01 2MSN Laboratories
02 1Shilpa Medicare
03 1Synthon Pharmaceuticals
04 1Wisdom Pharmaceutical
05 1Zhejiang Jiuzhou Pharmaceutical
01 4AXITINIB
02 1AXITINIB (FORM-XLI)[ROUTE CODE - "XB"]
03 1AXITINIB [ROUTE CODE - "XA"]
01 2China
02 3India
03 1Netherlands
01 6Active
01 5Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-18
Pay. Date : 2015-09-23
DMF Number : 29672
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-16
Pay. Date : 2016-07-01
DMF Number : 30341
Submission : 2016-03-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-05
Pay. Date : 2015-12-23
DMF Number : 30104
Submission : 2015-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-27
Pay. Date : 2023-02-06
DMF Number : 37971
Submission : 2023-02-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39323
Submission : 2023-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-15
Pay. Date : 2015-10-29
DMF Number : 29918
Submission : 2015-10-10
Status : Active
Type : II
A Axitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Axitinib, including repackagers and relabelers. The FDA regulates Axitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Axitinib 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 Axitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Axitinib supplier is an individual or a company that provides Axitinib active pharmaceutical ingredient (API) or Axitinib finished formulations upon request. The Axitinib suppliers may include Axitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Axitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Axitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Axitinib active pharmaceutical ingredient (API) in detail. Different forms of Axitinib DMFs exist exist since differing nations have different regulations, such as Axitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Axitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Axitinib USDMF includes data on Axitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Axitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Axitinib suppliers with USDMF on PharmaCompass.
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