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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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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : CEP 2022-386 - Rev 00
Status : Valid
Issue Date : 2024-11-15
Type : Chemical
Substance Number : 2931
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...
Minakem is manufacturing small molecules APIs including corticosteroids
About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
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API Imports and Exports
Drugs in Development
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Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
N-Methyl-4-chloro-2-pyridinecarboxamide
CAS Number : 220000-87-3
End Use API : Sorafenib
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
CAS Number : 123-30-8
End Use API : Sorafenib
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
4-(4-Aminophenoxy)-N-methyl-2- pyridinecarboxamide
CAS Number : 284462-37-9
End Use API : Sorafenib
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
4-[4-[3-[4-Chloro-3- (trifluoromethyl)phenyl]ureid...
CAS Number : 284461-73-0
End Use API : Sorafenib
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
4-(4-Aminophenoxy)-N-methylpyridine-2-carboxamide
CAS Number : 284462-37-9
End Use API : Sorafenib
About The Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe ...
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Controlled & Modified Release
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Film Formers & Plasticizers
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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, Price,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.
PharmaCompass also assists you with knowing the Sorafenib API Price utilized in the formulation of products. Sorafenib API Price is not always fixed or binding as the Sorafenib Price is obtained through a variety of data sources. The Sorafenib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sorafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorafenib, including repackagers and relabelers. The FDA regulates Sorafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorafenib 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sorafenib supplier is an individual or a company that provides Sorafenib active pharmaceutical ingredient (API) or Sorafenib finished formulations upon request. The Sorafenib suppliers may include Sorafenib API manufacturers, exporters, distributors and traders.
click here to find a list of Sorafenib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sorafenib DMF (Drug Master File) is a document detailing the whole manufacturing process of Sorafenib active pharmaceutical ingredient (API) in detail. Different forms of Sorafenib DMFs exist exist since differing nations have different regulations, such as Sorafenib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sorafenib DMF submitted to regulatory agencies in the US is known as a USDMF. Sorafenib USDMF includes data on Sorafenib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sorafenib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sorafenib 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 Drug Master File in Japan (Sorafenib JDMF) empowers Sorafenib 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Sorafenib 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 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 Drug Master File in Korea (Sorafenib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sorafenib. The MFDS reviews the Sorafenib KDMF as part of the drug registration process and uses the information provided in the Sorafenib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sorafenib 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sorafenib suppliers with KDMF on PharmaCompass.
A Sorafenib CEP of the European Pharmacopoeia monograph is often referred to as a Sorafenib Certificate of Suitability (COS). The purpose of a Sorafenib CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sorafenib EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sorafenib to their clients by showing that a Sorafenib CEP has been issued for it. The manufacturer submits a Sorafenib CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sorafenib CEP holder for the record. Additionally, the data presented in the Sorafenib CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sorafenib DMF.
A Sorafenib CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sorafenib 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 suppliers with CEP (COS) on PharmaCompass.
A Sorafenib written confirmation (Sorafenib WC) is an official document issued by a regulatory agency to a Sorafenib manufacturer, verifying that the manufacturing facility of a Sorafenib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sorafenib APIs or Sorafenib finished pharmaceutical products to another nation, regulatory agencies frequently require a Sorafenib WC (written confirmation) as part of the regulatory process.
click here to find a list of Sorafenib 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sorafenib 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sorafenib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sorafenib suppliers with NDC on PharmaCompass.
Sorafenib 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 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 Sorafenib GMP manufacturer or Sorafenib GMP API supplier for your needs.
A Sorafenib CoA (Certificate of Analysis) is a formal document that attests to Sorafenib's compliance with Sorafenib specifications and serves as a tool for batch-level quality control.
Sorafenib CoA mostly includes findings from lab analyses of a specific batch. For each Sorafenib 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Sorafenib EP), Sorafenib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sorafenib USP).
