Pharmaceutical Laboratories, the US subsidiary of Sun
Pharmaceutical, has started the manufacturing and marketing of two
recently approved drugs in the US, Caraco Pharma CEO Narendra N
two drugs are Clonazepam and Carbamazepine (chewable form).
Clonazepam is a neuropsychiatric drug used for seizure
disorders and panic disorders. It is a bioequivalent of
Roches Klonopin, with an estimated total US drug market
of $140 million.
Though, Sun Pharma
acquired Caraco around three years back, due to different USFDA
procedural delays the promoters could not start the drug
production till May this 2001.
bioequivalent of Novartis''s Tegretol, is used for the treatment of
epilepsy. The total US drug market for the chewable form is
estimated at $20 million.
Borkar said the company
is preparing for the manufacture and marketing of a third
FDA-approved drug, Flurbipofen, a bioequivalent of Pharmacias
Ansaid, which is a nonsteroid anti-inflammatory used for pain
management and the treatment of rheumatological diseases such as
Borkars company has
submitted one more abbreviated new drug application for FDA
approval during the third quarter of 2001. Seven drugs are now
pending FDA approval, with approvals for some of these expected by
end of this year.
Caraco has an extensive
R&D centre at its Detroit headquarters complex and receives
R&D support from Sun Pharmaceutical. Sun is a Caraco
stockholder, and has agreed to supply Caraco with technology for
25 generic drugs. To date, Caraco has received technology for 11
The Detroit-based Caraco
Pharma develops, manufactures and distributes generic and
private-label prescription drugs to the nations largest
distributors, drug-store chains and healthcare systems.