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
A L-Lactic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Lactic Acid, including repackagers and relabelers. The FDA regulates L-Lactic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-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 L-Lactic Acid supplier is an individual or a company that provides L-Lactic Acid active pharmaceutical ingredient (API) or L-Lactic Acid finished formulations upon request. The L-Lactic Acid suppliers may include L-Lactic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of L-Lactic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Lactic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Lactic Acid active pharmaceutical ingredient (API) in detail. Different forms of L-Lactic Acid DMFs exist exist since differing nations have different regulations, such as L-Lactic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Lactic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. L-Lactic Acid USDMF includes data on L-Lactic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Lactic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Lactic Acid suppliers with USDMF on PharmaCompass.
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