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API SUPPLIERS
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INTERMEDIATES SUPPLIERS
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Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]PMC Isochem
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
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ABOUT THIS PAGE
A Elbasvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elbasvir, including repackagers and relabelers. The FDA regulates Elbasvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elbasvir 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 Elbasvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elbasvir supplier is an individual or a company that provides Elbasvir active pharmaceutical ingredient (API) or Elbasvir finished formulations upon request. The Elbasvir suppliers may include Elbasvir API manufacturers, exporters, distributors and traders.
click here to find a list of Elbasvir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Elbasvir Drug Master File in Korea (Elbasvir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Elbasvir. The MFDS reviews the Elbasvir KDMF as part of the drug registration process and uses the information provided in the Elbasvir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Elbasvir 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 Elbasvir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Elbasvir suppliers with KDMF 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 Elbasvir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elbasvir 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 Elbasvir 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 Elbasvir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elbasvir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elbasvir suppliers with NDC on PharmaCompass.
Elbasvir 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 Elbasvir 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 Elbasvir GMP manufacturer or Elbasvir GMP API supplier for your needs.
A Elbasvir CoA (Certificate of Analysis) is a formal document that attests to Elbasvir's compliance with Elbasvir specifications and serves as a tool for batch-level quality control.
Elbasvir CoA mostly includes findings from lab analyses of a specific batch. For each Elbasvir 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.
Elbasvir may be tested according to a variety of international standards, such as European Pharmacopoeia (Elbasvir EP), Elbasvir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elbasvir USP).
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