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List of Drug Master Files (JDMF) for Gabapentin Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 HIKAL LIMITED. (1)

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01 Gabapentin (1)

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01 India (1)

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222MF10223
Great Eastern Chambers, CBD Belapur...
2013-01-18
2010-09-03
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Looking for 60142-96-3 / Gabapentin API manufacturers, exporters & distributors?

Gabapentin manufacturers, exporters & distributors 1

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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.

API | Excipient name

Gabapentin

Synonyms

60142-96-3, Neurontin, 1-(aminomethyl)cyclohexaneacetic acid, Gabapentine, Aclonium, 2-[1-(aminomethyl)cyclohexyl]acetic acid

Cas Number

60142-96-3

Unique Ingredient Identifier (UNII)

6CW7F3G59X

About Gabapentin

A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.

Gabapentin Manufacturers

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.

Gabapentin Suppliers

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.

Gabapentin JDMF

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.

Gabapentin Manufacturers | Traders | Suppliers

Gabapentin Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Gabapentin

Get in contact with the supplier of your choice:

  1. Hikal
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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