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API SUPPLIERS
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
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USDMF
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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)...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
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SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Regorafenib 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 Regorafenib manufacturer or Regorafenib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Regorafenib manufacturer or Regorafenib supplier.
PharmaCompass also assists you with knowing the Regorafenib API Price utilized in the formulation of products. Regorafenib API Price is not always fixed or binding as the Regorafenib Price is obtained through a variety of data sources. The Regorafenib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Regorafenib Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regorafenib Monohydrate, including repackagers and relabelers. The FDA regulates Regorafenib Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regorafenib Monohydrate 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 Regorafenib Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Regorafenib Monohydrate supplier is an individual or a company that provides Regorafenib Monohydrate active pharmaceutical ingredient (API) or Regorafenib Monohydrate finished formulations upon request. The Regorafenib Monohydrate suppliers may include Regorafenib Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Regorafenib Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Regorafenib Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Regorafenib Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Regorafenib Monohydrate DMFs exist exist since differing nations have different regulations, such as Regorafenib Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Regorafenib Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Regorafenib Monohydrate USDMF includes data on Regorafenib Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Regorafenib Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Regorafenib Monohydrate suppliers with USDMF 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 Regorafenib Monohydrate Drug Master File in Korea (Regorafenib Monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Regorafenib Monohydrate. The MFDS reviews the Regorafenib Monohydrate KDMF as part of the drug registration process and uses the information provided in the Regorafenib Monohydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Regorafenib Monohydrate 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 Regorafenib Monohydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Regorafenib Monohydrate suppliers with KDMF on PharmaCompass.
A Regorafenib Monohydrate written confirmation (Regorafenib Monohydrate WC) is an official document issued by a regulatory agency to a Regorafenib Monohydrate manufacturer, verifying that the manufacturing facility of a Regorafenib Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Regorafenib Monohydrate APIs or Regorafenib Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Regorafenib Monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Regorafenib Monohydrate 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 Regorafenib Monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Regorafenib Monohydrate 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 Regorafenib Monohydrate 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 Regorafenib Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Regorafenib Monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Regorafenib Monohydrate suppliers with NDC on PharmaCompass.
Regorafenib Monohydrate 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 Regorafenib Monohydrate 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 Regorafenib Monohydrate GMP manufacturer or Regorafenib Monohydrate GMP API supplier for your needs.
A Regorafenib Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Regorafenib Monohydrate's compliance with Regorafenib Monohydrate specifications and serves as a tool for batch-level quality control.
Regorafenib Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Regorafenib Monohydrate 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.
Regorafenib Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Regorafenib Monohydrate EP), Regorafenib Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Regorafenib Monohydrate USP).
