01 1Cdymax
01 1ERLOTINIB HYDROCHLORIDE [DRUG SUBSTANCE (NON-STERILE)]
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-25
Pay. Date : 2021-06-16
DMF Number : 36007
Submission : 2021-06-04
Status : Active
Type : II
20
Cdymax (india) Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is ERLOTINIB HYDROCHLORIDE [DRUG SUBSTANCE (NON-STERILE)], with a corresponding US DMF Number 36007.
Remarkably, this DMF maintains an Active status since its submission on June 04, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 25, 2021, and payment made on June 16, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
