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PharmaCompass offers a list of Pregabalin 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 Pregabalin manufacturer or Pregabalin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pregabalin manufacturer or Pregabalin supplier.
PharmaCompass also assists you with knowing the Pregabalin API Price utilized in the formulation of products. Pregabalin API Price is not always fixed or binding as the Pregabalin Price is obtained through a variety of data sources. The Pregabalin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pregabalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pregabalin, including repackagers and relabelers. The FDA regulates Pregabalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pregabalin 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 Pregabalin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pregabalin supplier is an individual or a company that provides Pregabalin active pharmaceutical ingredient (API) or Pregabalin finished formulations upon request. The Pregabalin suppliers may include Pregabalin API manufacturers, exporters, distributors and traders.
click here to find a list of Pregabalin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pregabalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pregabalin active pharmaceutical ingredient (API) in detail. Different forms of Pregabalin DMFs exist exist since differing nations have different regulations, such as Pregabalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pregabalin DMF submitted to regulatory agencies in the US is known as a USDMF. Pregabalin USDMF includes data on Pregabalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pregabalin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pregabalin 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 Pregabalin Drug Master File in Japan (Pregabalin JDMF) empowers Pregabalin 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 Pregabalin JDMF during the approval evaluation for pharmaceutical products. At the time of Pregabalin 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 Pregabalin 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 Pregabalin Drug Master File in Korea (Pregabalin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pregabalin. The MFDS reviews the Pregabalin KDMF as part of the drug registration process and uses the information provided in the Pregabalin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pregabalin 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 Pregabalin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pregabalin suppliers with KDMF on PharmaCompass.
A Pregabalin CEP of the European Pharmacopoeia monograph is often referred to as a Pregabalin Certificate of Suitability (COS). The purpose of a Pregabalin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pregabalin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pregabalin to their clients by showing that a Pregabalin CEP has been issued for it. The manufacturer submits a Pregabalin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pregabalin CEP holder for the record. Additionally, the data presented in the Pregabalin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pregabalin DMF.
A Pregabalin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pregabalin 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 Pregabalin suppliers with CEP (COS) on PharmaCompass.
A Pregabalin written confirmation (Pregabalin WC) is an official document issued by a regulatory agency to a Pregabalin manufacturer, verifying that the manufacturing facility of a Pregabalin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pregabalin APIs or Pregabalin finished pharmaceutical products to another nation, regulatory agencies frequently require a Pregabalin WC (written confirmation) as part of the regulatory process.
click here to find a list of Pregabalin 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 Pregabalin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pregabalin 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 Pregabalin 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 Pregabalin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pregabalin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pregabalin suppliers with NDC on PharmaCompass.
Pregabalin 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 Pregabalin 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 Pregabalin GMP manufacturer or Pregabalin GMP API supplier for your needs.
A Pregabalin CoA (Certificate of Analysis) is a formal document that attests to Pregabalin's compliance with Pregabalin specifications and serves as a tool for batch-level quality control.
Pregabalin CoA mostly includes findings from lab analyses of a specific batch. For each Pregabalin 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.
Pregabalin may be tested according to a variety of international standards, such as European Pharmacopoeia (Pregabalin EP), Pregabalin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pregabalin USP).
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