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  • TABLET;ORAL - 150MG
  • TABLET;ORAL - 300MG
  • TABLET;ORAL - 75MG
  • TABLET;ORAL - 12.5MG;150MG
  • TABLET;ORAL - 12.5MG;300MG
  • TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 138402-11-6 / Irbesartan API manufacturers, exporters & distributors?

Irbesartan manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Irbesartan 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 Irbesartan manufacturer or Irbesartan supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Irbesartan manufacturer or Irbesartan supplier.

PharmaCompass also assists you with knowing the Irbesartan API Price utilized in the formulation of products. Irbesartan API Price is not always fixed or binding as the Irbesartan Price is obtained through a variety of data sources. The Irbesartan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Irbesartan

Synonyms

138402-11-6, Avapro, Aprovel, Karvea, Sr-47436, Bms-186295

Cas Number

138402-11-6

Unique Ingredient Identifier (UNII)

J0E2756Z7N

About Irbesartan

A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.

Irbesartan Hydrochlorothiazide Manufacturers

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

Irbesartan Hydrochlorothiazide Suppliers

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

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

Irbesartan Hydrochlorothiazide USDMF

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

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

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

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

Irbesartan Hydrochlorothiazide KDMF

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

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

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

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

Irbesartan Hydrochlorothiazide CEP

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

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

Irbesartan Hydrochlorothiazide WC

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

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

Irbesartan Hydrochlorothiazide 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 Irbesartan Hydrochlorothiazide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Irbesartan Hydrochlorothiazide GMP

Irbesartan Hydrochlorothiazide 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 Irbesartan Hydrochlorothiazide 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 Irbesartan Hydrochlorothiazide GMP manufacturer or Irbesartan Hydrochlorothiazide GMP API supplier for your needs.

Irbesartan Hydrochlorothiazide CoA

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

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

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