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01 1EUROAPI

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-07

Pay. Date : 2013-02-25

DMF Number : 15890

Submission : 2002-03-08

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 15890 of Aventis Pharma Manufacturing Pte Ltd

Looking for Drug Master Files (DMF) for 15890 of Aventis Pharma Manufacturing Pte Ltd 1

20

Aventis Pharma Manufacturing Pte Ltd, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

One of their notable products is SODIUM CROMOGLICATE, with a corresponding US DMF Number 15890.

Remarkably, this DMF maintains an Active status since its submission on March 08, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2013, and payment made on February 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II