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List of Drug Master Files (DMF) of Gabapentin Enacarbil Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aurobindo Pharma Limited (1)

02 Dasami Lab (1)

03 Glenmark Life Sciences (1)

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01 GABAPENTIN ENACARBIL (3)

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01 India (3)

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01 Active (3)

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01 Complete (3)

URL Supplier Web Content
39197
Active
2023-12-01
Complete
2023-12-20
2023-11-29
II
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URL Supplier Web Content
33386
Active
2019-03-29
Complete
2019-05-10
2019-02-21
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URL Supplier Web Content
33296
Active
2018-11-02
Complete
2018-11-21
2018-11-02
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Looking for 478296-72-9 / Gabapentin Enacarbil API manufacturers, exporters & distributors?

Gabapentin Enacarbil manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Gabapentin Enacarbil 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 Enacarbil manufacturer or Gabapentin Enacarbil supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gabapentin Enacarbil manufacturer or Gabapentin Enacarbil supplier.

PharmaCompass also assists you with knowing the Gabapentin Enacarbil API Price utilized in the formulation of products. Gabapentin Enacarbil API Price is not always fixed or binding as the Gabapentin Enacarbil Price is obtained through a variety of data sources. The Gabapentin Enacarbil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gabapentin Enacarbil

Synonyms

478296-72-9, Horizant, Regnite, Xp-13512, Solzira, Xp13512

Cas Number

478296-72-9

Unique Ingredient Identifier (UNII)

75OCL1SPBQ

About Gabapentin Enacarbil

Gabapentin enacarbil is marketed under the name Horizant. It is a prodrug of gabapentin, and indicated in adults for the treatment of Restless Legs Syndrome (RLS) and postherpetic neuralgia (PHN).

Gabapentin Enacarbil Manufacturers

A Gabapentin Enacarbil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabapentin Enacarbil, including repackagers and relabelers. The FDA regulates Gabapentin Enacarbil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabapentin Enacarbil 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 Enacarbil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Gabapentin Enacarbil Suppliers

A Gabapentin Enacarbil supplier is an individual or a company that provides Gabapentin Enacarbil active pharmaceutical ingredient (API) or Gabapentin Enacarbil finished formulations upon request. The Gabapentin Enacarbil suppliers may include Gabapentin Enacarbil API manufacturers, exporters, distributors and traders.

click here to find a list of Gabapentin Enacarbil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Gabapentin Enacarbil USDMF

A Gabapentin Enacarbil DMF (Drug Master File) is a document detailing the whole manufacturing process of Gabapentin Enacarbil active pharmaceutical ingredient (API) in detail. Different forms of Gabapentin Enacarbil DMFs exist exist since differing nations have different regulations, such as Gabapentin Enacarbil USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Gabapentin Enacarbil DMF submitted to regulatory agencies in the US is known as a USDMF. Gabapentin Enacarbil USDMF includes data on Gabapentin Enacarbil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gabapentin Enacarbil USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Gabapentin Enacarbil suppliers with USDMF on PharmaCompass.

Gabapentin Enacarbil Manufacturers | Traders | Suppliers

Gabapentin Enacarbil Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Gabapentin Enacarbil

Get in contact with the supplier of your choice:

  1. Aurobindo Pharma Limited
  2. Dasami Lab
  3. Glenmark Life Sciences
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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