TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
01 1TAPI Technology & API Services
02 1Alembic Pharmaceuticals Limited
03 1Beijing Hope Pharmaceutical
04 1Cipla
05 1Esteve Huayi Pharmaceutical
06 1Fresenius Kabi Oncology Limited
07 1Hetero Drugs
08 4MSN Laboratories
09 1Natco Pharma
10 1ScinoPharm Taiwan, Ltd
11 1Shilpa Medicare
12 1Sun Pharmaceutical Industries Limited
13 2Wisdom Pharmaceutical
01 10IBRUTINIB
02 1IBRUTINIB (AMORPHOUS)
03 1IBRUTINIB (FORM C)
04 1IBRUTINIB (FORM S4)
05 2IBRUTINIB (FORM-A)
06 1IBRUTINIB (FORM-M5)
07 1IBRUTINIB (IBN)
01 4China
02 11India
03 1Israel
04 1Taiwan
01 15Active
02 2Inactive
01 9Complete
02 8Blank
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-05
Pay. Date : 2017-04-17
DMF Number : 31631
Submission : 2017-06-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-06-06
DMF Number : 32880
Submission : 2018-07-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2017-05-08
DMF Number : 31679
Submission : 2017-05-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-14
Pay. Date : 2017-08-14
DMF Number : 31689
Submission : 2017-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30759
Submission : 2016-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30557
Submission : 2016-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2016-09-22
DMF Number : 30925
Submission : 2016-12-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-02
Pay. Date : 2017-10-12
DMF Number : 32122
Submission : 2017-10-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-29
Pay. Date : 2017-03-27
DMF Number : 31547
Submission : 2017-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31917
Submission : 2017-07-20
Status : Active
Type : II
A Ibrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibrutinib, including repackagers and relabelers. The FDA regulates Ibrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibrutinib 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 Ibrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibrutinib supplier is an individual or a company that provides Ibrutinib active pharmaceutical ingredient (API) or Ibrutinib finished formulations upon request. The Ibrutinib suppliers may include Ibrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ibrutinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibrutinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibrutinib active pharmaceutical ingredient (API) in detail. Different forms of Ibrutinib DMFs exist exist since differing nations have different regulations, such as Ibrutinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibrutinib DMF submitted to regulatory agencies in the US is known as a USDMF. Ibrutinib USDMF includes data on Ibrutinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibrutinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibrutinib suppliers with USDMF on PharmaCompass.
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