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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 : 2014-03-06

Pay. Date : 2014-03-04

DMF Number : 16314

Submission : 2002-12-17

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 16314 of Flamma Spa

Looking for Drug Master Files (DMF) for 16314 of Flamma Spa 1

20

Flamma Spa, 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 LABETALOL HYDROCHLORIDE, with a corresponding US DMF Number 16314.

Remarkably, this DMF maintains an Active status since its submission on December 17, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 06, 2014, and payment made on March 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II