01 1Macleods Pharmaceuticals Limited
01 1ATORVASTATIN CALCIUM TRIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-14
Pay. Date : 2015-03-27
DMF Number : 28765
Submission : 2015-03-19
Status : Active
Type : II
20
Macleods Pharmaceuticals 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 ATORVASTATIN CALCIUM TRIHYDRATE, with a corresponding US DMF Number 28765.
Remarkably, this DMF maintains an Active status since its submission on March 19, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 14, 2015, and payment made on March 27, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
