01 1Hetero Drugs
01 1BUPROPION HYDROCHLORIDE (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-09
Pay. Date : 2014-05-22
DMF Number : 28297
Submission : 2014-06-04
Status : Active
Type : II
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Hetero Drugs 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 BUPROPION HYDROCHLORIDE (PROCESS-II), with a corresponding US DMF Number 28297.
Remarkably, this DMF maintains an Active status since its submission on June 04, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 09, 2014, and payment made on May 22, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
