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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
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01 6AFATINIB DIMALEATE
02 1AFATINIB DIMALEATE (FORM A)
03 1AFATINIB DIMALEATE MONOHYDRATE (FORM-R)
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01 1China
02 6India
03 1Israel
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01 7Active
02 1Inactive
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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 : 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 37111
Submission : 2022-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-17
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
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PharmaCompass offers a list of Afatinib 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 Afatinib manufacturer or Afatinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Afatinib manufacturer or Afatinib supplier.
PharmaCompass also assists you with knowing the Afatinib API Price utilized in the formulation of products. Afatinib API Price is not always fixed or binding as the Afatinib Price is obtained through a variety of data sources. The Afatinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Afatinib (diMaleate) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Afatinib (diMaleate), including repackagers and relabelers. The FDA regulates Afatinib (diMaleate) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Afatinib (diMaleate) 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 (diMaleate) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Afatinib (diMaleate) supplier is an individual or a company that provides Afatinib (diMaleate) active pharmaceutical ingredient (API) or Afatinib (diMaleate) finished formulations upon request. The Afatinib (diMaleate) suppliers may include Afatinib (diMaleate) API manufacturers, exporters, distributors and traders.
click here to find a list of Afatinib (diMaleate) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Afatinib (diMaleate) DMF (Drug Master File) is a document detailing the whole manufacturing process of Afatinib (diMaleate) active pharmaceutical ingredient (API) in detail. Different forms of Afatinib (diMaleate) DMFs exist exist since differing nations have different regulations, such as Afatinib (diMaleate) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Afatinib (diMaleate) DMF submitted to regulatory agencies in the US is known as a USDMF. Afatinib (diMaleate) USDMF includes data on Afatinib (diMaleate)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Afatinib (diMaleate) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Afatinib (diMaleate) suppliers with USDMF on PharmaCompass.
We have 7 companies offering Afatinib (diMaleate)
Get in contact with the supplier of your choice: