01 1Alembic Pharmaceuticals Limited
02 1Fresenius Kabi Oncology Limited
03 2Hetero Drugs
04 1MSN Laboratories
05 1Qilu Antibiotics Pharmaceutical Co., Ltd.
06 1Sun Pharmaceutical Industries Limited
07 1Teva Pharmaceutical Industries
01 6AFATINIB DIMALEATE
02 1AFATINIB DIMALEATE (FORM A)
03 1AFATINIB DIMALEATE MONOHYDRATE (FORM-R)
01 1China
02 6India
03 1Israel
01 7Active
02 1Inactive
01 6Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-27
DMF Number : 31848
Submission : 2017-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30927
Submission : 2016-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37111
Submission : 2022-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-30
Pay. Date : 2017-04-28
DMF Number : 31611
Submission : 2017-04-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-17
Pay. Date : 2017-03-24
DMF Number : 31285
Submission : 2016-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-21
Pay. Date : 2019-02-12
DMF Number : 33080
Submission : 2019-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-29
Pay. Date : 2017-04-28
DMF Number : 31515
Submission : 2017-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-28
Pay. Date : 2017-01-10
DMF Number : 31302
Submission : 2017-01-12
Status : Active
Type : II
A Afatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Afatinib, including repackagers and relabelers. The FDA regulates Afatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Afatinib 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 Afatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Afatinib supplier is an individual or a company that provides Afatinib active pharmaceutical ingredient (API) or Afatinib finished formulations upon request. The Afatinib suppliers may include Afatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Afatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Afatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Afatinib active pharmaceutical ingredient (API) in detail. Different forms of Afatinib DMFs exist exist since differing nations have different regulations, such as Afatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Afatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Afatinib USDMF includes data on Afatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Afatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Afatinib suppliers with USDMF on PharmaCompass.
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