01 1Alembic Pharmaceuticals Limited
02 1Cdymax
03 1Cipla
04 1Hetero Drugs
05 2MSN Laboratories
06 1Natco Pharma
07 1Qilu Antibiotics Pharmaceutical Co., Ltd.
08 1SYNTHON Chemicals GmbH & Co. KG
09 1ScinoPharm Taiwan, Ltd
10 1Sichuan Xieli Pharmaceutical
11 1Yabao Pharmaceutical Group Co. Ltd
12 1Zhejiang Hisun Pharmaceutical
13 1Zhejiang Jiuzhou Pharmaceutical
01 13GEFITINIB
02 1GEFITINIB [ROUTE CODE GN]
01 5China
02 1Germany
03 7India
04 1Taiwan
01 13Active
02 1Inactive
01 9Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-13
Pay. Date : 2016-09-08
DMF Number : 30868
Submission : 2016-09-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-09-13
DMF Number : 29090
Submission : 2015-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-23
Pay. Date : 2018-01-04
DMF Number : 32274
Submission : 2017-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-25
Pay. Date : 2016-09-30
DMF Number : 29670
Submission : 2015-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-11
Pay. Date : 2015-09-24
DMF Number : 29772
Submission : 2015-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31941
Submission : 2017-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-05
Pay. Date : 2015-12-23
DMF Number : 26456
Submission : 2012-09-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-27
Pay. Date : 2015-11-19
DMF Number : 29797
Submission : 2015-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28613
Submission : 2014-09-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-28
Pay. Date : 2016-06-15
DMF Number : 30518
Submission : 2016-04-28
Status : Active
Type : II
A Gefitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gefitinib, including repackagers and relabelers. The FDA regulates Gefitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gefitinib 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 Gefitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gefitinib supplier is an individual or a company that provides Gefitinib active pharmaceutical ingredient (API) or Gefitinib finished formulations upon request. The Gefitinib suppliers may include Gefitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Gefitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gefitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Gefitinib active pharmaceutical ingredient (API) in detail. Different forms of Gefitinib DMFs exist exist since differing nations have different regulations, such as Gefitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gefitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Gefitinib USDMF includes data on Gefitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gefitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gefitinib suppliers with USDMF on PharmaCompass.
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