Ipca Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is HYDROCHLOROTHIAZIDE USP, PROCESS II, with a corresponding US DMF Number 18563.
Remarkably, this DMF maintains an Active status since its submission on November 11, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2013, and payment made on July 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II