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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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 25MG **Federal Registe...DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12427
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12427
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PharmaCompass offers a list of Benzphetamine 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 Benzphetamine manufacturer or Benzphetamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Benzphetamine manufacturer or Benzphetamine supplier.
PharmaCompass also assists you with knowing the Benzphetamine API Price utilized in the formulation of products. Benzphetamine API Price is not always fixed or binding as the Benzphetamine Price is obtained through a variety of data sources. The Benzphetamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Didrex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Didrex, including repackagers and relabelers. The FDA regulates Didrex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Didrex 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 Didrex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Didrex supplier is an individual or a company that provides Didrex active pharmaceutical ingredient (API) or Didrex finished formulations upon request. The Didrex suppliers may include Didrex API manufacturers, exporters, distributors and traders.
click here to find a list of Didrex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Didrex DMF (Drug Master File) is a document detailing the whole manufacturing process of Didrex active pharmaceutical ingredient (API) in detail. Different forms of Didrex DMFs exist exist since differing nations have different regulations, such as Didrex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Didrex DMF submitted to regulatory agencies in the US is known as a USDMF. Didrex USDMF includes data on Didrex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Didrex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Didrex suppliers with USDMF on PharmaCompass.
A Didrex written confirmation (Didrex WC) is an official document issued by a regulatory agency to a Didrex manufacturer, verifying that the manufacturing facility of a Didrex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Didrex APIs or Didrex finished pharmaceutical products to another nation, regulatory agencies frequently require a Didrex WC (written confirmation) as part of the regulatory process.
click here to find a list of Didrex 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 Didrex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Didrex 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 Didrex 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 Didrex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Didrex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Didrex suppliers with NDC on PharmaCompass.
Didrex 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 Didrex 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 Didrex GMP manufacturer or Didrex GMP API supplier for your needs.
A Didrex CoA (Certificate of Analysis) is a formal document that attests to Didrex's compliance with Didrex specifications and serves as a tool for batch-level quality control.
Didrex CoA mostly includes findings from lab analyses of a specific batch. For each Didrex 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.
Didrex may be tested according to a variety of international standards, such as European Pharmacopoeia (Didrex EP), Didrex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Didrex USP).
