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Looking for 1413431-07-8 / Deutivacaftor API manufacturers, exporters & distributors?

Deutivacaftor manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Deutivacaftor

Synonyms

D9-ivacaftor, Ivacaftor d9, Ivacaftor-d9, Sha6u5fjzl, 1413431-07-8, Deutivacaftor [usan]

Cas Number

1413431-07-8

Unique Ingredient Identifier (UNII)

SHA6U5FJZL

About Deutivacaftor

Deutivacaftor is under investigation in clinical trial NCT03227471 (A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis).

Deutivacaftor Manufacturers

A Deutivacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deutivacaftor, including repackagers and relabelers. The FDA regulates Deutivacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deutivacaftor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Deutivacaftor Suppliers

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

Deutivacaftor 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 Deutivacaftor as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Deutivacaftor GMP

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

Deutivacaftor CoA

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

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

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