KEY PRODUCTS
Aspen API. More than just an API™
01 1Aspen API
01 1REMIFENTANIL HYDROCHLORIDE
01 1Netherlands
01 1Active
01 1Complete
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-30
Pay. Date : 2014-12-04
DMF Number : 28106
Submission : 2014-03-13
Status : Active
Type : II
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Fine Chemicals Corp Pty Ltd, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Aspen API. More than just an API™
One of their notable products is REMIFENTANIL HYDROCHLORIDE, with a corresponding US DMF Number 28106.
Remarkably, this DMF maintains an Active status since its submission on March 13, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2015, and payment made on December 04, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
