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 1MSN Laboratories Private Limited.
01 1Dapagliflozin
02 1Dapagliflozin (Amorphous)
01 1India
02 1Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registration Number : 305MF10084
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2023-07-19
Latest Date of Registration : 2023-07-19
Registration Number : 306MF10106
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2024-07-24
Latest Date of Registration : 2024-07-24
A Dapagliflozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapagliflozin, including repackagers and relabelers. The FDA regulates Dapagliflozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapagliflozin 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 Dapagliflozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapagliflozin supplier is an individual or a company that provides Dapagliflozin active pharmaceutical ingredient (API) or Dapagliflozin finished formulations upon request. The Dapagliflozin suppliers may include Dapagliflozin API manufacturers, exporters, distributors and traders.
click here to find a list of Dapagliflozin 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 Dapagliflozin Drug Master File in Japan (Dapagliflozin JDMF) empowers Dapagliflozin 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 Dapagliflozin JDMF during the approval evaluation for pharmaceutical products. At the time of Dapagliflozin 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 Dapagliflozin suppliers with JDMF on PharmaCompass.
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