01 1Calyx Chemicals & Pharmaceuticals
01 1ERYTHROMYCIN STEARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-28
Pay. Date : 2016-10-14
DMF Number : 22061
Submission : 2008-10-06
Status : Active
Type : II
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Calyx Chemicals And Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is ERYTHROMYCIN STEARATE, with a corresponding US DMF Number 22061.
Remarkably, this DMF maintains an Active status since its submission on October 06, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 28, 2017, and payment made on October 14, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
