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Zydus Cadila obtains FDA OK for 2 generics


Zydus Cadila has obtained the Food and Drug Administration’s nod for two generics.

The first product, Fingolimod capsules, in a dosage strength of 0.5 mg, provides a treatment for patients with relapsing forms of multiple sclerosis.

The product is the generic of Novartis’ Gilenya.

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

Zydus Cadila also has received the FDA’s nod for verapamil hydrochloride injection, in dosage strengths of 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL), in Single-Dose Vials. Verapamil injection is used to rapidly or temporarily restore normal heartbeats in people with certain heart rhythm disorders.

The product is the generic of Isoptin injection. The injections will be manufactured at the company's manufacturing facility at Jarod, near Vadodara (formerly known as Liva Pharmaceuticals).

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