European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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01 1Pharmaceutical Works POLPHARMA S. A.
02 1UBE Co., Ltd.
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01 2Sodium salicylate
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01 1Japan
02 1Poland
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Registration Number : 221MF10220
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2009-10-08
Latest Date of Registration : 2022-11-16
Registration Number : 217MF11237
Registrant's Address : 1978-96 Ogushi, Ube City, Yamaguchi Prefecture
Initial Date of Registration : 2005-12-20
Latest Date of Registration : 2009-12-18

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A MolPort-002-324-170 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-002-324-170, including repackagers and relabelers. The FDA regulates MolPort-002-324-170 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-002-324-170 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 MolPort-002-324-170 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A MolPort-002-324-170 supplier is an individual or a company that provides MolPort-002-324-170 active pharmaceutical ingredient (API) or MolPort-002-324-170 finished formulations upon request. The MolPort-002-324-170 suppliers may include MolPort-002-324-170 API manufacturers, exporters, distributors and traders.
click here to find a list of MolPort-002-324-170 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 MolPort-002-324-170 Drug Master File in Japan (MolPort-002-324-170 JDMF) empowers MolPort-002-324-170 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 MolPort-002-324-170 JDMF during the approval evaluation for pharmaceutical products. At the time of MolPort-002-324-170 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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