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API SUPPLIERS
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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NDC
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
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USDMF
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-27
DMF Number : 38577
Submission : 2023-09-28
Status :
Type : II
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 22200
Submission : 2008-11-17
Status :
Type : II
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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
About the Company : Established in 2010, ASolution is an India-based custom developer and manufacturer serving pharmaceutical needs across multiple scales. The company provides process development, op...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
About the Company : Founded in 1990 in France, Fareva is a global subcontractor providing R&D, production, and packaging services across pharmaceutical, cosmetics, and industrial sectors. Operating in...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Cevimeline Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cevimeline Hydrochloride manufacturer or Cevimeline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cevimeline Hydrochloride manufacturer or Cevimeline Hydrochloride supplier.
A Cevimeline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cevimeline, including repackagers and relabelers. The FDA regulates Cevimeline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cevimeline 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 Cevimeline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cevimeline supplier is an individual or a company that provides Cevimeline active pharmaceutical ingredient (API) or Cevimeline finished formulations upon request. The Cevimeline suppliers may include Cevimeline API manufacturers, exporters, distributors and traders.
click here to find a list of Cevimeline suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cevimeline DMF (Drug Master File) is a document detailing the whole manufacturing process of Cevimeline active pharmaceutical ingredient (API) in detail. Different forms of Cevimeline DMFs exist exist since differing nations have different regulations, such as Cevimeline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cevimeline DMF submitted to regulatory agencies in the US is known as a USDMF. Cevimeline USDMF includes data on Cevimeline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cevimeline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cevimeline 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 Cevimeline Drug Master File in Japan (Cevimeline JDMF) empowers Cevimeline 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 Cevimeline JDMF during the approval evaluation for pharmaceutical products. At the time of Cevimeline 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 Cevimeline suppliers with JDMF on PharmaCompass.
A Cevimeline written confirmation (Cevimeline WC) is an official document issued by a regulatory agency to a Cevimeline manufacturer, verifying that the manufacturing facility of a Cevimeline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cevimeline APIs or Cevimeline finished pharmaceutical products to another nation, regulatory agencies frequently require a Cevimeline WC (written confirmation) as part of the regulatory process.
click here to find a list of Cevimeline 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 Cevimeline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cevimeline 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 Cevimeline 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 Cevimeline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cevimeline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cevimeline suppliers with NDC on PharmaCompass.
Cevimeline 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 Cevimeline GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cevimeline GMP manufacturer or Cevimeline GMP API supplier for your needs.
A Cevimeline CoA (Certificate of Analysis) is a formal document that attests to Cevimeline's compliance with Cevimeline specifications and serves as a tool for batch-level quality control.
Cevimeline CoA mostly includes findings from lab analyses of a specific batch. For each Cevimeline 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.
Cevimeline may be tested according to a variety of international standards, such as European Pharmacopoeia (Cevimeline EP), Cevimeline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cevimeline USP).
