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01 1TAPI Technology & API Services

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, 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 : 2016-08-11

Pay. Date : 2015-10-19

DMF Number : 5684

Submission : 1984-09-04

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 5684 of Teva Pharmaceutical Industries Ltd

Looking for Drug Master Files (DMF) for 5684 of Teva Pharmaceutical Industries Ltd 1

20

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 FLUOROMETHOLONE-17-ACETATE, with a corresponding US DMF Number 5684.

Remarkably, this DMF maintains an Active status since its submission on September 04, 1984, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 11, 2016, and payment made on October 19, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II