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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 : 2017-07-18

Pay. Date : 2017-05-18

DMF Number : 31736

Submission : 2017-06-28

Status : Active

Type : II

TAPI Company Banner

Looking for Drug Master Files (DMF) for 31736 of Tapi Nl Bv

Looking for Drug Master Files (DMF) for 31736 of Tapi Nl Bv 1

20

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 SOFOSBUVIR 1213, with a corresponding US DMF Number 31736.

Remarkably, this DMF maintains an Active status since its submission on June 28, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 18, 2017, and payment made on May 18, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II