DRUG FIRM Indoco Remedies has said that it has received approval from the US health regulator for Olanzapine tablets, used for the treatment of schizophrenia and bipolar disorder.
The approved product is therapeutically equivalent to the reference listed drug 'Zyprexa' of Eli Lilly.
In a BSE filing, Indoco Remedies announced receipt of approval for its abbreviated new drug application (ANDA) for Olanzapine Tablets USP in the strengths of 2.5mg, 5mg, 7.5 mg, 10mg, 15mg and 20 mg.
Quoting IMS data, Indoco Remedies said the US market size of Olanzapine tablets is $65 million.
Indoco Remedies managing director Aditi Kare Panandikar said this approval from the US health regulator will further supplement the solid dosage business for Indoco in the US.
According to the company, the drug may also be used in combination with other medication to treat depression and certain mental conditions.
Indoco Remedies is a fully integrated, research-oriented pharma company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs).
Based in Mumbai, it has seven decades of presence in the Indian Pharma market and a strong foothold in the international market across 55 countries.
The $145 million company employs around 6000 personnel, including over 300 skilled scientists.
Damian Talbot
Nirmala Sitharaman speaks at the India-UK Investor Roundtable in London last Wednesday (9). On the panel were India’s department of economic affairs secretary Ajay Seth and Kotak Mahindra Bank founder Uday Kotak
Sitharaman with Sir Keir Starmer and Rachel Reeves
Sitharaman with Jonathan Reynolds 
Sitharaman with Reynolds, Alastair King, India’s high commissioner Vikram Doraiswami and other delegates