01 1Hetero Drugs
01 1PITAVASTATIN CALCIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-07-10
DMF Number : 27255
Submission : 2013-07-16
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 PITAVASTATIN CALCIUM, with a corresponding US DMF Number 27255.
Remarkably, this DMF maintains an Active status since its submission on July 16, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 22, 2013, and payment made on July 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
