Cipla’s US subsidiary receives final approval for generic Renvela Tablets

India Infoline News Service | Mumbai | October 27, 2017 09:58 IST

Cipla’s US subsidiary, InvaGen Pharmaceuticals Inc. (collectively Cipla), has received final approval for its Abbreviated New Drug Application (ANDA) for Sevelamer Carbonate tablets, 800 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Genzyme’s Renvela tablets.

Cipla
Cipla’s US subsidiary, InvaGen Pharmaceuticals Inc. (collectively Cipla), has received final approval for its Abbreviated New Drug Application (ANDA) for Sevelamer Carbonate tablets, 800 mg, from the USFDA to market a generic version of Genzyme’s Renvela tablets, 800 mg.

Renvela tablets, 800 mg of Genzyme Corporation and are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis.

This approval is positive for the company as this is the niche product which could improve its market share in the US and hence it is expected to improve its US revenues.

Renvela tablets had US sales of ~12,000 cr for the 12-month period ending August 2017, according to IMS Health.

We believe its US business growth is expected to improve from 3QFY18E, driven by the launch of at least one niche product per quarter. Cipla’s focus on cost optimization also continues. This with a gradual recovery in India business should lead to improvement in margins. We have a positive outlook on the stock.

Cipla Ltd is currently trading at Rs 620.45, up by Rs 8.05 or 1.31% from its previous closing of Rs 612.4 on the BSE. The stock is currently trading above its 50 DMA.

BSE 575.85 [14.95] ([2.53]%)

***Note: This is a NSE Chart

 

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