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USP
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34164
Submission : 2019-09-30
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-28
DMF Number : 35201
Submission : 2020-09-28
Status :
Type : II
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-511n
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Date of Issue : 2025-02-27
Valid Till : 2028-02-26
Written Confirmation Number : WC-0511
Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
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...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
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...
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...
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
About the Company : Enaltec, founded in 2006, specializes in developing and manufacturing complex, small-volume, technology-driven APIs at competitive prices, leveraging the India advantage for global...
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 207145
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 207145
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ABOUT THIS PAGE
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PharmaCompass offers a list of Safinamide Methanesulfonate 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 Safinamide Methanesulfonate manufacturer or Safinamide Methanesulfonate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Safinamide Methanesulfonate manufacturer or Safinamide Methanesulfonate supplier.
PharmaCompass also assists you with knowing the Safinamide Methanesulfonate API Price utilized in the formulation of products. Safinamide Methanesulfonate API Price is not always fixed or binding as the Safinamide Methanesulfonate Price is obtained through a variety of data sources. The Safinamide Methanesulfonate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Safinamide Methanesulfonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Safinamide Methanesulfonate, including repackagers and relabelers. The FDA regulates Safinamide Methanesulfonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Safinamide Methanesulfonate 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 Safinamide Methanesulfonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Safinamide Methanesulfonate supplier is an individual or a company that provides Safinamide Methanesulfonate active pharmaceutical ingredient (API) or Safinamide Methanesulfonate finished formulations upon request. The Safinamide Methanesulfonate suppliers may include Safinamide Methanesulfonate API manufacturers, exporters, distributors and traders.
click here to find a list of Safinamide Methanesulfonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Safinamide Methanesulfonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Safinamide Methanesulfonate active pharmaceutical ingredient (API) in detail. Different forms of Safinamide Methanesulfonate DMFs exist exist since differing nations have different regulations, such as Safinamide Methanesulfonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Safinamide Methanesulfonate DMF submitted to regulatory agencies in the US is known as a USDMF. Safinamide Methanesulfonate USDMF includes data on Safinamide Methanesulfonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Safinamide Methanesulfonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Safinamide Methanesulfonate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Safinamide Methanesulfonate Drug Master File in Japan (Safinamide Methanesulfonate JDMF) empowers Safinamide Methanesulfonate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Safinamide Methanesulfonate JDMF during the approval evaluation for pharmaceutical products. At the time of Safinamide Methanesulfonate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Safinamide Methanesulfonate suppliers with JDMF 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 Safinamide Methanesulfonate Drug Master File in Korea (Safinamide Methanesulfonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Safinamide Methanesulfonate. The MFDS reviews the Safinamide Methanesulfonate KDMF as part of the drug registration process and uses the information provided in the Safinamide Methanesulfonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Safinamide Methanesulfonate 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 Safinamide Methanesulfonate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Safinamide Methanesulfonate suppliers with KDMF on PharmaCompass.
A Safinamide Methanesulfonate written confirmation (Safinamide Methanesulfonate WC) is an official document issued by a regulatory agency to a Safinamide Methanesulfonate manufacturer, verifying that the manufacturing facility of a Safinamide Methanesulfonate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Safinamide Methanesulfonate APIs or Safinamide Methanesulfonate finished pharmaceutical products to another nation, regulatory agencies frequently require a Safinamide Methanesulfonate WC (written confirmation) as part of the regulatory process.
click here to find a list of Safinamide Methanesulfonate 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 Safinamide Methanesulfonate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Safinamide Methanesulfonate 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 Safinamide Methanesulfonate 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 Safinamide Methanesulfonate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Safinamide Methanesulfonate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Safinamide Methanesulfonate suppliers with NDC on PharmaCompass.
Safinamide Methanesulfonate 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 Safinamide Methanesulfonate 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 Safinamide Methanesulfonate GMP manufacturer or Safinamide Methanesulfonate GMP API supplier for your needs.
A Safinamide Methanesulfonate CoA (Certificate of Analysis) is a formal document that attests to Safinamide Methanesulfonate's compliance with Safinamide Methanesulfonate specifications and serves as a tool for batch-level quality control.
Safinamide Methanesulfonate CoA mostly includes findings from lab analyses of a specific batch. For each Safinamide Methanesulfonate 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.
Safinamide Methanesulfonate may be tested according to a variety of international standards, such as European Pharmacopoeia (Safinamide Methanesulfonate EP), Safinamide Methanesulfonate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Safinamide Methanesulfonate USP).
