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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 : 2023-05-29

Pay. Date : 2023-05-24

DMF Number : 16147

Submission : 2002-09-05

Status : Active

Type : II

Malladi

Looking for Drug Master Files (DMF) for 16147 of Malladi Drugs And Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 16147 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 D-PSEUDOEPHEDRINE SULFATE, with a corresponding US DMF Number 16147.

Remarkably, this DMF maintains an Active status since its submission on September 05, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 29, 2023, and payment made on May 24, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II