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
01 3CABOZANTINIB (S)-MALATE
02 1CABOZANTINIB (S)-MALATE (FORM N-2)
03 1CABOZANTINIB (S)-MALATE (FORM-S)
04 1CABOZANTINIB HYDROCHLORIDE
05 1CABOZANTINIB INTERMEDIATE (CZT3)
06 1CABOZANTINIB SULFATE
07 1CABOZANTINIB-(S)-MALATE
08 1CABOZANTINIB-S-MALATE
01 2China
02 8India
01 10Active
01 5Complete
02 5Blank
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 : Active
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 : Active
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 : Active
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 : Active
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 : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-06
Pay. Date : 2023-03-08
DMF Number : 38057
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-25
Pay. Date : 2019-04-22
DMF Number : 33137
Submission : 2018-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-08
Pay. Date : 2017-05-22
DMF Number : 31522
Submission : 2017-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-23
Pay. Date : 2022-02-28
DMF Number : 36509
Submission : 2022-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-17
Pay. Date : 2019-10-11
DMF Number : 34201
Submission : 2019-11-06
Status : Active
Type : II
A Cabozantinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cabozantinib, including repackagers and relabelers. The FDA regulates Cabozantinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cabozantinib 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 Cabozantinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cabozantinib supplier is an individual or a company that provides Cabozantinib active pharmaceutical ingredient (API) or Cabozantinib finished formulations upon request. The Cabozantinib suppliers may include Cabozantinib API manufacturers, exporters, distributors and traders.
click here to find a list of Cabozantinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cabozantinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Cabozantinib active pharmaceutical ingredient (API) in detail. Different forms of Cabozantinib DMFs exist exist since differing nations have different regulations, such as Cabozantinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cabozantinib DMF submitted to regulatory agencies in the US is known as a USDMF. Cabozantinib USDMF includes data on Cabozantinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cabozantinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cabozantinib suppliers with USDMF on PharmaCompass.
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