01 2F. I. S. Fabrica Italiana Sintetici S. p. A.
01 1Pentazocine
02 1Pentazocine hydrochloride
01 2Italy
Registration Number : 221MF10106
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2009-06-02
Latest Date of Registration : 2017-05-19
Registration Number : 217MF10848
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2017-05-01
A Pentazocine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentazocine, including repackagers and relabelers. The FDA regulates Pentazocine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentazocine 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 Pentazocine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentazocine supplier is an individual or a company that provides Pentazocine active pharmaceutical ingredient (API) or Pentazocine finished formulations upon request. The Pentazocine suppliers may include Pentazocine API manufacturers, exporters, distributors and traders.
click here to find a list of Pentazocine 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 Pentazocine Drug Master File in Japan (Pentazocine JDMF) empowers Pentazocine 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 Pentazocine JDMF during the approval evaluation for pharmaceutical products. At the time of Pentazocine 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 Pentazocine suppliers with JDMF on PharmaCompass.
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