Please Wait
Applying Filters...
Menu
Xls
Filters Filter
Cross PopUp
FILTER :

filter clear-filterReset all filters

01 1Coral Drugs Private Limited

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

filter clear-filterReset all filters

PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.

GDUFA

DMF Review : Complete

Rev. Date : 2019-11-14

Pay. Date : 2019-07-23

DMF Number : 31357

Submission : 2017-02-06

Status : Active

Type : II

Corel Drugs cGMP partner for APIs

Looking for Drug Master Files (DMF) for 31357 of Coral Drugs Private Ltd

Looking for Drug Master Files (DMF) for 31357 of Coral Drugs Private Ltd 1

20

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

They are recognized for Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.

One of their notable products is TRIAMCINOLONE ACETONIDE, with a corresponding US DMF Number 31357.

Remarkably, this DMF maintains an Active status since its submission on February 06, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2019, and payment made on July 23, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II