01 1Peninsula Laboratories
01 1LEUCINE-ENKEPHALIN
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5790
Submission : 1985-04-18
Status : Inactive
Type : II
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PharmaCompass offers a list of Enkephalin 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 Enkephalin manufacturer or Enkephalin supplier for your needs.
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A Enkephalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enkephalin, including repackagers and relabelers. The FDA regulates Enkephalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enkephalin 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 Enkephalin supplier is an individual or a company that provides Enkephalin active pharmaceutical ingredient (API) or Enkephalin finished formulations upon request. The Enkephalin suppliers may include Enkephalin API manufacturers, exporters, distributors and traders.
click here to find a list of Enkephalin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Enkephalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Enkephalin active pharmaceutical ingredient (API) in detail. Different forms of Enkephalin DMFs exist exist since differing nations have different regulations, such as Enkephalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enkephalin DMF submitted to regulatory agencies in the US is known as a USDMF. Enkephalin USDMF includes data on Enkephalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enkephalin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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