One of India largest sterile Injectables company, Claris Lifesciences Limited (Claris/Company), announced today that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA has concluded that the inspection stands closed and the facility was found to be acceptable.
The US FDA had conducted audit at Claris; manufacturing facility in May, 2015, the Company had taken appropriate steps to address the observations it had received from these audits.
Having received the EIR from the US FDA potentially clears the path for the Company to receive product approvals (ANDA) for the USA. The Company presently has 13 ANDAs approved in the USA which account for about US$ 200 million of market size and it has an additional 26 ANDAs, with an addressable market size of around US$ 1.5 billion, under approval. The Company expects 5-7 ANDA approvals in the near future, these ANDAs approvals could increase the addressable market size of the Company products in the USA by around US$ 240 million.
About Claris Lifesciences Limited (CLL)
CLL is a multi-business enterprise and the Holding Company of Claris Injectables Limited, a wholly-owned subsidiary dealing in Specialty Injectables business and Claris Otsuka Private Limited, a Joint Venture with Japanese Otsuka Pharmaceutical Factory, Inc. Mitsui Co. Ltd. for Infusion business in India Emerging Markets.
About Claris Injectables Limited (CIL)
CIL manufactures and/or markets products across multiple delivery systems, markets, and therapeutic segments including anaesthesia, blood products, anti-infectives, and plasma volume expanders. A significant majority of these products are generic drugs, capable of being directly injected into the human body, predominantly used in the treatment of critical illnesses.
The customer base primarily includes government private hospitals, aid agencies, and nursing homes. With emphasis on quality, technology, and innovation, we offer a range of niche technology-driven injectable products across delivery systems such as glass bottles, vials ampoules, and non-PVC/PVC bags.
About Claris Otsuka Private Limited (COPL)
Claris Otsuka, a leader in intravenous nutrition products, is committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition.
The product range stretches across various therapeutic segments, including infusion therapy, parenteral nutrition, anti-infectives, and plasma volume expanders. The products are offered through various delivery systems, such as glass and plastic bottles (EURO Head Nipple Head), ampoules, and non-PVC/PVC bags. The customer base primarily includes government private hospitals, aid agencies, and nursing homes.
For more information about the Company, log on to:www.clarislifesciences.com
This press release may include forward-looking statements; including but not limited to budget forecasts and projections; which involve a number of risks, uncertainties and other factors that may cause the actual results to differ materially. Such factors include; but are not limited to; change in local and global economic conditions our ability to successfully implement our strategy, the market acceptance of and demand of our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from the actual returns, in future. Claris Lifesciences Limited does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date thereof. Market information mentioned in the press release is based on IMS Data and/or internal estimates of the Company.