Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
01 1Evonik
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01 2L-ORNITHINE L-ASPARTATE
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Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35044
Submission : 2020-08-19
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41004
Submission : 2024-12-23
Status : Active
Type : II
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A L-Ornithine L-aspartate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Ornithine L-aspartate, including repackagers and relabelers. The FDA regulates L-Ornithine L-aspartate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Ornithine L-aspartate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of L-Ornithine L-aspartate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Ornithine L-aspartate supplier is an individual or a company that provides L-Ornithine L-aspartate active pharmaceutical ingredient (API) or L-Ornithine L-aspartate finished formulations upon request. The L-Ornithine L-aspartate suppliers may include L-Ornithine L-aspartate API manufacturers, exporters, distributors and traders.
click here to find a list of L-Ornithine L-aspartate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Ornithine L-aspartate DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Ornithine L-aspartate active pharmaceutical ingredient (API) in detail. Different forms of L-Ornithine L-aspartate DMFs exist exist since differing nations have different regulations, such as L-Ornithine L-aspartate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Ornithine L-aspartate DMF submitted to regulatory agencies in the US is known as a USDMF. L-Ornithine L-aspartate USDMF includes data on L-Ornithine L-aspartate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Ornithine L-aspartate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Ornithine L-aspartate suppliers with USDMF on PharmaCompass.
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