Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
KEY PRODUCTS
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01 1Coral Drugs Private Limited
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01 1DEFLAZACORT
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01 1India
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-11-22
DMF Number : 38936
Submission : 2023-10-05
Status : Active
Type : II
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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 DEFLAZACORT, with a corresponding US DMF Number 38936.
Remarkably, this DMF maintains an Active status since its submission on October 05, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 20, 2023, and payment made on November 22, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II