KEY PRODUCTS
Aspen API. More than just an API™
01 1Aspen API
01 1SCOPOLAMINE (HYOSCINE)
01 1Netherlands
01 1Active
01 1Complete
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-30
Pay. Date : 2019-05-24
DMF Number : 25316
Submission : 2011-09-22
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 SCOPOLAMINE (HYOSCINE), with a corresponding US DMF Number 25316.
Remarkably, this DMF maintains an Active status since its submission on September 22, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2019, and payment made on May 24, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
