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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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NDC
KDMF
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
ASMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
NDC
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-16
Pay. Date : 2016-02-04
DMF Number : 30088
Submission : 2015-12-31
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-15
Pay. Date : 2022-08-22
DMF Number : 37161
Submission : 2022-07-08
Status :
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39648
Submission : 2024-03-27
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37531
Submission : 2022-09-30
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-28
Pay. Date : 2020-05-13
DMF Number : 34874
Submission : 2020-07-14
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-13
Pay. Date : 2014-03-19
DMF Number : 28102
Submission : 2014-07-15
Status :
Type : II
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ABOUT THIS PAGE
A Tasigna manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tasigna, including repackagers and relabelers. The FDA regulates Tasigna manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tasigna 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 Tasigna manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tasigna supplier is an individual or a company that provides Tasigna active pharmaceutical ingredient (API) or Tasigna finished formulations upon request. The Tasigna suppliers may include Tasigna API manufacturers, exporters, distributors and traders.
click here to find a list of Tasigna suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tasigna DMF (Drug Master File) is a document detailing the whole manufacturing process of Tasigna active pharmaceutical ingredient (API) in detail. Different forms of Tasigna DMFs exist exist since differing nations have different regulations, such as Tasigna USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tasigna DMF submitted to regulatory agencies in the US is known as a USDMF. Tasigna USDMF includes data on Tasigna's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tasigna USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tasigna 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 Tasigna Drug Master File in Japan (Tasigna JDMF) empowers Tasigna 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 Tasigna JDMF during the approval evaluation for pharmaceutical products. At the time of Tasigna 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 Tasigna 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 Tasigna Drug Master File in Korea (Tasigna KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tasigna. The MFDS reviews the Tasigna KDMF as part of the drug registration process and uses the information provided in the Tasigna KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tasigna 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 Tasigna API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tasigna suppliers with KDMF on PharmaCompass.
A Tasigna CEP of the European Pharmacopoeia monograph is often referred to as a Tasigna Certificate of Suitability (COS). The purpose of a Tasigna CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tasigna EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tasigna to their clients by showing that a Tasigna CEP has been issued for it. The manufacturer submits a Tasigna CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tasigna CEP holder for the record. Additionally, the data presented in the Tasigna CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tasigna DMF.
A Tasigna CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tasigna CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Tasigna suppliers with CEP (COS) on PharmaCompass.
A Tasigna written confirmation (Tasigna WC) is an official document issued by a regulatory agency to a Tasigna manufacturer, verifying that the manufacturing facility of a Tasigna active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tasigna APIs or Tasigna finished pharmaceutical products to another nation, regulatory agencies frequently require a Tasigna WC (written confirmation) as part of the regulatory process.
click here to find a list of Tasigna 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 Tasigna as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tasigna 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 Tasigna 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 Tasigna and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tasigna NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tasigna suppliers with NDC on PharmaCompass.
Tasigna 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 Tasigna 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 Tasigna GMP manufacturer or Tasigna GMP API supplier for your needs.
A Tasigna CoA (Certificate of Analysis) is a formal document that attests to Tasigna's compliance with Tasigna specifications and serves as a tool for batch-level quality control.
Tasigna CoA mostly includes findings from lab analyses of a specific batch. For each Tasigna 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.
Tasigna may be tested according to a variety of international standards, such as European Pharmacopoeia (Tasigna EP), Tasigna JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tasigna USP).
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