The Rs 550-crore Ahmedabad-based Cadila Pharmaceuticals Ltd (CPL) has got its beta lactam (penicillin and cephalosporin dosage forms) formulations plant approved by Therapeutic Goods Administration (TGA), Australia.
This is the second approval to CPL from TGA in less than six months. In February 2001, it had got approval for its non-beta lactam facility, which includes non-sterile and sterile dosage forms.
CPL chairman I A Modi said this approval will pave company's entry into Australia, New Zealand and most of the Pharmaceutical Inspection Cooperation Scheme (PICS) countries such as Germany, Italy, UK, Sweden, Norway, Denmark, France, the Netherlands, Canada, Spain and Singapore.
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Claiming that this TGA approval puts his company in a select league of pharma companies around the world having approval for both beta lactam and non-beta lactam facilities, he stressed that the CPL facility has been approved without any non-conformities.
The manufacturing capacities at non-beta lactam and beta lactam blocks of CPL are one of the largest in the country. Running in two shifts, the non-beta lactam block can produce 3.9 billion tablets, 150 million capsules, 6,000 kilo litre of liquids, 84 million sterile vials and 15.6 tonne of granules per annum.
Similarly the beta lactam facility can annually produce 48 million dry sterile vials, 27 million dry syrup bottles, 630 million capsules and 510 million tablets. The plant also conforms to the Japanese cGMP norms and was approved by Medicine Control Council of South Africa earlier this year.
Emphasising that this approval is the outcome of CPL's consistent thrust and focus on the developed markets, senior vice-president Mukund Modi said that his company was confident of getting 14 products registered in Australia and New Zealand within the next 18 months.
"Our company expects a sale base of $8 million from these two countries by 2004," he added.