01 1Hetero Drugs
01 1ROSUVASTATIN CALCIUM (AMORPHOUS)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-25
Pay. Date : 2013-11-18
DMF Number : 27633
Submission : 2013-10-28
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 ROSUVASTATIN CALCIUM (AMORPHOUS), with a corresponding US DMF Number 27633.
Remarkably, this DMF maintains an Active status since its submission on October 28, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2014, and payment made on November 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
