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01 1Noramco

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

GDUFA

DMF Review : Complete

Rev. Date : 2020-08-05

Pay. Date : 2020-07-30

DMF Number : 21084

Submission : 2008-01-23

Status : Active

Type : II

Noramco

Looking for Drug Master Files (DMF) for 21084 of Noramco Llc

Looking for Drug Master Files (DMF) for 21084 of Noramco Llc 1

20

Noramco Llc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

One of their notable products is TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE, with a corresponding US DMF Number 21084.

Remarkably, this DMF maintains an Active status since its submission on January 23, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 05, 2020, and payment made on July 30, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II