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PharmaCompass offers a list of Alprazolam 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 Alprazolam manufacturer or Alprazolam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alprazolam manufacturer or Alprazolam supplier.
PharmaCompass also assists you with knowing the Alprazolam API Price utilized in the formulation of products. Alprazolam API Price is not always fixed or binding as the Alprazolam Price is obtained through a variety of data sources. The Alprazolam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alprazolam extended release tablets manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprazolam extended release tablets, including repackagers and relabelers. The FDA regulates Alprazolam extended release tablets manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprazolam extended release tablets 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 Alprazolam extended release tablets manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprazolam extended release tablets supplier is an individual or a company that provides Alprazolam extended release tablets active pharmaceutical ingredient (API) or Alprazolam extended release tablets finished formulations upon request. The Alprazolam extended release tablets suppliers may include Alprazolam extended release tablets API manufacturers, exporters, distributors and traders.
click here to find a list of Alprazolam extended release tablets suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alprazolam extended release tablets DMF (Drug Master File) is a document detailing the whole manufacturing process of Alprazolam extended release tablets active pharmaceutical ingredient (API) in detail. Different forms of Alprazolam extended release tablets DMFs exist exist since differing nations have different regulations, such as Alprazolam extended release tablets USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alprazolam extended release tablets DMF submitted to regulatory agencies in the US is known as a USDMF. Alprazolam extended release tablets USDMF includes data on Alprazolam extended release tablets's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alprazolam extended release tablets USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alprazolam extended release tablets 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 Alprazolam extended release tablets Drug Master File in Japan (Alprazolam extended release tablets JDMF) empowers Alprazolam extended release tablets 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 Alprazolam extended release tablets JDMF during the approval evaluation for pharmaceutical products. At the time of Alprazolam extended release tablets 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 Alprazolam extended release tablets suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Alprazolam extended release tablets Drug Master File in Korea (Alprazolam extended release tablets KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alprazolam extended release tablets. The MFDS reviews the Alprazolam extended release tablets KDMF as part of the drug registration process and uses the information provided in the Alprazolam extended release tablets KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alprazolam extended release tablets KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Alprazolam extended release tablets API can apply through the Korea Drug Master File (KDMF).
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A Alprazolam extended release tablets CEP of the European Pharmacopoeia monograph is often referred to as a Alprazolam extended release tablets Certificate of Suitability (COS). The purpose of a Alprazolam extended release tablets CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alprazolam extended release tablets EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alprazolam extended release tablets to their clients by showing that a Alprazolam extended release tablets CEP has been issued for it. The manufacturer submits a Alprazolam extended release tablets CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alprazolam extended release tablets CEP holder for the record. Additionally, the data presented in the Alprazolam extended release tablets CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alprazolam extended release tablets DMF.
A Alprazolam extended release tablets CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alprazolam extended release tablets CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Alprazolam extended release tablets written confirmation (Alprazolam extended release tablets WC) is an official document issued by a regulatory agency to a Alprazolam extended release tablets manufacturer, verifying that the manufacturing facility of a Alprazolam extended release tablets active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alprazolam extended release tablets APIs or Alprazolam extended release tablets finished pharmaceutical products to another nation, regulatory agencies frequently require a Alprazolam extended release tablets WC (written confirmation) as part of the regulatory process.
click here to find a list of Alprazolam extended release tablets 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 Alprazolam extended release tablets as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alprazolam extended release tablets 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 Alprazolam extended release tablets 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 Alprazolam extended release tablets and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alprazolam extended release tablets NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alprazolam extended release tablets suppliers with NDC on PharmaCompass.
Alprazolam extended release tablets 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 Alprazolam extended release tablets 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 Alprazolam extended release tablets GMP manufacturer or Alprazolam extended release tablets GMP API supplier for your needs.
A Alprazolam extended release tablets CoA (Certificate of Analysis) is a formal document that attests to Alprazolam extended release tablets's compliance with Alprazolam extended release tablets specifications and serves as a tool for batch-level quality control.
Alprazolam extended release tablets CoA mostly includes findings from lab analyses of a specific batch. For each Alprazolam extended release tablets 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.
Alprazolam extended release tablets may be tested according to a variety of international standards, such as European Pharmacopoeia (Alprazolam extended release tablets EP), Alprazolam extended release tablets JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alprazolam extended release tablets USP).
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