SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance

SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics

USFDA inspection at Piramal Pharma’s Bethlehem facility

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)

Zydus receives final approval from the USFDA for Clindamycin Phosphate Gel USP, 1%

Clindamycin Phosphate Gel is used to treat acne

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483

Strides receives tentative USFDA approval for Dolutegravir/Lamivudine/Tenofovir Disproxil Fumurate tablets

Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa

Zydus receives final approval from USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System

Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States

Strides receives tentative USFDA approval for Dolutegravir tablets

The products will be manufactured at the company's facility in Bengaluru

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations