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01 1Fermion Oy
02 1Veranova
03 1BDR Lifesciences
04 1CHEMO IBERICA SA
05 1Cipla
06 2Formosa Laboratories
07 1Glenmark Life Sciences
08 1Hansoh Pharma
09 1Hetero Drugs
10 1Hubei Gedian Humanwell Pharmaceutical
11 2MSN Laboratories
12 1Macleods Pharmaceuticals Limited
13 2Olon S.p.A
14 1Shandong Anhong Pharmaceutical
15 1Sichuan Kelun Pharmaceutical
16 1Sun Pharmaceutical Industries Limited
17 1Teva Pharmaceutical Industries
01 2NINTEDANIB
02 1NINTEDANIB BASE
03 15NINTEDANIB ESYLATE
04 1NINTEDANIB ESYLATE HEMIHYDRATE
05 1NINTEDANIB ESYLATE, NON-STERILE, BULK DRUG SUBSTANCE
01 4China
02 1Finland
03 8India
04 1Israel
05 2Italy
06 1Spain
07 2Taiwan
08 1U.S.A
01 20Active
01 14Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-26
Pay. Date : 2018-12-20
DMF Number : 33361
Submission : 2019-01-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-27
Pay. Date : 2018-03-30
DMF Number : 32511
Submission : 2018-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-05
Pay. Date : 2018-03-19
DMF Number : 32504
Submission : 2018-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32408
Submission : 2018-01-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-09
Pay. Date : 2018-04-24
DMF Number : 32643
Submission : 2018-04-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-05
Pay. Date : 2019-10-10
DMF Number : 32152
Submission : 2017-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-03
Pay. Date : 2018-09-20
DMF Number : 33152
Submission : 2018-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-03-07
DMF Number : 31526
Submission : 2017-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32529
Submission : 2018-02-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-29
Pay. Date : 2018-06-04
DMF Number : 32866
Submission : 2018-08-03
Status : Active
Type : II
A Nintedanib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nintedanib, including repackagers and relabelers. The FDA regulates Nintedanib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nintedanib 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 Nintedanib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nintedanib supplier is an individual or a company that provides Nintedanib active pharmaceutical ingredient (API) or Nintedanib finished formulations upon request. The Nintedanib suppliers may include Nintedanib API manufacturers, exporters, distributors and traders.
click here to find a list of Nintedanib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nintedanib DMF (Drug Master File) is a document detailing the whole manufacturing process of Nintedanib active pharmaceutical ingredient (API) in detail. Different forms of Nintedanib DMFs exist exist since differing nations have different regulations, such as Nintedanib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nintedanib DMF submitted to regulatory agencies in the US is known as a USDMF. Nintedanib USDMF includes data on Nintedanib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nintedanib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nintedanib suppliers with USDMF on PharmaCompass.
We have 17 companies offering Nintedanib
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