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
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PharmaCompass offers a list of Gabapentin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gabapentin manufacturer or Gabapentin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gabapentin manufacturer or Gabapentin supplier.
PharmaCompass also assists you with knowing the Gabapentin API Price utilized in the formulation of products. Gabapentin API Price is not always fixed or binding as the Gabapentin Price is obtained through a variety of data sources. The Gabapentin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A G0318 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of G0318, including repackagers and relabelers. The FDA regulates G0318 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. G0318 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A G0318 supplier is an individual or a company that provides G0318 active pharmaceutical ingredient (API) or G0318 finished formulations upon request. The G0318 suppliers may include G0318 API manufacturers, exporters, distributors and traders.
click here to find a list of G0318 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 G0318 Drug Master File in Japan (G0318 JDMF) empowers G0318 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 G0318 JDMF during the approval evaluation for pharmaceutical products. At the time of G0318 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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