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API SUPPLIERS
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
ASMF
Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
ASMF
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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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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 NW 1015 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NW 1015, including repackagers and relabelers. The FDA regulates NW 1015 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NW 1015 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 NW 1015 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A NW 1015 supplier is an individual or a company that provides NW 1015 active pharmaceutical ingredient (API) or NW 1015 finished formulations upon request. The NW 1015 suppliers may include NW 1015 API manufacturers, exporters, distributors and traders.
click here to find a list of NW 1015 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A NW 1015 DMF (Drug Master File) is a document detailing the whole manufacturing process of NW 1015 active pharmaceutical ingredient (API) in detail. Different forms of NW 1015 DMFs exist exist since differing nations have different regulations, such as NW 1015 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NW 1015 DMF submitted to regulatory agencies in the US is known as a USDMF. NW 1015 USDMF includes data on NW 1015's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NW 1015 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of NW 1015 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 NW 1015 Drug Master File in Japan (NW 1015 JDMF) empowers NW 1015 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 NW 1015 JDMF during the approval evaluation for pharmaceutical products. At the time of NW 1015 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 NW 1015 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 NW 1015 Drug Master File in Korea (NW 1015 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NW 1015. The MFDS reviews the NW 1015 KDMF as part of the drug registration process and uses the information provided in the NW 1015 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NW 1015 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 NW 1015 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of NW 1015 suppliers with KDMF on PharmaCompass.
A NW 1015 written confirmation (NW 1015 WC) is an official document issued by a regulatory agency to a NW 1015 manufacturer, verifying that the manufacturing facility of a NW 1015 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting NW 1015 APIs or NW 1015 finished pharmaceutical products to another nation, regulatory agencies frequently require a NW 1015 WC (written confirmation) as part of the regulatory process.
click here to find a list of NW 1015 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 NW 1015 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for NW 1015 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 NW 1015 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 NW 1015 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a NW 1015 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of NW 1015 suppliers with NDC on PharmaCompass.
NW 1015 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 NW 1015 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 NW 1015 GMP manufacturer or NW 1015 GMP API supplier for your needs.
A NW 1015 CoA (Certificate of Analysis) is a formal document that attests to NW 1015's compliance with NW 1015 specifications and serves as a tool for batch-level quality control.
NW 1015 CoA mostly includes findings from lab analyses of a specific batch. For each NW 1015 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.
NW 1015 may be tested according to a variety of international standards, such as European Pharmacopoeia (NW 1015 EP), NW 1015 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (NW 1015 USP).
