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US DMFs Filed
CEP/COS Certifications
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JDMFs Filed
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Other Certificates
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Other Suppliers
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USA (Orange Book)
Europe
Canada
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Australia
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South Africa
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Uploaded Dossiers
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U.S. Medicaid
Annual Reports
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PharmaCompass offers a list of Simeprevir 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 Simeprevir manufacturer or Simeprevir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Simeprevir manufacturer or Simeprevir supplier.
PharmaCompass also assists you with knowing the Simeprevir API Price utilized in the formulation of products. Simeprevir API Price is not always fixed or binding as the Simeprevir Price is obtained through a variety of data sources. The Simeprevir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Simeprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simeprevir, including repackagers and relabelers. The FDA regulates Simeprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simeprevir 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 Simeprevir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Simeprevir supplier is an individual or a company that provides Simeprevir active pharmaceutical ingredient (API) or Simeprevir finished formulations upon request. The Simeprevir suppliers may include Simeprevir API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Simeprevir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Simeprevir DMF (Drug Master File) is a document detailing the whole manufacturing process of Simeprevir active pharmaceutical ingredient (API) in detail. Different forms of Simeprevir DMFs exist exist since differing nations have different regulations, such as Simeprevir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Simeprevir DMF submitted to regulatory agencies in the US is known as a USDMF. Simeprevir USDMF includes data on Simeprevir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Simeprevir USDMF is kept confidential to protect the manufacturer’s intellectual property.
CLICK HERE to find a list of Simeprevir suppliers with USDMF on PharmaCompass.
Simeprevir 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 Simeprevir 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 Simeprevir GMP manufacturer or Simeprevir GMP API supplier for your needs.
A Simeprevir CoA (Certificate of Analysis) is a formal document that attests to Simeprevir's compliance with Simeprevir specifications and serves as a tool for batch-level quality control.
Simeprevir CoA mostly includes findings from lab analyses of a specific batch. For each Simeprevir 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.
Simeprevir may be tested according to a variety of international standards, such as European Pharmacopoeia (Simeprevir EP), Simeprevir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Simeprevir USP).