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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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Drugs in Development
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Ethyl-4-bromomethyl-2-[N-(2, 6-di-fluorobenzyl)-N-...
CAS Number : 308831-95-0
End Use API : Relugolix
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
2-((2,6-di uorobenzyl)(ethoxy carbonyl)amino)-4- (...
CAS Number : 1589503-95-6
End Use API : Relugolix
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
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A Relugolix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Relugolix, including repackagers and relabelers. The FDA regulates Relugolix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Relugolix 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 Relugolix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Relugolix supplier is an individual or a company that provides Relugolix active pharmaceutical ingredient (API) or Relugolix finished formulations upon request. The Relugolix suppliers may include Relugolix API manufacturers, exporters, distributors and traders.
click here to find a list of Relugolix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Relugolix DMF (Drug Master File) is a document detailing the whole manufacturing process of Relugolix active pharmaceutical ingredient (API) in detail. Different forms of Relugolix DMFs exist exist since differing nations have different regulations, such as Relugolix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Relugolix DMF submitted to regulatory agencies in the US is known as a USDMF. Relugolix USDMF includes data on Relugolix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Relugolix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Relugolix suppliers with USDMF 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 Relugolix as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Relugolix 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 Relugolix 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 Relugolix and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Relugolix NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Relugolix suppliers with NDC on PharmaCompass.
Relugolix 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 Relugolix 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 Relugolix GMP manufacturer or Relugolix GMP API supplier for your needs.
A Relugolix CoA (Certificate of Analysis) is a formal document that attests to Relugolix's compliance with Relugolix specifications and serves as a tool for batch-level quality control.
Relugolix CoA mostly includes findings from lab analyses of a specific batch. For each Relugolix 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.
Relugolix may be tested according to a variety of international standards, such as European Pharmacopoeia (Relugolix EP), Relugolix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Relugolix USP).
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