01 1Janssen Pharmaceutica NV
02 1Siegfried PharmaChemikalien Minden GmbH
01 2Buprenorphine
01 1Switzerland
02 1U.S.A
Registration Number : 228MF10073
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2016-03-11
Latest Date of Registration : 2016-03-11
Registration Number : 305MF10007
Registrant's Address : Karlstrasse 15, 32423, Minden, Federal Republic of Germany
Initial Date of Registration : 2023-01-18
Latest Date of Registration : 2024-08-28
A Buprenorphine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buprenorphine, including repackagers and relabelers. The FDA regulates Buprenorphine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buprenorphine 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 Buprenorphine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Buprenorphine supplier is an individual or a company that provides Buprenorphine active pharmaceutical ingredient (API) or Buprenorphine finished formulations upon request. The Buprenorphine suppliers may include Buprenorphine API manufacturers, exporters, distributors and traders.
click here to find a list of Buprenorphine 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 Buprenorphine Drug Master File in Japan (Buprenorphine JDMF) empowers Buprenorphine 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 Buprenorphine JDMF during the approval evaluation for pharmaceutical products. At the time of Buprenorphine 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 Buprenorphine suppliers with JDMF on PharmaCompass.
We have 2 companies offering Buprenorphine
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
