Aurobindo, Unichem recall products in US market
The affected lot contains 6.25 mg Carvedilol tablets, which have been produced in India and distributed in the US by Princeton-based Aurobindo Pharma USA Inc.
The affected lot contains 6.25 mg Carvedilol tablets, which have been produced in India and distributed in the US by Princeton-based Aurobindo Pharma USA Inc.
In an interview to ET, Pranav Amin, Managing Director of Alembic Pharmaceuticals said the management still remains bullish on the US market, to beat pricing erosion - the company is planning to launch at least 15 products and also working on cost optimisation.
The acquisition is expected to significantly boost the New York Stock Exchange (NYSE) listed Amneal’s injectables manufacturing infrastructure, capabilities, and capacity to support the US and international markets.
The company is recalling 28,658 cartons of Fulvestrant injection (250 mg/5 ml), a medicine used to treat breast cancer, due to "lack of assurance of sterility", the US health regulator noted in the report.
The company has launched Chlordiazepoxide Hydrochloride and Clidinium Bromide capsules USP, 5 mg/2.5 mg in the US market, Dr Reddy's Laboratories said in a regulatory filing.
Nitazoxanide tablets, 500 mg, are indicated in the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 years of age and older.
The Mumbai-based drug firm's product is the generic equivalent of Mylan Specialty's Depen tablets, which are indicated for the treatment of Wilson's disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.
The company has launched the product, which is a generic version of Teijin Ltd's Uloric tablets, after getting approval from the US Food and Drug Administration (USFDA), the company said in a regulatory filing.
While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid.
Sharing information with shareholders, Sun Pharmaceutical Industries Managing Director Dilip Shanghvi said the company's strategy of developing the specialty business as an additional growth engine has started delivering results, with a gradual ramp up in specialty revenues.
Dr Reddy's said Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2 per cent and 0.1 per cent, are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.