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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)

08H Manufacturers

A 08H manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08H, including repackagers and relabelers. The FDA regulates 08H manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08H 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 08H manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

08H Suppliers

A 08H supplier is an individual or a company that provides 08H active pharmaceutical ingredient (API) or 08H finished formulations upon request. The 08H suppliers may include 08H API manufacturers, exporters, distributors and traders.

click here to find a list of 08H suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

08H USDMF

A 08H DMF (Drug Master File) is a document detailing the whole manufacturing process of 08H active pharmaceutical ingredient (API) in detail. Different forms of 08H DMFs exist exist since differing nations have different regulations, such as 08H USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 08H DMF submitted to regulatory agencies in the US is known as a USDMF. 08H USDMF includes data on 08H's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 08H USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 08H suppliers with USDMF on PharmaCompass.

08H 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 08H Drug Master File in Japan (08H JDMF) empowers 08H 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 08H JDMF during the approval evaluation for pharmaceutical products. At the time of 08H 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 08H suppliers with JDMF on PharmaCompass.

08H KDMF

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

Pharmaceutical companies submit a 08H Drug Master File in Korea (08H KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 08H. The MFDS reviews the 08H KDMF as part of the drug registration process and uses the information provided in the 08H KDMF to evaluate the safety and efficacy of the drug.

After submitting a 08H 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 08H API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 08H suppliers with KDMF on PharmaCompass.

08H CEP

A 08H CEP of the European Pharmacopoeia monograph is often referred to as a 08H Certificate of Suitability (COS). The purpose of a 08H CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 08H EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 08H to their clients by showing that a 08H CEP has been issued for it. The manufacturer submits a 08H CEP (COS) as part of the market authorization procedure, and it takes on the role of a 08H CEP holder for the record. Additionally, the data presented in the 08H CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 08H DMF.

A 08H CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 08H 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 08H suppliers with CEP (COS) on PharmaCompass.

08H WC

A 08H written confirmation (08H WC) is an official document issued by a regulatory agency to a 08H manufacturer, verifying that the manufacturing facility of a 08H active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 08H APIs or 08H finished pharmaceutical products to another nation, regulatory agencies frequently require a 08H WC (written confirmation) as part of the regulatory process.

click here to find a list of 08H suppliers with Written Confirmation (WC) on PharmaCompass.

08H 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 08H as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 08H 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 08H 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 08H and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 08H NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 08H suppliers with NDC on PharmaCompass.

08H GMP

08H 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 08H 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 08H GMP manufacturer or 08H GMP API supplier for your needs.

08H CoA

A 08H CoA (Certificate of Analysis) is a formal document that attests to 08H's compliance with 08H specifications and serves as a tool for batch-level quality control.

08H CoA mostly includes findings from lab analyses of a specific batch. For each 08H 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.

08H may be tested according to a variety of international standards, such as European Pharmacopoeia (08H EP), 08H JP (Japanese Pharmacopeia) and the US Pharmacopoeia (08H 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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