KEY PRODUCTS
Indena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.
01 1Indena
01 1DOCETAXEL TRIHYDRATE
01 1Italy
01 1Active
01 1Complete
Indena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-09-26
DMF Number : 33209
Submission : 2018-09-28
Status : Active
Type : II
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Indena Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Indena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.
One of their notable products is DOCETAXEL TRIHYDRATE, with a corresponding US DMF Number 33209.
Remarkably, this DMF maintains an Active status since its submission on September 28, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 12, 2019, and payment made on September 26, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
