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Looking for 2296729-00-3 / Sotorasib API manufacturers, exporters & distributors?

Sotorasib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sotorasib

Synonyms

Amg-510, Amg510, 2296729-00-3, Lumakras, Amg-510 racemate, Amg 510

Cas Number

2296729-00-3

Unique Ingredient Identifier (UNII)

2B2VM6UC8G

About Sotorasib

Sotorasib is an orally available inhibitor of the specific KRAS mutation, p.G12C, with potential antineoplastic activity. Upon oral administration, sotorasib selectively targets, binds to and inhibits the activity of the KRAS p.G12C mutant. This may inhibit growth in KRAS p.G12C-expressing tumor cells. The KRAS p.G12C mutation is seen in some tumor cell types and plays a key role in tumor cell proliferation.

Sotorasib Manufacturers

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

Sotorasib Suppliers

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

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

Sotorasib 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 Sotorasib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sotorasib GMP

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

Sotorasib CoA

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

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

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