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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Isradipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isradipine, including repackagers and relabelers. The FDA regulates Isradipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isradipine 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 Isradipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isradipine supplier is an individual or a company that provides Isradipine active pharmaceutical ingredient (API) or Isradipine finished formulations upon request. The Isradipine suppliers may include Isradipine API manufacturers, exporters, distributors and traders.
click here to find a list of Isradipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isradipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Isradipine active pharmaceutical ingredient (API) in detail. Different forms of Isradipine DMFs exist exist since differing nations have different regulations, such as Isradipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isradipine DMF submitted to regulatory agencies in the US is known as a USDMF. Isradipine USDMF includes data on Isradipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isradipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isradipine suppliers with USDMF on PharmaCompass.
A Isradipine CEP of the European Pharmacopoeia monograph is often referred to as a Isradipine Certificate of Suitability (COS). The purpose of a Isradipine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isradipine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isradipine to their clients by showing that a Isradipine CEP has been issued for it. The manufacturer submits a Isradipine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isradipine CEP holder for the record. Additionally, the data presented in the Isradipine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isradipine DMF.
A Isradipine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isradipine 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 Isradipine suppliers with CEP (COS) on PharmaCompass.
A Isradipine written confirmation (Isradipine WC) is an official document issued by a regulatory agency to a Isradipine manufacturer, verifying that the manufacturing facility of a Isradipine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Isradipine APIs or Isradipine finished pharmaceutical products to another nation, regulatory agencies frequently require a Isradipine WC (written confirmation) as part of the regulatory process.
click here to find a list of Isradipine 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 Isradipine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Isradipine 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 Isradipine 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 Isradipine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isradipine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Isradipine suppliers with NDC on PharmaCompass.
Isradipine 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 Isradipine 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 Isradipine GMP manufacturer or Isradipine GMP API supplier for your needs.
A Isradipine CoA (Certificate of Analysis) is a formal document that attests to Isradipine's compliance with Isradipine specifications and serves as a tool for batch-level quality control.
Isradipine CoA mostly includes findings from lab analyses of a specific batch. For each Isradipine 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.
Isradipine may be tested according to a variety of international standards, such as European Pharmacopoeia (Isradipine EP), Isradipine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isradipine USP).
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