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API SUPPLIERS
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41227
Submission : 2025-01-20
Status :
Type : II
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Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical is a wholly owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Located in the Qihe Economic Development Zone, Sh...
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...
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...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Daridorexant 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 Daridorexant manufacturer or Daridorexant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Daridorexant manufacturer or Daridorexant supplier.
A Daridorexant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daridorexant, including repackagers and relabelers. The FDA regulates Daridorexant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daridorexant 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 Daridorexant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Daridorexant supplier is an individual or a company that provides Daridorexant active pharmaceutical ingredient (API) or Daridorexant finished formulations upon request. The Daridorexant suppliers may include Daridorexant API manufacturers, exporters, distributors and traders.
click here to find a list of Daridorexant suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Daridorexant DMF (Drug Master File) is a document detailing the whole manufacturing process of Daridorexant active pharmaceutical ingredient (API) in detail. Different forms of Daridorexant DMFs exist exist since differing nations have different regulations, such as Daridorexant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daridorexant DMF submitted to regulatory agencies in the US is known as a USDMF. Daridorexant USDMF includes data on Daridorexant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daridorexant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daridorexant suppliers with USDMF on PharmaCompass.
Daridorexant 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 Daridorexant GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Daridorexant GMP manufacturer or Daridorexant GMP API supplier for your needs.
A Daridorexant CoA (Certificate of Analysis) is a formal document that attests to Daridorexant's compliance with Daridorexant specifications and serves as a tool for batch-level quality control.
Daridorexant CoA mostly includes findings from lab analyses of a specific batch. For each Daridorexant 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.
Daridorexant may be tested according to a variety of international standards, such as European Pharmacopoeia (Daridorexant EP), Daridorexant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Daridorexant USP).
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