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  • TABLET;ORAL - 0.25MG
  • TABLET;ORAL - 0.5MG
  • TABLET;ORAL - 1MG
  • TABLET;ORAL - 2MG
  • TABLET, EXTENDED RELEASE;ORAL - 0.5MG
  • TABLET, EXTENDED RELEASE;ORAL - 1MG
  • TABLET, EXTENDED RELEASE;ORAL - 2MG
  • TABLET, EXTENDED RELEASE;ORAL - 3MG

Looking for 28981-97-7 / Alprazolam API manufacturers, exporters & distributors?

Alprazolam manufacturers, exporters & distributors 1

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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.

API | Excipient name

Alprazolam

Synonyms

Xanax, 28981-97-7, Trankimazin, Niravam, Tafil, Tranquinal

Cas Number

28981-97-7

Unique Ingredient Identifier (UNII)

YU55MQ3IZY

About Alprazolam

A triazolobenzodiazepine compound with antianxiety and sedative-hypnotic actions, that is efficacious in the treatment of PANIC DISORDERS, with or without AGORAPHOBIA, and in generalized ANXIETY DISORDERS. (From AMA Drug Evaluations Annual, 1994, p238)

Alzolam Manufacturers

A Alzolam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alzolam, including repackagers and relabelers. The FDA regulates Alzolam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alzolam 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 Alzolam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Alzolam Suppliers

A Alzolam supplier is an individual or a company that provides Alzolam active pharmaceutical ingredient (API) or Alzolam finished formulations upon request. The Alzolam suppliers may include Alzolam API manufacturers, exporters, distributors and traders.

click here to find a list of Alzolam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Alzolam USDMF

A Alzolam DMF (Drug Master File) is a document detailing the whole manufacturing process of Alzolam active pharmaceutical ingredient (API) in detail. Different forms of Alzolam DMFs exist exist since differing nations have different regulations, such as Alzolam USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Alzolam DMF submitted to regulatory agencies in the US is known as a USDMF. Alzolam USDMF includes data on Alzolam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alzolam USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Alzolam suppliers with USDMF on PharmaCompass.

Alzolam JDMF

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 Alzolam Drug Master File in Japan (Alzolam JDMF) empowers Alzolam 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 Alzolam JDMF during the approval evaluation for pharmaceutical products. At the time of Alzolam 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 Alzolam suppliers with JDMF on PharmaCompass.

Alzolam KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Alzolam Drug Master File in Korea (Alzolam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alzolam. The MFDS reviews the Alzolam KDMF as part of the drug registration process and uses the information provided in the Alzolam KDMF to evaluate the safety and efficacy of the drug.

After submitting a Alzolam 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 Alzolam API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Alzolam suppliers with KDMF on PharmaCompass.

Alzolam CEP

A Alzolam CEP of the European Pharmacopoeia monograph is often referred to as a Alzolam Certificate of Suitability (COS). The purpose of a Alzolam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alzolam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alzolam to their clients by showing that a Alzolam CEP has been issued for it. The manufacturer submits a Alzolam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alzolam CEP holder for the record. Additionally, the data presented in the Alzolam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alzolam DMF.

A Alzolam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alzolam 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 Alzolam suppliers with CEP (COS) on PharmaCompass.

Alzolam WC

A Alzolam written confirmation (Alzolam WC) is an official document issued by a regulatory agency to a Alzolam manufacturer, verifying that the manufacturing facility of a Alzolam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alzolam APIs or Alzolam finished pharmaceutical products to another nation, regulatory agencies frequently require a Alzolam WC (written confirmation) as part of the regulatory process.

click here to find a list of Alzolam suppliers with Written Confirmation (WC) on PharmaCompass.

Alzolam NDC

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 Alzolam as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Alzolam API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Alzolam 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Alzolam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alzolam NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Alzolam suppliers with NDC on PharmaCompass.

Alzolam GMP

Alzolam 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 Alzolam 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 Alzolam GMP manufacturer or Alzolam GMP API supplier for your needs.

Alzolam CoA

A Alzolam CoA (Certificate of Analysis) is a formal document that attests to Alzolam's compliance with Alzolam specifications and serves as a tool for batch-level quality control.

Alzolam CoA mostly includes findings from lab analyses of a specific batch. For each Alzolam 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.

Alzolam may be tested according to a variety of international standards, such as European Pharmacopoeia (Alzolam EP), Alzolam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alzolam USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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