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 Neurontin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neurontin, including repackagers and relabelers. The FDA regulates Neurontin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neurontin 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 Neurontin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neurontin supplier is an individual or a company that provides Neurontin active pharmaceutical ingredient (API) or Neurontin finished formulations upon request. The Neurontin suppliers may include Neurontin API manufacturers, exporters, distributors and traders.
click here to find a list of Neurontin 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 Neurontin Drug Master File in Japan (Neurontin JDMF) empowers Neurontin 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 Neurontin JDMF during the approval evaluation for pharmaceutical products. At the time of Neurontin 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 Neurontin suppliers with JDMF on PharmaCompass.
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