USFDA

Dr Reddy's shares jump 7.5%; mcap rises by Rs 2,864 crore

Dr Reddy's shares jump 7.5%; mcap rises by Rs 2,864 crore

The company's market valuation went up by Rs 2,864.35 crore to Rs 41,223.35 crore.

Sep 21, 2017, 17:07 PM IST
Sun Pharma sees single-digit decline in revenues for FY18

Sun Pharma sees single-digit decline in revenues for FY18

On US FDA inspection, Shanghvi said on completion of re- inspection, the USFDA issued nine observations for the Halol facility and the company is currently in the process of implementing the requisite remediation steps.

Sep 03, 2017, 14:00 PM IST
Sindoor may carry religious significance, but it is unsafe too! - Read

Sindoor may carry religious significance, but it is unsafe too! - Read

The FDA’s limit for lead in cosmetics is 20 micrograms per gram. Nineteen percent of the US samples and 43 percent of the India samples exceeded that limit. 

Aug 29, 2017, 13:29 PM IST
Class action lawsuit filed against Dr Reddy's in US

Class action lawsuit filed against Dr Reddy's in US

Drug firm Dr Reddy's Laboratories on Monday said a class action lawsuit has been filed against it in the US by an investor alleging misleading statements in violation of the US federal securities laws.

Aug 28, 2017, 15:28 PM IST
Cadila Healthcare soars 7% on USFDA nod for hypertension drug

Cadila Healthcare soars 7% on USFDA nod for hypertension drug

The scrip settled 7.02 per cent higher at Rs 494.95 on the BSE. In the intra-day trade, the stock climbed 8.95 per cent to the day's high of Rs 503.90 on the BSE.

Aug 24, 2017, 17:14 PM IST

Lupin extends losses, loses m-cap by Rs 3,315 crore in 2 days

Registering losses for the second day, Lupin on Wednesday fell by 3 percent on US health regulator's observations for its Goa plant.

May 03, 2017, 17:10 PM IST
USFDA issues 11 observations for Sun Pharma's Dadra facility

USFDA issues 11 observations for Sun Pharma's Dadra facility

Drug major Sun Pharmaceutical Industries has received 11 observations from the US health regulator after inspection of its Dadra facility.

Apr 22, 2017, 18:54 PM IST
Cipla gets USFDA nod for generic HIV drug

Cipla gets USFDA nod for generic HIV drug

Cipla has received approval from the US health regulator for its generic Abacavir and Lamivudine tablets used for treatment of HIV infection.

Apr 04, 2017, 15:14 PM IST
Pharma major Lupin gets USFDA nod to market colonoscopy drugs, pain relief

Pharma major Lupin gets USFDA nod to market colonoscopy drugs, pain relief

The approved product is indicated for relief of moderate to moderately severe pain. Percocet tablets had US sales of USD 838.7 million.

Feb 28, 2017, 13:44 PM IST
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.

Jul 07, 2016, 17:08 PM IST

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.

May 25, 2016, 16:19 PM IST

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.

Apr 25, 2016, 20:05 PM IST

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.

Apr 11, 2016, 08:23 AM IST

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.

Apr 08, 2016, 15:52 PM IST
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.

Apr 06, 2016, 20:03 PM IST
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

Mar 31, 2016, 16:18 PM IST
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.

Mar 29, 2016, 14:22 PM IST

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.

Mar 21, 2016, 10:33 AM IST
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

Mar 19, 2016, 15:22 PM IST

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)

Mar 15, 2016, 18:09 PM IST