01 1Gyma Laboratories of America
01 1CHLORPHENTERMINE HCL
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2143
Submission : 1973-08-21
Status : Inactive
Type : II
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A Apsedon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apsedon, including repackagers and relabelers. The FDA regulates Apsedon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apsedon 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 Apsedon supplier is an individual or a company that provides Apsedon active pharmaceutical ingredient (API) or Apsedon finished formulations upon request. The Apsedon suppliers may include Apsedon API manufacturers, exporters, distributors and traders.
click here to find a list of Apsedon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Apsedon DMF (Drug Master File) is a document detailing the whole manufacturing process of Apsedon active pharmaceutical ingredient (API) in detail. Different forms of Apsedon DMFs exist exist since differing nations have different regulations, such as Apsedon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apsedon DMF submitted to regulatory agencies in the US is known as a USDMF. Apsedon USDMF includes data on Apsedon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apsedon USDMF is kept confidential to protect the manufacturer’s intellectual property.
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