01 1Corbion
01 1L(+)LACTIC ACID
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-28
Pay. Date : 2022-09-23
DMF Number : 20726
Submission : 2007-07-26
Status : Active
Type : II
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PharmaCompass offers a list of L-Lactic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right L-Lactic Acid manufacturer or L-Lactic Acid supplier for your needs.
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A (S)-()-Lactic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (S)-()-Lactic acid, including repackagers and relabelers. The FDA regulates (S)-()-Lactic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (S)-()-Lactic acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A (S)-()-Lactic acid supplier is an individual or a company that provides (S)-()-Lactic acid active pharmaceutical ingredient (API) or (S)-()-Lactic acid finished formulations upon request. The (S)-()-Lactic acid suppliers may include (S)-()-Lactic acid API manufacturers, exporters, distributors and traders.
click here to find a list of (S)-()-Lactic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A (S)-()-Lactic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (S)-()-Lactic acid active pharmaceutical ingredient (API) in detail. Different forms of (S)-()-Lactic acid DMFs exist exist since differing nations have different regulations, such as (S)-()-Lactic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (S)-()-Lactic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (S)-()-Lactic acid USDMF includes data on (S)-()-Lactic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (S)-()-Lactic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (S)-()-Lactic acid suppliers with USDMF on PharmaCompass.
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