01 1Sai Life Sciences Limited
01 1IBUTILIDE FUMARATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-16
Pay. Date : 2015-09-08
DMF Number : 21470
Submission : 2008-03-08
Status : Active
Type : II
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Sai Life Sciences Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
They are recognized for Delivering Contract Development & Manufacturing Solutions, through a broad suite of expert capabilities across the molecular lifecycle
One of their notable products is IBUTILIDE FUMARATE USP, with a corresponding US DMF Number 21470.
Remarkably, this DMF maintains an Active status since its submission on March 08, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 16, 2015, and payment made on September 08, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
