European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
01 1Pharmaceutical Works POLPHARMA S. A.
01 1Ibandronate Sodium Hydrate
01 1Poland
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Ibandronate Sodium Monohydrate
Registration Number : 303MF10116
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2021-07-20
Latest Date of Registration : 2025-03-19
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A Ibandronate sodium salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronate sodium salt, including repackagers and relabelers. The FDA regulates Ibandronate sodium salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronate sodium salt 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 Ibandronate sodium salt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ibandronate sodium salt supplier is an individual or a company that provides Ibandronate sodium salt active pharmaceutical ingredient (API) or Ibandronate sodium salt finished formulations upon request. The Ibandronate sodium salt suppliers may include Ibandronate sodium salt API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronate sodium salt 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 Ibandronate sodium salt Drug Master File in Japan (Ibandronate sodium salt JDMF) empowers Ibandronate sodium salt 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 Ibandronate sodium salt JDMF during the approval evaluation for pharmaceutical products. At the time of Ibandronate sodium salt 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 Ibandronate sodium salt suppliers with JDMF on PharmaCompass.
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