Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
01 1Laboratory Ofichem B. V.
01 1PAMIDRONATE DISODIUM PENTAHYDRATE
01 1Netherlands
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
PAMIDRONATE DISODIUM PENTAHYDRATE
Registration Number : 228MF10223
Registrant's Address : Heembadweg 5, 9561 CZ Ter apel, The Netherlands
Initial Date of Registration : 2016-11-25
Latest Date of Registration : 2024-10-31
A Pamidronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pamidronic Acid, including repackagers and relabelers. The FDA regulates Pamidronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pamidronic 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 Pamidronic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pamidronic Acid supplier is an individual or a company that provides Pamidronic Acid active pharmaceutical ingredient (API) or Pamidronic Acid finished formulations upon request. The Pamidronic Acid suppliers may include Pamidronic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Pamidronic 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 Pamidronic Acid Drug Master File in Japan (Pamidronic Acid JDMF) empowers Pamidronic 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 Pamidronic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Pamidronic 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 Pamidronic Acid suppliers with JDMF on PharmaCompass.
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