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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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NDC 
KDMF
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.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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.
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
Sichuan Qingmu Pharmaceutical offers reliable CDMO support and high-quality APIs for regulated markets.
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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
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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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-07
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Date of Issue : 2022-08-24
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit ?IV, MIDC, Tarapur?401506, Taluka: Palghar, Di...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Nilotinib 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 Nilotinib manufacturer or Nilotinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nilotinib manufacturer or Nilotinib supplier.
PharmaCompass also assists you with knowing the Nilotinib API Price utilized in the formulation of products. Nilotinib API Price is not always fixed or binding as the Nilotinib Price is obtained through a variety of data sources. The Nilotinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nilotinib HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilotinib HCl, including repackagers and relabelers. The FDA regulates Nilotinib HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilotinib HCl 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 Nilotinib HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilotinib HCl supplier is an individual or a company that provides Nilotinib HCl active pharmaceutical ingredient (API) or Nilotinib HCl finished formulations upon request. The Nilotinib HCl suppliers may include Nilotinib HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Nilotinib HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilotinib HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilotinib HCl active pharmaceutical ingredient (API) in detail. Different forms of Nilotinib HCl DMFs exist exist since differing nations have different regulations, such as Nilotinib HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilotinib HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Nilotinib HCl USDMF includes data on Nilotinib HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilotinib HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilotinib HCl 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 Nilotinib HCl Drug Master File in Japan (Nilotinib HCl JDMF) empowers Nilotinib HCl 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 Nilotinib HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Nilotinib HCl 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 Nilotinib HCl 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 Nilotinib HCl Drug Master File in Korea (Nilotinib HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nilotinib HCl. The MFDS reviews the Nilotinib HCl KDMF as part of the drug registration process and uses the information provided in the Nilotinib HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nilotinib HCl 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 Nilotinib HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nilotinib HCl suppliers with KDMF on PharmaCompass.
A Nilotinib HCl CEP of the European Pharmacopoeia monograph is often referred to as a Nilotinib HCl Certificate of Suitability (COS). The purpose of a Nilotinib HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nilotinib HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nilotinib HCl to their clients by showing that a Nilotinib HCl CEP has been issued for it. The manufacturer submits a Nilotinib HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nilotinib HCl CEP holder for the record. Additionally, the data presented in the Nilotinib HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nilotinib HCl DMF.
A Nilotinib HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nilotinib HCl 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 Nilotinib HCl suppliers with CEP (COS) on PharmaCompass.
A Nilotinib HCl written confirmation (Nilotinib HCl WC) is an official document issued by a regulatory agency to a Nilotinib HCl manufacturer, verifying that the manufacturing facility of a Nilotinib HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nilotinib HCl APIs or Nilotinib HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Nilotinib HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Nilotinib HCl 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 Nilotinib HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nilotinib HCl 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 Nilotinib HCl 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 Nilotinib HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nilotinib HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nilotinib HCl suppliers with NDC on PharmaCompass.
Nilotinib HCl 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 Nilotinib HCl 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 Nilotinib HCl GMP manufacturer or Nilotinib HCl GMP API supplier for your needs.
A Nilotinib HCl CoA (Certificate of Analysis) is a formal document that attests to Nilotinib HCl's compliance with Nilotinib HCl specifications and serves as a tool for batch-level quality control.
Nilotinib HCl CoA mostly includes findings from lab analyses of a specific batch. For each Nilotinib HCl 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.
Nilotinib HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Nilotinib HCl EP), Nilotinib HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nilotinib HCl USP).
