Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Pharmaceutical Works POLPHARMA S. A.
02 1Excella GmbH & Co. K.G.
01 2Baclofen
01 1Luxembourg
02 1Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registration Number : 230MF10014
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2018-01-30
Latest Date of Registration : 2019-03-19
Registration Number : 220MF10253
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2008-12-12
Latest Date of Registration : 2008-12-12
A Baclofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baclofen, including repackagers and relabelers. The FDA regulates Baclofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baclofen 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 Baclofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Baclofen supplier is an individual or a company that provides Baclofen active pharmaceutical ingredient (API) or Baclofen finished formulations upon request. The Baclofen suppliers may include Baclofen API manufacturers, exporters, distributors and traders.
click here to find a list of Baclofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Baclofen Drug Master File in Japan (Baclofen JDMF) empowers Baclofen API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Baclofen JDMF during the approval evaluation for pharmaceutical products. At the time of Baclofen JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Baclofen suppliers with JDMF on PharmaCompass.
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