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PharmaCompass offers a list of Diazepam 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 Diazepam manufacturer or Diazepam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diazepam manufacturer or Diazepam supplier.
PharmaCompass also assists you with knowing the Diazepam API Price utilized in the formulation of products. Diazepam API Price is not always fixed or binding as the Diazepam Price is obtained through a variety of data sources. The Diazepam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alupram manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alupram, including repackagers and relabelers. The FDA regulates Alupram manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alupram 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 Alupram manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alupram supplier is an individual or a company that provides Alupram active pharmaceutical ingredient (API) or Alupram finished formulations upon request. The Alupram suppliers may include Alupram API manufacturers, exporters, distributors and traders.
click here to find a list of Alupram suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alupram DMF (Drug Master File) is a document detailing the whole manufacturing process of Alupram active pharmaceutical ingredient (API) in detail. Different forms of Alupram DMFs exist exist since differing nations have different regulations, such as Alupram USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alupram DMF submitted to regulatory agencies in the US is known as a USDMF. Alupram USDMF includes data on Alupram's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alupram USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alupram suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Alupram Drug Master File in Japan (Alupram JDMF) empowers Alupram API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Alupram JDMF during the approval evaluation for pharmaceutical products. At the time of Alupram JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Alupram suppliers with JDMF on PharmaCompass.
A Alupram CEP of the European Pharmacopoeia monograph is often referred to as a Alupram Certificate of Suitability (COS). The purpose of a Alupram CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alupram EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alupram to their clients by showing that a Alupram CEP has been issued for it. The manufacturer submits a Alupram CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alupram CEP holder for the record. Additionally, the data presented in the Alupram CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alupram DMF.
A Alupram CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alupram 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 Alupram suppliers with CEP (COS) on PharmaCompass.
A Alupram written confirmation (Alupram WC) is an official document issued by a regulatory agency to a Alupram manufacturer, verifying that the manufacturing facility of a Alupram active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alupram APIs or Alupram finished pharmaceutical products to another nation, regulatory agencies frequently require a Alupram WC (written confirmation) as part of the regulatory process.
click here to find a list of Alupram 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 Alupram as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alupram 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 Alupram 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 Alupram and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alupram NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alupram suppliers with NDC on PharmaCompass.
Alupram 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 Alupram 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 Alupram GMP manufacturer or Alupram GMP API supplier for your needs.
A Alupram CoA (Certificate of Analysis) is a formal document that attests to Alupram's compliance with Alupram specifications and serves as a tool for batch-level quality control.
Alupram CoA mostly includes findings from lab analyses of a specific batch. For each Alupram 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.
Alupram may be tested according to a variety of international standards, such as European Pharmacopoeia (Alupram EP), Alupram JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alupram USP).