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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]Related Excipient Companies
Faran Shimi Pharmaceutical
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Olsalazine 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 Olsalazine manufacturer or Olsalazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Olsalazine manufacturer or Olsalazine supplier.
PharmaCompass also assists you with knowing the Olsalazine API Price utilized in the formulation of products. Olsalazine API Price is not always fixed or binding as the Olsalazine Price is obtained through a variety of data sources. The Olsalazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dipentum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dipentum, including repackagers and relabelers. The FDA regulates Dipentum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dipentum 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 Dipentum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dipentum supplier is an individual or a company that provides Dipentum active pharmaceutical ingredient (API) or Dipentum finished formulations upon request. The Dipentum suppliers may include Dipentum API manufacturers, exporters, distributors and traders.
click here to find a list of Dipentum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dipentum DMF (Drug Master File) is a document detailing the whole manufacturing process of Dipentum active pharmaceutical ingredient (API) in detail. Different forms of Dipentum DMFs exist exist since differing nations have different regulations, such as Dipentum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dipentum DMF submitted to regulatory agencies in the US is known as a USDMF. Dipentum USDMF includes data on Dipentum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dipentum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dipentum suppliers with USDMF on PharmaCompass.
A Dipentum written confirmation (Dipentum WC) is an official document issued by a regulatory agency to a Dipentum manufacturer, verifying that the manufacturing facility of a Dipentum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dipentum APIs or Dipentum finished pharmaceutical products to another nation, regulatory agencies frequently require a Dipentum WC (written confirmation) as part of the regulatory process.
click here to find a list of Dipentum 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 Dipentum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dipentum 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 Dipentum 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 Dipentum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dipentum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dipentum suppliers with NDC on PharmaCompass.
Dipentum 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 Dipentum 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 Dipentum GMP manufacturer or Dipentum GMP API supplier for your needs.
A Dipentum CoA (Certificate of Analysis) is a formal document that attests to Dipentum's compliance with Dipentum specifications and serves as a tool for batch-level quality control.
Dipentum CoA mostly includes findings from lab analyses of a specific batch. For each Dipentum 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.
Dipentum may be tested according to a variety of international standards, such as European Pharmacopoeia (Dipentum EP), Dipentum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dipentum USP).
