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PharmaCompass

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Dr Reddys Laboratories Ltd

Country

USDMF

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AMWC Asia-TDAC
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Dr Reddys Laboratories Ltd

Country
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AMWC Asia-TDAC
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 43631

Submission : 2026-03-31

Status : Active

Type : II

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Looking for 2326521-71-3 / Adagrasib API manufacturers, exporters & distributors?

Adagrasib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Adagrasib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Adagrasib manufacturer or Adagrasib supplier for your needs.

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

API | Excipient name

Adagrasib

Synonyms

Mrtx849, 2326521-71-3, Mrtx-849, Adagrasib [usan], Kras g12c inhibitor mrtx849, 8eoo6hqf8y

Cas Number

2326521-71-3

Unique Ingredient Identifier (UNII)

8EOO6HQF8Y

About Adagrasib

Adagrasib is an orally available, small molecule inhibitor that targets the oncogenic KRAS substitution mutation, G12C, with potential antineoplastic activity. Upon oral administration adagrasib covalently binds to cytosine 12 within the switch II pocket of GDP-bound KRAS G12C, thereby inhibiting mutant KRAS-dependent signaling. KRAS, a member of the RAS family of oncogenes, serves an important role in cell signaling, division and differentiation. Mutations of KRAS may induce constitutive signal transduction leading to tumor cell growth, proliferation, invasion, and metastasis.

Adagrasib Manufacturers

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

Adagrasib Suppliers

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

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

Adagrasib USDMF

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

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

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

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.