01 1Solara Active Pharma Sciences
01 1ZILEUTON USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-14
Pay. Date : 2018-09-27
DMF Number : 31578
Submission : 2017-07-29
Status : Active
Type : II
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Solara Active Pharma Sciences Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for API Expertise for more than 30 Years, with 4 Manufacturing Facilities armed with Global Approvals.
One of their notable products is ZILEUTON USP, with a corresponding US DMF Number 31578.
Remarkably, this DMF maintains an Active status since its submission on July 29, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2018, and payment made on September 27, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
