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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)

Alprazolam Manufacturers

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

Alprazolam Suppliers

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

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

Alprazolam USDMF

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

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

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

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

Alprazolam KDMF

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

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

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

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

Alprazolam CEP

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

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

Alprazolam WC

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

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

Alprazolam 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 Alprazolam as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Alprazolam GMP

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

Alprazolam CoA

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

Alprazolam CoA mostly includes findings from lab analyses of a specific batch. For each Alprazolam 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Alprazolam EP), Alprazolam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alprazolam 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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