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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 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.
A Neurontin DMF (Drug Master File) is a document detailing the whole manufacturing process of Neurontin active pharmaceutical ingredient (API) in detail. Different forms of Neurontin DMFs exist exist since differing nations have different regulations, such as Neurontin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Neurontin DMF submitted to regulatory agencies in the US is known as a USDMF. Neurontin USDMF includes data on Neurontin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Neurontin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Neurontin suppliers with USDMF 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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Neurontin Drug Master File in Korea (Neurontin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Neurontin. The MFDS reviews the Neurontin KDMF as part of the drug registration process and uses the information provided in the Neurontin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Neurontin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Neurontin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Neurontin suppliers with KDMF on PharmaCompass.
A Neurontin CEP of the European Pharmacopoeia monograph is often referred to as a Neurontin Certificate of Suitability (COS). The purpose of a Neurontin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Neurontin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Neurontin to their clients by showing that a Neurontin CEP has been issued for it. The manufacturer submits a Neurontin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Neurontin CEP holder for the record. Additionally, the data presented in the Neurontin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Neurontin DMF.
A Neurontin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Neurontin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Neurontin suppliers with CEP (COS) on PharmaCompass.
A Neurontin written confirmation (Neurontin WC) is an official document issued by a regulatory agency to a Neurontin manufacturer, verifying that the manufacturing facility of a Neurontin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Neurontin APIs or Neurontin finished pharmaceutical products to another nation, regulatory agencies frequently require a Neurontin WC (written confirmation) as part of the regulatory process.
click here to find a list of Neurontin suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Neurontin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Neurontin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Neurontin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Neurontin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Neurontin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Neurontin suppliers with NDC on PharmaCompass.
Neurontin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Neurontin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Neurontin GMP manufacturer or Neurontin GMP API supplier for your needs.
A Neurontin CoA (Certificate of Analysis) is a formal document that attests to Neurontin's compliance with Neurontin specifications and serves as a tool for batch-level quality control.
Neurontin CoA mostly includes findings from lab analyses of a specific batch. For each Neurontin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Neurontin may be tested according to a variety of international standards, such as European Pharmacopoeia (Neurontin EP), Neurontin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Neurontin USP).
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