Lake Chemicals Pvt Ltd, the bulk drug subsidiary of Bal Pharma has received a DMI from Canada for the manufacture of three bulk drugs namely Alprazohan, Clonazepan and Nitrezapam.

The company has commercialised six products and research is going on for the production of Lopamermide, Olanzapine, Midazolam and Ritodrine. Another five to six niche productions are under development, according to Shailesh Siroya, managing director Bal Pharma and who heads Lake Chemicals. The products under development are Venlafacine (anti depressant), Clobazam (anticonvulsant /anxiolytic) and Ritrodine (anti diabetic). The exports of the unit account for 40 percent of the production.

"Our focus is to concentrate on niche products and we are right now targeting our strategies to the US FDA approved markets," Siroya informed. Right now the company caters to the Latin American, Europe, Far East and Argentina.

It has also received the certificate of suitability for Gliclazide which allows the company to enter the European markets and is now geared up for increased production schedules. The total consumption of Gliclazide is around 3 to 4 tonnes a month and the market size is 1500 kg which is twice that of insulin products.

The company has also set apart Rs. 2 crore for upgradation of the plant. It has also scaled up its operations to manufacture Ebastine (anti histamine) and has applied for European registration for exports to Europe, Pakistan, Bangladesh and Latin America. The bulk drugs market in India is around Rs. 15,000 crore.

The main bulk drug players in the State are Biocon India Group, Strides Arcolabs, Resonance, RL Fine Chemicals, Lake Chemicals located in Bangalore, Max India in Mysore and Shilpa Antibiotics in Raichur.

According to Siroya, the scene will be encouraging for bulk drug manufacturers if companies produce niche products. There are only a few players worldwide who manufacture the complete range of bulk drugs. Many companies have run into serious issue of excise notifications, hassles from the National Pharmaceutical Pricing Authority and drugs controller approvals.

Bal Pharma, with a turnover of Rs. 45 crore is going aggressive on its range of drugs in diabetology and cardiology. It has already launched Simvastatin and is in the process of introducing Atrovastatin and Pyoglitizone this month. The company is also in the process of starting 'Bal Vaidya' its Ayurveda formulation division where six products are underway in the areas of cholesterol, general health booster, appetiser and for diabetes.

Lake Chemicals, started in 1992 to manufacture a class of compounds known as Benzodiazapin, an intermediate of Alprazolam which is used in the production of drugs related psychiatry, anxiolytic, epileptic and insomnia conditions. Lake Chemicals started off with an investment of Rs. 5 crore and is now on to identify strategic partners to enter the US market.

The current product profile of the company includes Alprazolam (anxiolytic), Buproplon (antidepressant), clonazepam (anti convulsant), Haloperidol (antipsychotic), Lorazepam (tranquilliser), Mesterlone (androgen), Nitrazepam (anti convulsant), Olanzapine (anti psychotic), Terbutaline sulphate (bronchodialator) and Terfandine (antihistamine).