01 1CSBio
01 1TRIPTORELIN ACETATE, NON- STERILE, BULK DRUG SUBSTANCE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26391
Submission : 2012-09-05
Status : Active
Type : II
47
PharmaCompass offers a list of Triptorelin Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Triptorelin Acetate manufacturer or Triptorelin Acetate supplier for your needs.
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PharmaCompass also assists you with knowing the Triptorelin Acetate API Price utilized in the formulation of products. Triptorelin Acetate API Price is not always fixed or binding as the Triptorelin Acetate Price is obtained through a variety of data sources. The Triptorelin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BIM 21003C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BIM 21003C, including repackagers and relabelers. The FDA regulates BIM 21003C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BIM 21003C API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A BIM 21003C supplier is an individual or a company that provides BIM 21003C active pharmaceutical ingredient (API) or BIM 21003C finished formulations upon request. The BIM 21003C suppliers may include BIM 21003C API manufacturers, exporters, distributors and traders.
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A BIM 21003C DMF (Drug Master File) is a document detailing the whole manufacturing process of BIM 21003C active pharmaceutical ingredient (API) in detail. Different forms of BIM 21003C DMFs exist exist since differing nations have different regulations, such as BIM 21003C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BIM 21003C DMF submitted to regulatory agencies in the US is known as a USDMF. BIM 21003C USDMF includes data on BIM 21003C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BIM 21003C USDMF is kept confidential to protect the manufacturer’s intellectual property.
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