Registration Number : 222MF10223
Registrant's Address : Great Eastern Chambers, CBD Belapur, Navi Mumbai-400 614, India
Initial Date of Registration : 2010-09-03
Latest Date of Registration : 2013-01-18
A Gabapentin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabapentin, including repackagers and relabelers. The FDA regulates Gabapentin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabapentin 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 Gabapentin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gabapentin supplier is an individual or a company that provides Gabapentin active pharmaceutical ingredient (API) or Gabapentin finished formulations upon request. The Gabapentin suppliers may include Gabapentin API manufacturers, exporters, distributors and traders.
click here to find a list of Gabapentin 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 Gabapentin Drug Master File in Japan (Gabapentin JDMF) empowers Gabapentin 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 Gabapentin JDMF during the approval evaluation for pharmaceutical products. At the time of Gabapentin 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 Gabapentin suppliers with JDMF on PharmaCompass.
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