Page 33 - Usfda

Regulatory worries, price erosion may pull down Dr Reddy's US revenues

Repeat observations for an approved facility are an indication of consistent regulatory challenges for the company, says an analyst with a foreign brokerage

Unichem Laboratories gets USFDA nod to market pain management drug

Unichem said the product will be commercialised from its Ghaziabad, Uttar Pradesh, plant

Alembic Pharma gets US health regulator nod for ophthalmic solution

The company said it now has a total of 86 ANDA approvals from the USFDA

Unichem gets USFDA approval for high blood pressure drug Chlorthalidone

Unichem said the product will be commercialised from its Ghaziabad plant

Natco Pharma's API facility near Hyderabad gets 6 USFDA observations

The company said that key points of the observations in Form 483 are the supplier and service provider agreements to be made more robust

Fund managers bet on pharma sector as pricing pressure in US is stabilising

The Indian pharma sector has many attractive opportunities before it, such as the growing adoption of generic drugs in developed markets

Lupin gets Establishment Inspection Report from FDA for Aurangabad facility

The facility was inspected by the US Food and Drug Administration

Active pharmaceutical ingredients focus helps drug firms offset slowdown

Besides captive consumption, the company also supplies APIs to external customers across international markets

Alembic Pharma gets USFDA nod for neuropathic pain management drug

The approved product is therapeutically equivalent to the reference listed drug Lyrica Capsules

InvaGen Pharma gets USFDA approval for neuropathic pain management drug

Cipla said the approved product is a generic therapeutic equivalent version of Pfizer's Lyrica

Strides Bengaluru unit gets 'Voluntary Indicated Action' status from USFDA

The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage products across multiple formats

Zydus Pharma gets USFDA nod to market attention-deficit hyperactivity drug

The final approval from the United States food and drug administration (USFDA) is to market Dextroamphetamine Saccharate

Dr Reddy's Laboratories unveils generic version of Allegra-D in US

Allegra-D 12 HR is a trademark of Aventisub II Inc

Caplin Labs gets USFDA nod for injection to prevent excessive blood loss

Caplin Steriles said it has developed and filed 11 ANDAs on its own and with partners, with 5 approvals so far

USFDA completes Chennai facility audit with zero observations: Natco Pharma

Shares of Natco Pharma were trading 0.35 per cent higher at Rs 529.95 apiece on BSE

Bird faeces on packages in United Breweries warehouse, says USFDA

None of the pest control records addressed the issue of birds

Glenmark receives final nod from USFDA for drug to treat chronic angina

Glenmark Pharmaceuticals Tuesday said it has received final nod from the US health regulator for its Ranolazine extended-release tablets used for treatment of chronic angina. Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for Ranolazine extended-release tablets in the strengths of 500 mg and 1,000 mg, the company said in a statement. The product is a generic version of Gilead Sciences Inc's Ranexa extended-release tablets in the same strengths, it added. According to IQVIA sales data for the 12-month period ended May 2019, Ranexa extended-release tablets, 500 mg and 1,000 mg market (which includes brand and all available therapeutic equivalents) achieved annual sales of around USD 929 million, Glenmark said. The company's current portfolio consists of 158 products authorised for distribution in the US marketplace and 57 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it ...

USFDA issues 12 observations for three units of Biocon in Malaysia

The company, however, did not provide any details about the observations made by the US regulator

Strides Pharma Puducherry unit receives warning letter from USFDA

The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator.

Dr Reddy's Laboratories, Cipla arm recall drugs from American market

The USFDA has classified both the recalls as a Class-II recall