01 1GLAND PHARMA LIMITED
01 1DIPHENHYDRAMINE HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-24
Pay. Date : 2021-08-13
DMF Number : 35953
Submission : 2021-06-30
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 DIPHENHYDRAMINE HYDROCHLORIDE, with a corresponding US DMF Number 35953.
Remarkably, this DMF maintains an Active status since its submission on June 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 24, 2021, and payment made on August 13, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
