01 1Merck & Co
01 1HYALURONIC ACID LMW
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11593
Submission : 1995-07-20
Status : Inactive
Type : II
19
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A Hyaluronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyaluronic Acid, including repackagers and relabelers. The FDA regulates Hyaluronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyaluronic 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.
click here to find a list of Hyaluronic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hyaluronic Acid supplier is an individual or a company that provides Hyaluronic Acid active pharmaceutical ingredient (API) or Hyaluronic Acid finished formulations upon request. The Hyaluronic Acid suppliers may include Hyaluronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Hyaluronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hyaluronic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyaluronic Acid active pharmaceutical ingredient (API) in detail. Different forms of Hyaluronic Acid DMFs exist exist since differing nations have different regulations, such as Hyaluronic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyaluronic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Hyaluronic Acid USDMF includes data on Hyaluronic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyaluronic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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