Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Apicore
04 1Aurobindo Pharma Limited
05 1F.I.S. Fabbrica Italiana Sintetici
06 2MSN Laboratories
07 1Merck Group
08 1Optimus Pharma
09 1Solara Active Pharma Sciences
10 1Zhejiang Huahai Pharmaceutical
11 1Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34164
Submission : 2019-09-30
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-28
DMF Number : 35201
Submission : 2020-09-28
Status :
Type : II
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PharmaCompass offers a list of Safinamide Mesylate 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 Safinamide Mesylate manufacturer or Safinamide Mesylate supplier for your needs.
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A Safinamide Methanesulfonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Safinamide Methanesulfonate, including repackagers and relabelers. The FDA regulates Safinamide Methanesulfonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Safinamide Methanesulfonate 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 Safinamide Methanesulfonate supplier is an individual or a company that provides Safinamide Methanesulfonate active pharmaceutical ingredient (API) or Safinamide Methanesulfonate finished formulations upon request. The Safinamide Methanesulfonate suppliers may include Safinamide Methanesulfonate API manufacturers, exporters, distributors and traders.
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A Safinamide Methanesulfonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Safinamide Methanesulfonate active pharmaceutical ingredient (API) in detail. Different forms of Safinamide Methanesulfonate DMFs exist exist since differing nations have different regulations, such as Safinamide Methanesulfonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Safinamide Methanesulfonate DMF submitted to regulatory agencies in the US is known as a USDMF. Safinamide Methanesulfonate USDMF includes data on Safinamide Methanesulfonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Safinamide Methanesulfonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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