Drug manufacturer Cadila Healthcare has plans to launch 10 vaccines in India next year which are currently under development.
In a post financial result earnings call, Cadila Healthcare Chief Operating Officer Ganesh Nayak told analysts that around 10 vaccines are under development and that the company plans to launch them in India next year.
The company will initially launch the vaccines in the private market and would then try to enter the government tender market, according to Nayak.
"Over the next 3-5 years, we expect a business of Rs 250 crore from this market," he said.
India's total vaccine market is currently estimated at around Rs 3,000 crore, with key players such as Serum Institute of India, Aventis Pharma and GlaxoSmithKline Pharmaceuticals, among others.
The Ahmedabad-based company has also said that it made sizable investments into its transdermals, biosimilars and vaccines portfolio.
On its Moraiya facility, which was issued a Form 483 last year by the US Food and Drug Administration (FDA), the company said it is keeping the US regulator updated and aware of the measures taken to address the issues raised.
Cadila Healthcare's Moraiya facility in Gujarat was issued a Form 483 regarding certain observations and was asked to submit details related to an abbreviated new drug applications (ANDA) filed by the company in the US.
Karvy Stock Broking, a brokerage firm, said in its report, "The company expects resolution of the US FDA Form 483 issue at the Moraiya plant in 2 months time and should get clearance of the plant in the near term. The company's July 2014 issue regarding a product has been resolved while the August 2014 issue regarding the facility is pending. The company is submitting data on a regular basis to the US FDA regarding modifications done at its Moraiya facility. The company is confident of getting 20 products approvals in FY16, which clearly shows the company's confidence in resolution of the Form 483."
The company aims to make 40-plus filings in the US in the current fiscal, which would be a mix of both patent and generic drugs. In generics, it plans to file for more products with less market competition. The company expects more approvals to come now as it now takes less time to get a product acceptance in the US market. It also plans to launch more high value products in the US in the next 12-18 months.
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