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API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-10-22
Pay. Date : 2025-09-17
DMF Number : 41015
Submission : 2024-12-28
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2025-12-16
Pay. Date : 2025-11-18
DMF Number : 41872
Submission : 2025-07-01
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2026-01-20
Pay. Date : 2025-11-28
DMF Number : 43091
Submission : 2025-11-27
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.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111, SIDCO Industrial Estate, Kakkalur, Thiruvallur 602 003, Tamil Nadu...
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
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, ...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
ApiSyn: From early-phase research and process development to reliable cGMP manufacturing worldwide.
About the Company : Operational since 2024, ApiSyn Healthcare Pvt. Ltd. is a rapidly growing cGMP manufacturer and CDMO specializing in APIs, intermediates, peptides, and amino acids across two dedica...
Hiray Pharma Solutions partners with global innovators to develop, manufacture and commercialize high-quality APIs and intermediates.
About the Company : Hiray Pharma Solutions is a global end-to-end CDMO specializing in APIs and intermediates. The company offers integrated services across Process R&D, Analytical R&D, manufacturing,...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Avatrombopag Maleate 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 Avatrombopag Maleate manufacturer or Avatrombopag Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Avatrombopag Maleate manufacturer or Avatrombopag Maleate supplier.
A Avatrombopag Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avatrombopag Maleate, including repackagers and relabelers. The FDA regulates Avatrombopag Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avatrombopag Maleate 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 Avatrombopag Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Avatrombopag Maleate supplier is an individual or a company that provides Avatrombopag Maleate active pharmaceutical ingredient (API) or Avatrombopag Maleate finished formulations upon request. The Avatrombopag Maleate suppliers may include Avatrombopag Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Avatrombopag Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Avatrombopag Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Avatrombopag Maleate active pharmaceutical ingredient (API) in detail. Different forms of Avatrombopag Maleate DMFs exist exist since differing nations have different regulations, such as Avatrombopag Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avatrombopag Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Avatrombopag Maleate USDMF includes data on Avatrombopag Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avatrombopag Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avatrombopag Maleate suppliers with USDMF 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 Avatrombopag Maleate Drug Master File in Korea (Avatrombopag Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Avatrombopag Maleate. The MFDS reviews the Avatrombopag Maleate KDMF as part of the drug registration process and uses the information provided in the Avatrombopag Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Avatrombopag Maleate 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 Avatrombopag Maleate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Avatrombopag Maleate suppliers with KDMF on PharmaCompass.
A Avatrombopag Maleate written confirmation (Avatrombopag Maleate WC) is an official document issued by a regulatory agency to a Avatrombopag Maleate manufacturer, verifying that the manufacturing facility of a Avatrombopag Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Avatrombopag Maleate APIs or Avatrombopag Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Avatrombopag Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Avatrombopag Maleate 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 Avatrombopag Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Avatrombopag Maleate 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 Avatrombopag Maleate 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 Avatrombopag Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Avatrombopag Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Avatrombopag Maleate suppliers with NDC on PharmaCompass.
Avatrombopag Maleate 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 Avatrombopag Maleate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Avatrombopag Maleate GMP manufacturer or Avatrombopag Maleate GMP API supplier for your needs.
A Avatrombopag Maleate CoA (Certificate of Analysis) is a formal document that attests to Avatrombopag Maleate's compliance with Avatrombopag Maleate specifications and serves as a tool for batch-level quality control.
Avatrombopag Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Avatrombopag Maleate 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.
Avatrombopag Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Avatrombopag Maleate EP), Avatrombopag Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Avatrombopag Maleate USP).
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