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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A NW 1015 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NW 1015, including repackagers and relabelers. The FDA regulates NW 1015 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NW 1015 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 NW 1015 supplier is an individual or a company that provides NW 1015 active pharmaceutical ingredient (API) or NW 1015 finished formulations upon request. The NW 1015 suppliers may include NW 1015 API manufacturers, exporters, distributors and traders.
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A NW 1015 DMF (Drug Master File) is a document detailing the whole manufacturing process of NW 1015 active pharmaceutical ingredient (API) in detail. Different forms of NW 1015 DMFs exist exist since differing nations have different regulations, such as NW 1015 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NW 1015 DMF submitted to regulatory agencies in the US is known as a USDMF. NW 1015 USDMF includes data on NW 1015's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NW 1015 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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