01 1Hetero Drugs
01 1SOTORASIB (FORM-III)
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41270
Submission : 2025-03-03
Status : Active
Type : II
33
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.
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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.
A AMG510 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMG510, including repackagers and relabelers. The FDA regulates AMG510 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMG510 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 AMG510 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AMG510 supplier is an individual or a company that provides AMG510 active pharmaceutical ingredient (API) or AMG510 finished formulations upon request. The AMG510 suppliers may include AMG510 API manufacturers, exporters, distributors and traders.
click here to find a list of AMG510 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AMG510 DMF (Drug Master File) is a document detailing the whole manufacturing process of AMG510 active pharmaceutical ingredient (API) in detail. Different forms of AMG510 DMFs exist exist since differing nations have different regulations, such as AMG510 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMG510 DMF submitted to regulatory agencies in the US is known as a USDMF. AMG510 USDMF includes data on AMG510's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMG510 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AMG510 suppliers with USDMF on PharmaCompass.
