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Looking for 1257044-40-8 / Venetoclax API manufacturers, exporters & distributors?

Venetoclax manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Venetoclax

Synonyms

1257044-40-8, Abt-199, Venclexta, Gdc-0199, Abt199, Abt 199

Cas Number

1257044-40-8

Unique Ingredient Identifier (UNII)

N54AIC43PW

About Venetoclax

Venetoclax is an orally bioavailable, selective small molecule inhibitor of the anti-apoptotic protein Bcl-2, with potential antineoplastic activity. Venetoclax mimics BH3-only proteins, the native ligands of Bcl-2 and apoptosis activators, by binding to the hydrophobic groove of Bcl-2 proteins thereby repressing Bcl-2 activity and restoring apoptotic processes in tumor cells. Bcl-2 protein is overexpressed in some cancers and plays an important role in the regulation of apoptosis; its expression is associated with increased drug resistance and tumor cell survival. Compared to the Bcl-2 inhibitor navitoclax, this agent does not inhibit bcl-XL and does not cause bcl-XL-mediated thrombocytopenia.

Venetoclax Manufacturers

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

Venetoclax Suppliers

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

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

Venetoclax USDMF

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

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

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

Venetoclax KDMF

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

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

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

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

Venetoclax WC

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

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

Venetoclax 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 Venetoclax as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Venetoclax GMP

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

Venetoclax CoA

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

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

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