KEY PRODUCTS
Aspen API. More than just an API™
01 1Aspen API
01 1ROPIVACAINE HYDROCHLORIDE
01 1Netherlands
01 1Active
01 1Complete
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-19
Pay. Date : 2016-11-18
DMF Number : 20654
Submission : 2007-07-03
Status : Active
Type : II
20
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 ROPIVACAINE HYDROCHLORIDE, with a corresponding US DMF Number 20654.
Remarkably, this DMF maintains an Active status since its submission on July 03, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 19, 2016, and payment made on November 18, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
