Cipla Ltd, the Mumbai-based drug company, is planning an investment of $15 million, over a three year period, for setting up formulations units for four products with a view to cater to the US market.

The new units will come up at the company's existing manufacturing location at Kurkhumb in Maharashtra and will be dedicated solely for manufacture of generic variant of drugs whose international patents are scheduled to expire between the year 2003 and 2006. These include drugs for asthma, cardiac ailments and infection. An initial investment of Rs 5 crore will be made in the current financial year.

Cipla is in the process of filing eight abbreviated new drug applications, or ANDAs, in the US. ANDAs are pre-requisites for securing marketing approvals of generic drugs following the expiry of a product patent. The anti-infective molecule, which is among the eight ANDAs prepared by the company, goes off patent in 2003, while the others become generic in the years leading to 2006.

Another area where the company is making similar investments is manufacturing of novel dosage forms or drug delivery systems (NDDS). The company is working on four to five novel drug delivery systems for which it plans to set up exclusive manufacturing plants in Patalganga in Maharashtra and Bangalore. An investment of Rs 10 crore is planned towards this, of which Rs 5 crore will be spent in the current financial year.

Amar Lulla, director, Cipla says the first such novel drug delivery system would hit the Indian markets by the year-end. Significantly, the company is reported to be in talks with an international generics company for supplying the latter an NDDS for the anti-ulcerant omeprazole.

Cashing on its strong thrust on chiral chemistry, Cipla has been successful in developing a resolved and more active form salbutamol - R Salbutamol - by separating the inactive component form of the product.

Company officials claim the resolved product to be more potent and can be used in one-fourth the dosage that Salbutamol is currently given to patients. The new variant, which is in a nebulised form, will be priced at a level comparable to Asthalin - Cipla's existing salbutamol product. 

Cepracor, an US based firm, is the first company to market a product based on R salbutamol, which is not known to cause associated side-effects like tremors as in case of unresolved salbutamol. In June 1999, Cipla announced that it has come out with a non-chlorofluorocabon-based inhaler for the first time in the country.