01 1Hetero Drugs
01 1CINACALCET HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-05-03
DMF Number : 29399
Submission : 2015-05-19
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 CINACALCET HYDROCHLORIDE, with a corresponding US DMF Number 29399.
Remarkably, this DMF maintains an Active status since its submission on May 19, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 06, 2016, and payment made on May 03, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
