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01 1Malladi Drugs & Pharmaceuticals Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

GDUFA

DMF Review : Complete

Rev. Date : 2023-07-17

Pay. Date : 2023-07-13

DMF Number : 20448

Submission : 2007-04-10

Status : Active

Type : II

Malladi

Looking for Drug Master Files (DMF) for 20448 of Malladi Drugs And Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 20448 of Malladi Drugs And Pharmaceuticals Ltd 1

20

Malladi Drugs And Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

One of their notable products is ALPRAZOLAM, with a corresponding US DMF Number 20448.

Remarkably, this DMF maintains an Active status since its submission on April 10, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 17, 2023, and payment made on July 13, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II