Aurobindo Pharma gets USFDA nod for osteoporosis drug

New Delhi: Aurobindo Pharma has received final nod from the US health regulator to manufacture and market its generic Naproxen Sodium tablets used for the treatment of osteoporosis in postmenopausal women. “The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Naproxen Sodium tablets USP, 220 mg,” […]

Lupin Leads Selloff In Pharma Shares, Hits 52-Week Low

Lupin sank over 7 per cent on Friday to hit its 52-week low following a downgrade to “underperform” by global brokerage CLSA. The stock was the top Nifty loser. Lupin shares have been reeling under selling pressure following adverse observations about the company’s Goa plant by the US Food and Drug Administration earlier this week. […]

Glenmark Gets Tentative Nod From FDA For Epilepsy Drug

New Delhi: Glenmark Pharmaceuticals today said it has received tentative approval from the US health regulator for its generic version of Vimpat Oral Solution, used in treatment of epilepsy. “Glenmark Pharmaceuticals Inc, USA has been granted tentative approval by the US Food and Drug Administration (USFDA) for its Lacosamide Oral solution, 10 Mg/mL, the generic […]

Aurobindo Gets Final FDA Nod For Pre-Surgery Sedation Drug

New Delhi: Aurobindo Pharma has received final approval from the USFDA to manufacture and market pre-surgery sedation injections Dexmedetomidine Hydrochloride. “The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride Injection, 200 mcg (base)/2 mL (100 mcg (base)/mL) single-dose vials,” Aurobindo Pharma said in a […]

Torrent Pharma Gets Establishment Nod From USFDA

New Delhi: Drug firm Torrent Pharma today said its third manufacturing plant in Gujarat has obtained the Establishment Inspection Report ( EIR) from the US health regulator USFDA. “Torrent Pharma has successfully obtained the Establishment Inspection Report from the USFDA for its plant located at Dahej SEZ, in Gujarat… the plant has also received approval […]