Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Pharmaceutical Works POLPHARMA S. A.
01 1Ibandronate Sodium Hydrate
01 1Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies 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 : 2021-07-20
A Ibandronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronic Acid, including repackagers and relabelers. The FDA regulates Ibandronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronic Acid 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 Ibandronic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibandronic Acid supplier is an individual or a company that provides Ibandronic Acid active pharmaceutical ingredient (API) or Ibandronic Acid finished formulations upon request. The Ibandronic Acid suppliers may include Ibandronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronic Acid 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 Ibandronic Acid Drug Master File in Japan (Ibandronic Acid JDMF) empowers Ibandronic Acid 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 Ibandronic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Ibandronic Acid 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 Ibandronic Acid suppliers with JDMF on PharmaCompass.
We have 1 companies offering Ibandronic Acid
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