Indian FDA approves Innovus Pharma's Zestra, Zestra Glide, EjectDelay and Sensum+
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Products now approved in seven countries.
Innovus Pharmaceuticals has announced that its partner Khandelwal Laboratories has received the approval of the product licenses for Zestra, Zestra Glide, EjectDelay and Sensum+ from the Indian FDA, The Drugs Controller General (India), and the Directorate General of Health Services to commercialize the products in India.
"We are thrilled to have received the approval to commercialize our products from the Indian FDA in a very short time due to the strength of the dossier and the clinical trials. India is our seventh country where we have our products approved and we look forward to start the commercial launch by our partner Khandelwal Labs in the very near future," said Dr Bassam Damaj, President and CEO of Innovus Pharmaceuticals, Inc.
On 10 September 2015, Innovus Pharma entered into an exclusive marketing and distribution agreement with Khandelwal Laboratories based in India (KLab) under which Innovus Pharma has granted to KLab an exclusive 10-year license and distribution rights to market and sell Innovus Pharma's products. These products include Zestra to increase Female Sexual Arousal and Desire and Satisfaction, EjectDelay for treating premature ejaculation, Sensum+ to increase penile sensitivity and Zestra Glide, the high-viscosity water-based lubricant. If KLabs exceeds its minimum yearly orders, the agreement has two 5-year term extensions. Under the agreement, the minimum orders for the first term of the agreement are over two million and six hundred thousand ($2.6 million) US dollars annually.
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