01 1Chemeca Drugs
01 1BUPROPION HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-03
Pay. Date : 2020-12-21
DMF Number : 35418
Submission : 2020-12-24
Status : Active
Type : II
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Chemeca Drugs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is BUPROPION HYDROCHLORIDE USP, with a corresponding US DMF Number 35418.
Remarkably, this DMF maintains an Active status since its submission on December 24, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 03, 2021, and payment made on December 21, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
