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