01 1Sterling Spa
01 1NORELGESTROMIN
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-19
Pay. Date : 2017-10-19
DMF Number : 18125
Submission : 2005-02-28
Status : Active
Type : II
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Sterling Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Global leader in steroidal APIs
One of their notable products is NORELGESTROMIN, with a corresponding US DMF Number 18125.
Remarkably, this DMF maintains an Active status since its submission on February 28, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 19, 2018, and payment made on October 19, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
