01 1GLAND PHARMA LIMITED
01 1PROCAINAMIDE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-04
Pay. Date : 2021-10-27
DMF Number : 36402
Submission : 2021-10-30
Status : Active
Type : II
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Gland Pharma Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is PROCAINAMIDE HYDROCHLORIDE, with a corresponding US DMF Number 36402.
Remarkably, this DMF maintains an Active status since its submission on October 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 04, 2022, and payment made on October 27, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
