Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
01 2Sichuan Elixir Pharmaceuticals
02 3Dr. Reddy's Laboratories
03 1Biocon
04 2MSN Laboratories
05 1Natco Pharma
06 1Sun Pharmaceutical Industries Limited
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39757
Submission : 2024-03-22
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38207
Submission : 2023-03-31
Status :
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39785
Submission : 2024-03-26
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39274
Submission : 2023-12-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39141
Submission : 2023-12-01
Status :
Type : II
A cabozantinib (S)-malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of cabozantinib (S)-malate, including repackagers and relabelers. The FDA regulates cabozantinib (S)-malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. cabozantinib (S)-malate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A cabozantinib (S)-malate DMF (Drug Master File) is a document detailing the whole manufacturing process of cabozantinib (S)-malate active pharmaceutical ingredient (API) in detail. Different forms of cabozantinib (S)-malate DMFs exist exist since differing nations have different regulations, such as cabozantinib (S)-malate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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