KEY PRODUCTS
Maithri Drugs: Dedicated to your API needs.
01 1Maithri Drugs
01 1AVACOPAN
01 1India
01 1Active
01 1Complete
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-25
Pay. Date : 2025-05-20
DMF Number : 40159
Submission : 2024-06-29
Status : Active
Type : II
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Maithri Drugs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Maithri Drugs: Dedicated to your API needs.
One of their notable products is AVACOPAN, with a corresponding US DMF Number 40159.
Remarkably, this DMF maintains an Active status since its submission on June 29, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 25, 2025, and payment made on May 20, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
