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API SUPPLIERS
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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 : 2025-02-03
Pay. Date : 2024-12-11
DMF Number : 34676
Submission : 2020-03-12
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-11
Pay. Date : 2018-08-31
DMF Number : 32400
Submission : 2018-02-23
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 : 38065
Submission : 2023-03-31
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 : 35270
Submission : 2020-11-23
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 : 2017-05-10
Pay. Date : 2017-04-03
DMF Number : 31605
Submission : 2017-04-18
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 : 2018-03-20
Pay. Date : 2017-11-28
DMF Number : 32407
Submission : 2018-01-31
Status :
Type : II
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ANALYTICAL
ABOUT THIS PAGE
96
PharmaCompass offers a list of Dasatinib 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 Dasatinib manufacturer or Dasatinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dasatinib manufacturer or Dasatinib supplier.
PharmaCompass also assists you with knowing the Dasatinib API Price utilized in the formulation of products. Dasatinib API Price is not always fixed or binding as the Dasatinib Price is obtained through a variety of data sources. The Dasatinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dasatinib anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dasatinib anhydrous, including repackagers and relabelers. The FDA regulates Dasatinib anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dasatinib anhydrous 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 Dasatinib anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dasatinib anhydrous supplier is an individual or a company that provides Dasatinib anhydrous active pharmaceutical ingredient (API) or Dasatinib anhydrous finished formulations upon request. The Dasatinib anhydrous suppliers may include Dasatinib anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of Dasatinib anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dasatinib anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of Dasatinib anhydrous active pharmaceutical ingredient (API) in detail. Different forms of Dasatinib anhydrous DMFs exist exist since differing nations have different regulations, such as Dasatinib anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dasatinib anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. Dasatinib anhydrous USDMF includes data on Dasatinib anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dasatinib anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dasatinib anhydrous 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 Dasatinib anhydrous Drug Master File in Japan (Dasatinib anhydrous JDMF) empowers Dasatinib anhydrous 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 Dasatinib anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of Dasatinib anhydrous 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 Dasatinib anhydrous 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 Dasatinib anhydrous Drug Master File in Korea (Dasatinib anhydrous KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dasatinib anhydrous. The MFDS reviews the Dasatinib anhydrous KDMF as part of the drug registration process and uses the information provided in the Dasatinib anhydrous KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dasatinib anhydrous 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 Dasatinib anhydrous API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dasatinib anhydrous suppliers with KDMF on PharmaCompass.
A Dasatinib anhydrous written confirmation (Dasatinib anhydrous WC) is an official document issued by a regulatory agency to a Dasatinib anhydrous manufacturer, verifying that the manufacturing facility of a Dasatinib anhydrous active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dasatinib anhydrous APIs or Dasatinib anhydrous finished pharmaceutical products to another nation, regulatory agencies frequently require a Dasatinib anhydrous WC (written confirmation) as part of the regulatory process.
click here to find a list of Dasatinib anhydrous 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 Dasatinib anhydrous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dasatinib anhydrous 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 Dasatinib anhydrous 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 Dasatinib anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dasatinib anhydrous NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dasatinib anhydrous suppliers with NDC on PharmaCompass.
Dasatinib anhydrous 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 Dasatinib anhydrous 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 Dasatinib anhydrous GMP manufacturer or Dasatinib anhydrous GMP API supplier for your needs.
A Dasatinib anhydrous CoA (Certificate of Analysis) is a formal document that attests to Dasatinib anhydrous's compliance with Dasatinib anhydrous specifications and serves as a tool for batch-level quality control.
Dasatinib anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each Dasatinib anhydrous 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.
Dasatinib anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (Dasatinib anhydrous EP), Dasatinib anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dasatinib anhydrous USP).
