Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
01 1Pfizer CentreOne
02 1F.I.S. Fabbrica Italiana Sintetici
03 2Fujifilm Diosynth Biotechnologies
04 1Jiangsu Jiaerke Pharmaceuticals Group
05 2Merck & Co
06 2SIGMA TAU
07 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28729
Submission : 2014-12-11
Status :
Type : II
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PharmaCompass offers a list of Prasterone 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 Prasterone Acetate manufacturer or Prasterone Acetate supplier for your needs.
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PharmaCompass also assists you with knowing the Prasterone Acetate API Price utilized in the formulation of products. Prasterone Acetate API Price is not always fixed or binding as the Prasterone Acetate Price is obtained through a variety of data sources. The Prasterone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prasterone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prasterone Acetate, including repackagers and relabelers. The FDA regulates Prasterone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prasterone Acetate 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 Prasterone Acetate supplier is an individual or a company that provides Prasterone Acetate active pharmaceutical ingredient (API) or Prasterone Acetate finished formulations upon request. The Prasterone Acetate suppliers may include Prasterone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Prasterone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prasterone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prasterone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Prasterone Acetate DMFs exist exist since differing nations have different regulations, such as Prasterone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prasterone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Prasterone Acetate USDMF includes data on Prasterone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prasterone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prasterone Acetate suppliers with USDMF on PharmaCompass.
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