Unichem gets quality certificate from European Directorate

MUMBAI: Unichem Laboratories has received from European Directorate the Quality of Medicines and Healthcare certificate for its active substances plant at Roha.

The EU GMP approval includes products like Hydrochlorothiazide, Metronidazole, Bendroflumethiazide, Amlodipine besilate, Flutamide.

Recently, the company received final approval from US Food & Drug Administration for Zaleplon Capsules in the strengths of 5 mg and 10 mg.

Zaleplon is indicated for the short-term treatment of insomia. Zaleplon capsules are generic of Kings Pharmaceuticals' Sonata capsules. Unichem received the approval immediately on expiry of the patent on Zaleplon.

The company intends to launch the product in US market shortly.

On Friday, Unichem shares ended up 0.86 per cent at Rs 152.05 on BSE.