Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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Weekly News Recap #Phispers
API SUPPLIERS
Inke S.A: APIs manufacturing plant.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
EU-WC
NDC
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Minakem is manufacturing small molecules APIs including corticosteroids
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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.
With Virupaksha, you get a quality product with on-time delivery.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
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USDMF
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-15
Pay. Date : 2020-08-03
DMF Number : 35066
Submission : 2020-08-05
Status :
Type : II
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38912
Submission : 2023-09-26
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37205
Submission : 2022-06-24
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37979
Submission : 2023-02-21
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36341
Submission : 2021-11-03
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38304
Submission : 2023-06-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm : Plot No. 111, SIDCO Industrial Estate, Kakkalur, Thiruvallur 602 003, Tamil Nadu...
With Virupaksha, you get a quality product with on-time delivery.
Date of Issue : 2025-10-01
Valid Till : 2028-09-30
Written Confirmation Number : WC-0191
Address of the Firm : Sy. No. 10, Gaddapotharam (V), Jinnaram (M), Sangareddy District 502319, Telanga...
Neuland Laboratories- A dedicated 100% API provider.
Date of Issue : 2025-06-27
Valid Till : 2028-06-16
Written Confirmation Number : WC-0037
Address of the Firm : Unit-ll, Plot No. 92-94, 257-259, IDA Pashamylaram, Pashamylaram Village, Patanc...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...
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&...
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...
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...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
With Virupaksha, you get a quality product with on-time delivery.
methyl 4-(3,5-dichlorobenzamido)-3-hydroxybenzoate
CAS Number : 1184581-58-5
End Use API : Tafamidis Meglumine
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
With Virupaksha, you get a quality product with on-time delivery.
2-(3,5-dichlorophenyl)benzo[d]oxazole-6-carboxylic...
CAS Number : 594839-88-0
End Use API : Tafamidis Meglumine
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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DATA COMPILATION #PharmaFlow
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NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tafamidis Meglumine 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 Tafamidis Meglumine manufacturer or Tafamidis Meglumine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tafamidis Meglumine manufacturer or Tafamidis Meglumine supplier.
PharmaCompass also assists you with knowing the Tafamidis Meglumine API Price utilized in the formulation of products. Tafamidis Meglumine API Price is not always fixed or binding as the Tafamidis Meglumine Price is obtained through a variety of data sources. The Tafamidis Meglumine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tafamidis Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tafamidis Meglumine, including repackagers and relabelers. The FDA regulates Tafamidis Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tafamidis Meglumine 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 Tafamidis Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tafamidis Meglumine supplier is an individual or a company that provides Tafamidis Meglumine active pharmaceutical ingredient (API) or Tafamidis Meglumine finished formulations upon request. The Tafamidis Meglumine suppliers may include Tafamidis Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Tafamidis Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tafamidis Meglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tafamidis Meglumine active pharmaceutical ingredient (API) in detail. Different forms of Tafamidis Meglumine DMFs exist exist since differing nations have different regulations, such as Tafamidis Meglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tafamidis Meglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Tafamidis Meglumine USDMF includes data on Tafamidis Meglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tafamidis Meglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tafamidis Meglumine suppliers with USDMF on PharmaCompass.
A Tafamidis Meglumine written confirmation (Tafamidis Meglumine WC) is an official document issued by a regulatory agency to a Tafamidis Meglumine manufacturer, verifying that the manufacturing facility of a Tafamidis Meglumine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tafamidis Meglumine APIs or Tafamidis Meglumine finished pharmaceutical products to another nation, regulatory agencies frequently require a Tafamidis Meglumine WC (written confirmation) as part of the regulatory process.
click here to find a list of Tafamidis Meglumine 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 Tafamidis Meglumine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tafamidis Meglumine 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 Tafamidis Meglumine 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 Tafamidis Meglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tafamidis Meglumine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tafamidis Meglumine suppliers with NDC on PharmaCompass.
Tafamidis Meglumine 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 Tafamidis Meglumine 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 Tafamidis Meglumine GMP manufacturer or Tafamidis Meglumine GMP API supplier for your needs.
A Tafamidis Meglumine CoA (Certificate of Analysis) is a formal document that attests to Tafamidis Meglumine's compliance with Tafamidis Meglumine specifications and serves as a tool for batch-level quality control.
Tafamidis Meglumine CoA mostly includes findings from lab analyses of a specific batch. For each Tafamidis Meglumine 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.
Tafamidis Meglumine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tafamidis Meglumine EP), Tafamidis Meglumine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tafamidis Meglumine USP).
