01 1Hy-Gro Chemicals
01 1DEXTROMETHORPHAN HYDROBROMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-23
Pay. Date : 2019-05-10
DMF Number : 33607
Submission : 2019-03-06
Status : Active
Type : II
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Hy-gro Chemicals Pharmtek Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is DEXTROMETHORPHAN HYDROBROMIDE, with a corresponding US DMF Number 33607.
Remarkably, this DMF maintains an Active status since its submission on March 06, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 23, 2019, and payment made on May 10, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
