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