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