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API SUPPLIERS
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.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39342
Submission : 2023-12-29
Status :
Type : II
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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 ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Drugs in Development
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Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
(1R,5S)-3-ethylbicyclo[3.2.0]hept-3- en-6-one
CAS Number : 1235479-61-4
End Use API : Mirogabalin Besylate
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
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ABOUT THIS PAGE
A Mirogabalin Besilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin Besilate, including repackagers and relabelers. The FDA regulates Mirogabalin Besilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin Besilate 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 Mirogabalin Besilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirogabalin Besilate supplier is an individual or a company that provides Mirogabalin Besilate active pharmaceutical ingredient (API) or Mirogabalin Besilate finished formulations upon request. The Mirogabalin Besilate suppliers may include Mirogabalin Besilate API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin Besilate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirogabalin Besilate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin Besilate active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin Besilate DMFs exist exist since differing nations have different regulations, such as Mirogabalin Besilate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin Besilate DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin Besilate USDMF includes data on Mirogabalin Besilate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin Besilate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin Besilate 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 Mirogabalin Besilate Drug Master File in Korea (Mirogabalin Besilate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirogabalin Besilate. The MFDS reviews the Mirogabalin Besilate KDMF as part of the drug registration process and uses the information provided in the Mirogabalin Besilate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirogabalin Besilate 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 Mirogabalin Besilate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirogabalin Besilate suppliers with KDMF on PharmaCompass.
Mirogabalin Besilate 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 Mirogabalin Besilate 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 Mirogabalin Besilate GMP manufacturer or Mirogabalin Besilate GMP API supplier for your needs.
A Mirogabalin Besilate CoA (Certificate of Analysis) is a formal document that attests to Mirogabalin Besilate's compliance with Mirogabalin Besilate specifications and serves as a tool for batch-level quality control.
Mirogabalin Besilate CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin Besilate 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.
Mirogabalin Besilate may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirogabalin Besilate EP), Mirogabalin Besilate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirogabalin Besilate USP).
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