Torrent Pharma shares hit 52-week high; here's why
The USFDA conducted the pre-approval inspection at the company’s oral-oncology manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to December 11 last year.
The USFDA conducted the pre-approval inspection at the company’s oral-oncology manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to December 11 last year.
Aurobindo Pharma has received approval from USFDA to produce and trade Budesonide Inhalation Suspension
Warning letter stresses data integrity issues at company embedded with product complaints and microbial contamination
The OAI status may cause delay or withholding of pending product approvals or supplements from the facility, Biocon says
Strides Pharma Global Pte Limited, Singapore, which is a wholly-owned subsidiary of Strides Pharma, has received approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram, from the USFDA.
The share price of the drugmaker has risen 92% in the last one year from its 52-week low of ₹340.60 touched on July 27, 2022.
The pharma major received “zero observations” post the USFDA pre-approval inspection (PAI) and a routine GMP inspection at the Andhra Pradesh facility
The USFDA has allowed Zydus to manufacture and market Estradiol Transdermal System USP in the U.S; the drug will be produced at the group’s facility in Moraiya, Ahmedabad.
Indian pharma companies have increasingly de-risked their operations by slowly and steadily increasing sales to non-US markets, says India Ratings and Research.
USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved, says Cipla.