01 1Yifan Pharmaceutical
01 1SOMATROPIN
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41783
Submission : 2025-04-28
Status : Active
Type : II
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A Somatropin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somatropin, including repackagers and relabelers. The FDA regulates Somatropin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somatropin 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 Somatropin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Somatropin supplier is an individual or a company that provides Somatropin active pharmaceutical ingredient (API) or Somatropin finished formulations upon request. The Somatropin suppliers may include Somatropin API manufacturers, exporters, distributors and traders.
click here to find a list of Somatropin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Somatropin DMF (Drug Master File) is a document detailing the whole manufacturing process of Somatropin active pharmaceutical ingredient (API) in detail. Different forms of Somatropin DMFs exist exist since differing nations have different regulations, such as Somatropin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Somatropin DMF submitted to regulatory agencies in the US is known as a USDMF. Somatropin USDMF includes data on Somatropin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Somatropin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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