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01 1HISTRELIN (LHRH AGONIST) IMPLANTS
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9913
Submission : 1992-09-29
Status : Inactive
Type : II
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PharmaCompass offers a list of Histrelin 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 Histrelin manufacturer or Histrelin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Histrelin manufacturer or Histrelin supplier.
A Histrelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Histrelin, including repackagers and relabelers. The FDA regulates Histrelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Histrelin 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 Histrelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Histrelin supplier is an individual or a company that provides Histrelin active pharmaceutical ingredient (API) or Histrelin finished formulations upon request. The Histrelin suppliers may include Histrelin API manufacturers, exporters, distributors and traders.
click here to find a list of Histrelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Histrelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Histrelin active pharmaceutical ingredient (API) in detail. Different forms of Histrelin DMFs exist exist since differing nations have different regulations, such as Histrelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Histrelin DMF submitted to regulatory agencies in the US is known as a USDMF. Histrelin USDMF includes data on Histrelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Histrelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Histrelin suppliers with USDMF on PharmaCompass.
