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Weekly News Recap #Phispers
API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
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.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
HRV Pharma - 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.
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
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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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 43272
Submission : 2025-12-30
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 : 2025-07-15
Valid Till : 2028-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operation
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
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, Dis...
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Gangwal Healthcare
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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 hydrochloride anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nilotinib hydrochloride anhydrous, including repackagers and relabelers. The FDA regulates Nilotinib hydrochloride anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nilotinib hydrochloride anhydrous supplier is an individual or a company that provides Nilotinib hydrochloride anhydrous active pharmaceutical ingredient (API) or Nilotinib hydrochloride anhydrous finished formulations upon request. The Nilotinib hydrochloride anhydrous suppliers may include Nilotinib hydrochloride anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of Nilotinib hydrochloride anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nilotinib hydrochloride anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilotinib hydrochloride anhydrous active pharmaceutical ingredient (API) in detail. Different forms of Nilotinib hydrochloride anhydrous DMFs exist exist since differing nations have different regulations, such as Nilotinib hydrochloride anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nilotinib hydrochloride anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. Nilotinib hydrochloride anhydrous USDMF includes data on Nilotinib hydrochloride anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilotinib hydrochloride anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous Drug Master File in Japan (Nilotinib hydrochloride anhydrous JDMF) empowers Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of Nilotinib hydrochloride 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 Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous Drug Master File in Korea (Nilotinib hydrochloride anhydrous KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nilotinib hydrochloride anhydrous. The MFDS reviews the Nilotinib hydrochloride anhydrous KDMF as part of the drug registration process and uses the information provided in the Nilotinib hydrochloride anhydrous KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nilotinib hydrochloride anhydrous suppliers with KDMF on PharmaCompass.
A Nilotinib hydrochloride anhydrous CEP of the European Pharmacopoeia monograph is often referred to as a Nilotinib hydrochloride anhydrous Certificate of Suitability (COS). The purpose of a Nilotinib hydrochloride anhydrous CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nilotinib hydrochloride anhydrous EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nilotinib hydrochloride anhydrous to their clients by showing that a Nilotinib hydrochloride anhydrous CEP has been issued for it. The manufacturer submits a Nilotinib hydrochloride anhydrous CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nilotinib hydrochloride anhydrous CEP holder for the record. Additionally, the data presented in the Nilotinib hydrochloride anhydrous CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nilotinib hydrochloride anhydrous DMF.
A Nilotinib hydrochloride anhydrous CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nilotinib hydrochloride anhydrous 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 hydrochloride anhydrous suppliers with CEP (COS) on PharmaCompass.
A Nilotinib hydrochloride anhydrous written confirmation (Nilotinib hydrochloride anhydrous WC) is an official document issued by a regulatory agency to a Nilotinib hydrochloride anhydrous manufacturer, verifying that the manufacturing facility of a Nilotinib hydrochloride anhydrous active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nilotinib hydrochloride anhydrous APIs or Nilotinib hydrochloride anhydrous finished pharmaceutical products to another nation, regulatory agencies frequently require a Nilotinib hydrochloride anhydrous WC (written confirmation) as part of the regulatory process.
click here to find a list of Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nilotinib hydrochloride 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 Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nilotinib hydrochloride anhydrous NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nilotinib hydrochloride anhydrous suppliers with NDC on PharmaCompass.
Nilotinib hydrochloride 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 Nilotinib hydrochloride 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 Nilotinib hydrochloride anhydrous GMP manufacturer or Nilotinib hydrochloride anhydrous GMP API supplier for your needs.
A Nilotinib hydrochloride anhydrous CoA (Certificate of Analysis) is a formal document that attests to Nilotinib hydrochloride anhydrous's compliance with Nilotinib hydrochloride anhydrous specifications and serves as a tool for batch-level quality control.
Nilotinib hydrochloride anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each Nilotinib hydrochloride 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.
Nilotinib hydrochloride anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (Nilotinib hydrochloride anhydrous EP), Nilotinib hydrochloride anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nilotinib hydrochloride anhydrous USP).
