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01 1Olpha

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOlpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-17

Pay. Date : 2012-11-27

DMF Number : 15210

Submission : 2000-12-21

Status : Active

Type : II

Olpha

Looking for Drug Master Files (DMF) for 15210 of Olpha As

Looking for Drug Master Files (DMF) for 15210 of Olpha As 1

20

Olpha As, based in Latvia, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

One of their notable products is RIMANTADINE HYDROCHLORIDE, with a corresponding US DMF Number 15210.

Remarkably, this DMF maintains an Active status since its submission on December 21, 2000, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 17, 2014, and payment made on November 27, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II