KEY PRODUCTS
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
01 1Coral Drugs Private Limited
01 1AZELASTINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-01
Pay. Date : 2023-09-22
DMF Number : 36205
Submission : 2021-10-09
Status : Active
Type : II
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 AZELASTINE HYDROCHLORIDE USP, with a corresponding US DMF Number 36205.
Remarkably, this DMF maintains an Active status since its submission on October 09, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 01, 2023, and payment made on September 22, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
