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USFDA clears Lupin's Goa facility; stocks up 6.25%

USFDA clears Lupin's Goa facility; stocks up 6.25%

Pharma firm Lupin has received Establishment Inspection Report (EIR) from the US health regulator for its Goa facility regarding a inspection done by the USFDA in July last year.

Zydus Cadila gets USFDA's final nod for fungal treatment drug

The Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Voriconazole tablets in strengths of 50 and 200 mg, Cadila Healhtcare said in a BSE filing.

Are e-cigarettes beneficial or cause harm? This is what experts say!

The team also warned that heavy regulation and taxation of e-cigarettes will counteract the benefit that these products can provide.

Sun Pharma gets USFDA nod for eye inflammation drug

The company is likely to commercialise BromSite through its newly formed US-based division Sun Ophthalmics in the second half of 2016.

Ipca shares down 14% at 52-week low on fallout of USFDA warning

The shares of Ipca Laboratories slumped over 14 percent as Switzerland-based Global Fund, which financially supports various disease eradication programmes, decided it will not source its malaria drug, the company notified the BSE.

USFDA actions hurting exports, need govt intervention: Dr Reddy's

USFDA actions hurting exports, need govt intervention: Dr Reddy's

Asserting that regulatory action by the US Food and Drug Administration (USFDA) on leading Indian firms has impacted exports from the country, Dr Reddy's Laboratories Chairman Satish Reddy Wednesday asked for a dialogue between government and US health regulator.

Lupin launches generic Aricept tablets in US market

Lupin launches generic Aricept tablets in US market

Drug major Lupin has launched Donepezil Hydrochloride tablets, used in treating Alzheimer's disease, in the US market after having received the US health regulator USFDA's nod for the product earlier

Natco Pharma shares extend fall; down 5% on USFDA observations

Natco Pharma shares extend fall; down 5% on USFDA observations

 Continuing to fall for the second consecutive day, shares of Natco Pharma fell by nearly 5 percent today, after the company received 483 observations from the USFDA after inspection of its two facilities.

Aurobindo Pharma climbs after USFDA nod for OTC drug

Shares of Aurobindo Pharma surged over 2 percent today after the firm got final approval from USFDA to manufacture and market its generic Naproxen Sodium tablets used for treatment of osteoporosis.

Aurobindo Pharma gets USFDA nod for osteoporosis drug

Aurobindo Pharma gets USFDA nod for osteoporosis drug

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 wome

Lupin receives nine observations from USFDA for Goa plant

Drug major Lupin on Tuesday says that it has received nine observations relating to inadequacy and adherence to operating norms for its manufacturing plant in Goa from the US Food and Drug Administration (USFDA)

Glenmark gets USFDA final nod for anti-bacterial drug

Glenmark Pharmaceuticals has received the final nod from the US health regulator for a generic version of anti-bacterial drug Zyvox.

Sun Pharma shares slump 7.5% on warning letter from USFDA

Sun Pharma shares slump 7.5% on warning letter from USFDA

Shares of Sun Pharmaceutical slumped 7.5 percent Monday as the company has received a warning letter from the USFDA over violation of manufacturing norms at its facility at Halol in Gujarat.

Sun Pharma gets warning letter from USFDA over Halol unit

Sun Pharma gets warning letter from USFDA over Halol unit

Drug major Sun Pharmaceutical Industries on Saturday said it has received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat.

Aurobindo gets USFDA nod to market generic Osteoporosis drug

Aurobindo gets USFDA nod to market generic Osteoporosis drug

 Aurobindo Pharma today said it has received final approval from USFDA to manufacture and market generic version of Risedronate Sodium tablets, used in the treatment of Osteoporosis, in the American market.

Jubilant Life zooms 10% as firm gets USFDA nod for drug

Jubilant Life zooms 10% as firm gets USFDA nod for drug

Jubilant Life Sciences shares soared almost 10 per cent, to touch its 52-week high level today, as the company received final approval from the US health regulator for its generic version of anti-depressant Paxil tablets.

USFDA gives Dr Reddy's addl time to respond to warning letter

Dr Reddy's Laboratories Ltd (DRL) Thursday said the USFDA has extended the time-frame for replying to the warning letter issued to the company by about two weeks to December 7.

Dr Reddy's shares slump 8.5%; m-cap dips Rs 4,746 crore

Dr Reddy's shares slump 8.5%; m-cap dips Rs 4,746 crore

The stock fell on reports that the US Food and Drug Administration (USFDA) might withhold approval of the company's fresh drugs and stop import after it found several violations at three of its plants.

US FDA warns of DRL drug import ban if flaws are not fixed

The US Food and Drug Administration (US FDA), which had issued a warning letter to Dr Reddy's Laboratories over quality issues, has said it might withhold approval of the company's fresh drugs and stop import if no corrective action is taken.

US court asks Dr Reddy's Laboratories to halt generic sale of esomeprazole

US court asks Dr Reddy's Laboratories to halt generic sale of esomeprazole

A US court has directed Dr Reddy's Laboratories to temporarily stop selling its generic version of esomeprazole in the US market.