TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
KEY SERVICES
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01 1TAPI Technology & API Services
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01 1DABIGATRAN ETEXILATE MESYLATE
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01 1Israel
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01 1Active
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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 : 2014-07-15
Pay. Date : 2014-04-22
DMF Number : 28118
Submission : 2014-04-27
Status : Active
Type : II
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Tapi Nl Bv, 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 DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 28118.
Remarkably, this DMF maintains an Active status since its submission on April 27, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 15, 2014, and payment made on April 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II