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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 : 2016-05-16

Pay. Date : 2016-04-10

DMF Number : 30454

Submission : 2016-04-20

Status : Active

Type : II

TAPI Company Banner

Looking for Drug Master Files (DMF) for 30454 of Tapi Nl Bv

Looking for Drug Master Files (DMF) for 30454 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 PACLITAXEL SEMISYNTHETIC (FROM 10-DAB), with a corresponding US DMF Number 30454.

Remarkably, this DMF maintains an Active status since its submission on April 20, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2016, and payment made on April 10, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II