Man Industries (India) bags Rs. 1,300 crore export order

Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores. The total order book of the company stands at approximately Rs. 2,000 crores to be executed in 6 to 8 months. This order reflects a robust business environment and showcases the trust of the customers they have in the company’s technological and executional capabilities.

Jeevan Scientific Technology announces successful completion of WHO inspection

The World Health Organization (WHO) conducted an inspection of Jeevan Scientific Technology Ltd's Bio-Analytical facility and Clinical Pharmacology Centre, Hyderabad. The purpose of the inspection was to review the BA/BE studies as well as the operations, systems and procedures. The inspectors have started the review on 14th March, 2023 and closed on 17th March, 2023.

The inspectors have closed the inspection with "No Critical Observations" as announced at the close out meeting. The inspectors have appreciated the strong Quality Management Systems (QMS) and highly skilled team of JSTL.

Unichem Laboratories receives ANDA approval for Ranolazine Extended-Release Tablets

Unichem Laboratories Limited has received ANDA approval for its Ranolazine Extended-Release Tablets, 500 mg and 1000 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Ranexa® (ranolazine extended-release tablets) 500 mg and 1000 mg, of Gilead Sciences Inc.

Ranolazine Extended-Release Tablets, 500 mg, and 1000 mg are indicated for the treatment of chronic angina. The product will be commercialized from Unichem's Goa Plant.

USFDA pre-approval inspection of oral oncology manufacturing facility, Gujarat

The USFDA conducted Pre-Approval Inspection [PAI] of Torrent Pharmaceuticals Ltd's Oral-Oncology manufacturing facility at Bileshwarpura, Gujarat from 13-Mar-23 to 17-Mar-23.

At the end of the inspection, the company has been issued a "Form 483" with 1 observation, which is procedural in nature. The company will respond to the USFDA within stipulated timeline and work closely with USFDA to address the observation at the earliest.