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API SUPPLIERS
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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
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
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38908
Submission : 2023-09-20
Status :
Type : II
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Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Date of Issue : 2022-06-15
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy. No. 10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 50...
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2025-03-11
Registration Number : Su69-20-ND
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post: Karakhadi-391450, Taluka: Padra, District : Vado...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Lee Sung International Co., Ltd.
Registration Date : 2024-06-14
Registration Number : Thu21-27-ND
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No.10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telang...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2025-04-02
Registration Number : Thu21-27-ND(B)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Sy no. 10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Pharmawon Co., Ltd.
Registration Date : 2025-06-02
Registration Number : Thu21-27-ND(5)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Samjin Pharmaceutical Co., Ltd.
Registration Date : 2025-03-17
Registration Number : Thu21-27-ND(4)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2025-03-14
Registration Number : Thu21-27-ND(3)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-07-17
Registration Number : Thu21-27-ND(1)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No.10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telang...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Grace Farm
Registration Date : 2024-07-17
Registration Number : 21-27-ND(A)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Sy. No. 10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangan...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2025-02-28
Registration Number : Thu21-27-ND(2)
Manufacturer Name : Lee Pharma Limited
Manufacturer Address : Survey No. 10/G-1, Gaddapotharam Village Jinnaram Mandal, Sangareddy District Telanga...
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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...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
About the Company : Lee Pharma Ltd, established in 1997, is a research-driven pharmaceutical company focused on developing, synthesizing, and commercializing high-quality APIs, intermediates, and fini...
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 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...
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, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...
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 a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
Sichuan Qingmu Pharmaceutical offers reliable CDMO support and high-quality APIs for regulated markets.
About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and ...
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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, Price,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.
PharmaCompass also assists you with knowing the Mirogabalin Besylate API Price utilized in the formulation of products. Mirogabalin Besylate API Price is not always fixed or binding as the Mirogabalin Besylate Price is obtained through a variety of data sources. The Mirogabalin Besylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mirogabalin Besylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin Besylate, including repackagers and relabelers. The FDA regulates Mirogabalin Besylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin Besylate 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 Besylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirogabalin Besylate supplier is an individual or a company that provides Mirogabalin Besylate active pharmaceutical ingredient (API) or Mirogabalin Besylate finished formulations upon request. The Mirogabalin Besylate suppliers may include Mirogabalin Besylate API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin Besylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirogabalin Besylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin Besylate active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin Besylate DMFs exist exist since differing nations have different regulations, such as Mirogabalin Besylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin Besylate DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin Besylate USDMF includes data on Mirogabalin Besylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin Besylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin Besylate 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 Besylate Drug Master File in Korea (Mirogabalin Besylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirogabalin Besylate. The MFDS reviews the Mirogabalin Besylate KDMF as part of the drug registration process and uses the information provided in the Mirogabalin Besylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirogabalin Besylate 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 Besylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirogabalin Besylate suppliers with KDMF on PharmaCompass.
A Mirogabalin Besylate written confirmation (Mirogabalin Besylate WC) is an official document issued by a regulatory agency to a Mirogabalin Besylate manufacturer, verifying that the manufacturing facility of a Mirogabalin Besylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mirogabalin Besylate APIs or Mirogabalin Besylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Mirogabalin Besylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Mirogabalin Besylate 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 Mirogabalin Besylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mirogabalin Besylate 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 Besylate 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 Besylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirogabalin Besylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mirogabalin Besylate suppliers with NDC on PharmaCompass.
Mirogabalin Besylate 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 Besylate 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 Besylate GMP manufacturer or Mirogabalin Besylate GMP API supplier for your needs.
A Mirogabalin Besylate CoA (Certificate of Analysis) is a formal document that attests to Mirogabalin Besylate's compliance with Mirogabalin Besylate specifications and serves as a tool for batch-level quality control.
Mirogabalin Besylate CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin Besylate 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 Besylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirogabalin Besylate EP), Mirogabalin Besylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirogabalin Besylate USP).
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