® MGS Viral microbiological
Viral safety information
FARMAL® SSG C Viral microbiological
Viral safety information
FARMAL® SSG P Viral microbiological
Viral safety information
MANNITAB™ F2 Viral microbiological
Viral safety information
MANNITAB™ F1 Viral microbiological
Viral safety information
MANNITAB™ SD1 Viral microbiological
Viral safety information
PURITY® 21T Viral microbiological
Viral safety information
PURITY® 21A Viral microbiological
Viral safety information
UNI-PURE® FN Viral microbiological
Viral safety information
UNI-PURE® F5 Viral microbiological
Viral safety information
UNI-PURE® GA P100 Viral microbiological
Viral safety information
UNI-PURE® GA Viral microbiological
Viral safety information
UNI-PURE® FL Viral microbiological
Viral safety information
MANNITAB™ SD2 Viral microbiological
Declaration that the material is free from viral and microbiological contamination
ULTRA-TEX® 4 Viral microbiological
Viral safety information
FARMAL® SCMC Melamine
Declaration that confirm if the material is free of melamine contamination
FARMAL® MN5000 Melamine
Declaration that confirm if the material is free of melamine contamination
FARMAL® CCS Melamine
Declaration that confirm if the material is free of melamine contamination
FARMAL® MGS Melamine
Declaration that confirm if the material is free of melamine contamination
FARMAL® SSG C Melamine
Declaration that confirm if the material is free of melamine contamination
FARMAL® SSG P Melamine
Declaration that confirm if the material is free of melamine contamination
MANNITAB™ F2 Melamine
Declaration that confirm if the material is free of melamine contamination
MANNITAB™ F1 Melamine
Declaration that confirm if the material is free of melamine contamination
MANNITAB™ SD1 Melamine
Declaration that confirm if the material is free of melamine contamination
PURITY® 21T Melamine
Declaration that confirm if the material is free of melamine contamination
PURITY® 21A Melamine
Declaration that confirm if the material is free of melamine contamination
UNI-PURE® FN Melamine
Declaration that confirm if the material is free of melamine contamination
UNI-PURE® F5 Melamine
Declaration that confirm if the material is free of melamine contamination
UNI-PURE® GA P100 Melamine
Declaration that confirm if the material is free of melamine contamination
UNI-PURE®GA Melamine
Declaration that confirm if the material is free of melamine contamination
UNI-PURE® FL Melamine
Declaration that confirm if the material is free of melamine contamination
MANNITAB™ SD2 Melamine
Declaration that confirm if the material is free of melamine contamination
ULTRA-TEX® 4 Melamine
Declaration that confirm if the material is free of melamine contamination
FARMAL® SCMC Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
FARMAL® MN5000 Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
FARMAL® CCS Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
FARMAL® MGS Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
FARMAL® SSG C Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
FARMAL® SSG P Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
MANNITAB™ F2 Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
MANNITAB™ F1 Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
MANNITAB™ SD1 Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
PURITY® 21T Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
PURITY® 21A Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
UNI-PURE® FN Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
UNI-PURE® F5 Shelf-life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
UNI-PURE® GA P100 Shelf-life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
UNI-PURE® GA Shelf-life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
UNI-PURE® FL Shelf-life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
MANNITAB™ SD2 Shelf life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
ULTRA-TEX® 4 Shelf-life
The duration, normally expressed in months or years from the date of manufacture, throughout which the excipient should continue to conform to the specification.
FARMAL® SCMC Stability IP
To show that the stability meets the excipient specification
FARMAL® SCMC Stability
To show that the stability meets the excipient specification
FARMAL® MN5000 Stability
To show that the stability meets the excipient specification
FARMAL® CCS Stability IP
To show that the stability meets the excipient specification
FARMAL® CCS Stability
To show that the stability meets the excipient specification
FARMAL® MGS Stability
To show that the stability meets the excipient specification
FARMAL® MGS Stability IP
To show that the stability meets the excipient specification
FARMAL® SSG C Stability
To show that the stability meets the excipient specification
FARMAL® SSG C Stability
To show that the stability meets the excipient specification
FARMAL® SSG P Stability IP
To show that the stability meets the excipient specification
FARMAL® SSG P Stability
To show that the stability meets the excipient specification
FARMAL® SSG P Stability IP
To show that the stability meets the excipient specification
MANNITAB™ F2 Stability
To show that the stability meets the excipient specification
MANNITAB™ F1 Stability
To show that the stability meets the excipient specification
MANNITAB™ SD1 Stability
To show that the stability meets the excipient specification
UNI-PURE® FN Stability
To show that the stability meets the excipient specification
UNI-PURE® F5 Stability
To show that the stability meets the excipient specification
UNI-PURE® GA P100 Stability
To show that the stability meets the excipient specification
UNI-PURE® GA Stability
To show that the stability meets the excipient specification
MANNITAB™ SD2 Stability
Defines the stability of the material according to the method which its needs to comply
FARMAL® SCMC Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
FARMAL® SCMC Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
FARMAL® MN5000 Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
FARMAL® CCS Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
FARMAL® CCS Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
FARMAL® MGS Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
FARMAL® MGS Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
FARMAL® SSG C Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
FARMAL® SSG C Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
FARMAL® SSG P Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
FARMAL® SSG P Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
MANNITAB™ F2 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
MANNITAB™ F1 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
MANNITAB™ SD1 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
PURITY® 21T Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
PURITY® 21A Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
PURITY® 21T Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
PURITY® 21A Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
UNI-PURE® FN Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
UNI-PURE® F5 Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
UNI-PURE® F5 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
UNI-PURE® GA P100 Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
UNI-PURE® GA P100 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
UNI-PURE® GA Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
UNI-PURE® GA Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
UNI-PURE® F Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
UNI-PURE® F Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
MANNITAB™ SD2 Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
UNI-PURE® WG220 (China) Kosher
Certifies that this ingredient and the process of preparing it complies with orthodox kosher
UNI-PURE® WG220 (China) Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
UNI-PURE® WG220 (India) Halal
Halal indicates that this product is permitted and fit for consumption according to Islamic law
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