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API SUPPLIERS
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USDMF
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-27
Pay. Date : 2018-01-19
DMF Number : 32140
Submission : 2017-12-20
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 : 37229
Submission : 2022-06-30
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 : 2016-04-01
Pay. Date : 2016-02-01
DMF Number : 30234
Submission : 2016-02-23
Status :
Type : II
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Sorafenib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sorafenib manufacturer or Sorafenib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sorafenib manufacturer or Sorafenib supplier.
A Sorafenib - Nexavar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorafenib - Nexavar, including repackagers and relabelers. The FDA regulates Sorafenib - Nexavar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorafenib - Nexavar 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 Sorafenib - Nexavar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sorafenib - Nexavar supplier is an individual or a company that provides Sorafenib - Nexavar active pharmaceutical ingredient (API) or Sorafenib - Nexavar finished formulations upon request. The Sorafenib - Nexavar suppliers may include Sorafenib - Nexavar API manufacturers, exporters, distributors and traders.
click here to find a list of Sorafenib - Nexavar suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sorafenib - Nexavar DMF (Drug Master File) is a document detailing the whole manufacturing process of Sorafenib - Nexavar active pharmaceutical ingredient (API) in detail. Different forms of Sorafenib - Nexavar DMFs exist exist since differing nations have different regulations, such as Sorafenib - Nexavar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sorafenib - Nexavar DMF submitted to regulatory agencies in the US is known as a USDMF. Sorafenib - Nexavar USDMF includes data on Sorafenib - Nexavar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sorafenib - Nexavar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sorafenib - Nexavar 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 Sorafenib - Nexavar Drug Master File in Japan (Sorafenib - Nexavar JDMF) empowers Sorafenib - Nexavar 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 Sorafenib - Nexavar JDMF during the approval evaluation for pharmaceutical products. At the time of Sorafenib - Nexavar 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 Sorafenib - Nexavar 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 Sorafenib - Nexavar Drug Master File in Korea (Sorafenib - Nexavar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sorafenib - Nexavar. The MFDS reviews the Sorafenib - Nexavar KDMF as part of the drug registration process and uses the information provided in the Sorafenib - Nexavar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sorafenib - Nexavar 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 Sorafenib - Nexavar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sorafenib - Nexavar suppliers with KDMF on PharmaCompass.
A Sorafenib - Nexavar CEP of the European Pharmacopoeia monograph is often referred to as a Sorafenib - Nexavar Certificate of Suitability (COS). The purpose of a Sorafenib - Nexavar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sorafenib - Nexavar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sorafenib - Nexavar to their clients by showing that a Sorafenib - Nexavar CEP has been issued for it. The manufacturer submits a Sorafenib - Nexavar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sorafenib - Nexavar CEP holder for the record. Additionally, the data presented in the Sorafenib - Nexavar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sorafenib - Nexavar DMF.
A Sorafenib - Nexavar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sorafenib - Nexavar 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 Sorafenib - Nexavar suppliers with CEP (COS) on PharmaCompass.
A Sorafenib - Nexavar written confirmation (Sorafenib - Nexavar WC) is an official document issued by a regulatory agency to a Sorafenib - Nexavar manufacturer, verifying that the manufacturing facility of a Sorafenib - Nexavar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sorafenib - Nexavar APIs or Sorafenib - Nexavar finished pharmaceutical products to another nation, regulatory agencies frequently require a Sorafenib - Nexavar WC (written confirmation) as part of the regulatory process.
click here to find a list of Sorafenib - Nexavar 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 Sorafenib - Nexavar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sorafenib - Nexavar 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 Sorafenib - Nexavar 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 Sorafenib - Nexavar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sorafenib - Nexavar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sorafenib - Nexavar suppliers with NDC on PharmaCompass.
Sorafenib - Nexavar 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 Sorafenib - Nexavar GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sorafenib - Nexavar GMP manufacturer or Sorafenib - Nexavar GMP API supplier for your needs.
A Sorafenib - Nexavar CoA (Certificate of Analysis) is a formal document that attests to Sorafenib - Nexavar's compliance with Sorafenib - Nexavar specifications and serves as a tool for batch-level quality control.
Sorafenib - Nexavar CoA mostly includes findings from lab analyses of a specific batch. For each Sorafenib - Nexavar 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.
Sorafenib - Nexavar may be tested according to a variety of international standards, such as European Pharmacopoeia (Sorafenib - Nexavar EP), Sorafenib - Nexavar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sorafenib - Nexavar USP).
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