KEY SERVICES
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
01 1NILOTINIB HYDROCHLORIDE FORM ALPHA
01 1Israel
01 1Active
01 1Complete
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 : 2020-08-28
Pay. Date : 2020-05-13
DMF Number : 34874
Submission : 2020-07-14
Status : Active
Type : II
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Teva Pharmaceutical Industries Ltd, based in Israel, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
One of their notable products is NILOTINIB HYDROCHLORIDE FORM ALPHA, with a corresponding US DMF Number 34874.
Remarkably, this DMF maintains an Active status since its submission on July 14, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 28, 2020, and payment made on May 13, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
