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CEP/COS
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JDMF
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EU WC
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EDQM
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USP
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JP
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FDA Orange Book
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Europe
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DRUG PRODUCT COMPOSITIONS
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US Patents
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Data Compilation #PharmaFlow
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API SUPPLIERS
AMI Lifesciences is Driven by Chemistry. Powered by People.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
AMI Lifesciences is Driven by Chemistry. Powered by People.
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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 : 41196
Submission : 2025-02-12
Status :
Type : II
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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AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
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...
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...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-growth therapeutic ar...
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...
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
About the Company : Sichuan Qingmu Pharmaceutical is an innovation-driven company specializing in generic APIs, advanced intermediates, and CDMO/CMO services for small-molecule drugs. Approved by US F...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Mirogabalin Besylate 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 Mirogabalin Besylate manufacturer or Mirogabalin Besylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mirogabalin Besylate manufacturer or Mirogabalin Besylate supplier.
A Mirogabalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin, including repackagers and relabelers. The FDA regulates Mirogabalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Mirogabalin supplier is an individual or a company that provides Mirogabalin active pharmaceutical ingredient (API) or Mirogabalin finished formulations upon request. The Mirogabalin suppliers may include Mirogabalin API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mirogabalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin DMFs exist exist since differing nations have different regulations, such as Mirogabalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin USDMF includes data on Mirogabalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin 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 Drug Master File in Korea (Mirogabalin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirogabalin. The MFDS reviews the Mirogabalin KDMF as part of the drug registration process and uses the information provided in the Mirogabalin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirogabalin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirogabalin suppliers with KDMF 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 Mirogabalin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mirogabalin 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 Mirogabalin 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 Mirogabalin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirogabalin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mirogabalin suppliers with NDC on PharmaCompass.
Mirogabalin 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 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Mirogabalin GMP manufacturer or Mirogabalin GMP API supplier for your needs.
A Mirogabalin CoA (Certificate of Analysis) is a formal document that attests to Mirogabalin's compliance with Mirogabalin specifications and serves as a tool for batch-level quality control.
Mirogabalin CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirogabalin EP), Mirogabalin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirogabalin USP).
