Our journey to make a difference through improved healthcare began with the incorporation of Claris Lifesciences in 1999.
Guided by the philosophy of 'Emotional Pharmacopoeia', which means that a drug is considered suitable for sale only if we are comfortable administering it to our loved ones, our commitment to quality and excellence helped us achieve our motto of saving Earth's most precious resource: human lives.
In 2002, with the aim of targeting international markets through niche and difficult-to-manufacture drugs, Claris entered the Injectables business.
Injectable drugs are administered directly into the bloodstream, bypassing the immune defences associated with the gastrointestinal system. The increasing preference for injectables is directly related to their ability to address challenging medical conditions with an accurate degree of selectivity.
What began as an earnest mission to deliver products that healed better, grew into one of the largest Indian sterile pure play injectables pharmaceutical companies with a presence in 100+ countries worldwide. Our products offering comprised of about 130 products across multiple markets and therapeutic areas. All the products were off-patent products, a significant majority of which were capable of being directly injected into the body and predominantly used in the treatment of critical illnesses.
Claris' state-of-the-art manufacturing campus, spread over 80 acres, hosted our injectables, infusions and API plants, serving patient needs in the areas of Anaesthesia & Analgesia, Clinical Nutrition, Blood Products, Anti-infectives & Anti-fungals, Antibiotics, Renal Care and Oncology.
Our expertise in process technologies such as emulsion and aqueous reflected in our manufacturing range of delivery systems, including glass bottles, vials, ampoules, and non-PVC and PVC bags. The versatility of Claris products and processes, catering to specific geographic requirements, augmented the care provided by government and private hospitals, aid agencies and nursing homes.
Apart from being one of the few emerging market suppliers of injectable products, Claris' expertise in lipid-based technology also made it one of the handful of companies in the world to manufacture Propofol, a front-runner in anaesthesia, and a technically complex product to manufacture.
Propofol is an injectable anaesthetic drug that allows targeted use with extremely quick recovery time, i.e., up to ten minutes, and helps in inducing and regulating anaesthesia levels, especially in major surgeries, without the side effects, such as nausea and vomiting, which are commonly associated with other drugs used for anaesthesia. Our flagship product, Profol/Provive eventually became the top propofol brand in India, with a 55% market share. We also developed a value-added variant, the Propofol MCT-LCT for the European market.
For the Critical Care segment, our product range included TetraHES (tetrastarch) and Hestar (pentastarch), for which we were granted patents in India. Products in this segment are used during or after the surgical conditions or trauma conditions for the treatment or recovery. These plasma volume expanders (PVEs) and blood products are used when the human body loses blood in large quantities. PVEs hold the blood pressure of the body and stabilise the body by restoring the blood volume, water and crucial salts.
We were also one of the few companies in the world to develop Activated Pharmaceutical Ingredients (APIs) such as Hydroxyethyl Starch and Iron Sucrose, a pivotal drug for treatment in renal therapy. In the oncology care segment, we achieved a process first with the manufacturing of products using innovative pegylated liposomal technology. Lipeg, our product which we manufactured using this technology allowed for a targeted delivery of the basic molecule (e.g. doxorubicin) that is cytotoxic or destructive in nature, confining it to the effected cancerous area, thus benefiting the patient through reduced side effects.
Yet another first was the manufacturing of UniKit - a unique and significant delivery system for dry-wet injectable combinations.
Buoyed by the reception of our products, in 2006 the Carlyle Group, one of the world's largest private equity firms, invested $20m in Claris Lifesciences for an 11% stake in the business. In 2009, we entered into a business arrangement with Pfizer Asia Contract Operations Pvt. Ltd. for marketing and supply of 15 Claris-manufactured sterile injectables in the highly regulated USA, Canada, Europe, Australia and New Zealand markets.
By 2014, our market reach spanned over a 100 countries, including the USA, Europe, Canada, Australia, New Zealand and South Africa.
The first-mover advantage was a critical propellant in the Claris growth story. Our expertise in Novel Drug Delivery Systems (NDDS) provided us with a competitive advantage, which was anchored by a strong Quality by Design approach. Our R&D facility was approved by the Department of Science and Technology, Government of India, while our manufacturing facilities featured the best of international suppliers, such as the double pass reverse osmosis system from Christ (Switzerland); distillation columns from Stillmas (Italy); manufacturing vessels from Diesel (Germany); SVP manufacturing
lines from Robert Bosch (Germany); sterilisers from SBM (Austria); leak testing machines from Breviti (Italy); and cleanrooms from Clestra (France).
As one of the few Indian companies with regulated market capabilities across complex delivery systems and technologies, Claris' manufacturing and quality systems were awarded the toughest of regulatory approvals, including the US FDA, the MHRA (United Kingdom), TGA (Australia), ANVISA (Brasil), ANVIMA (Colombia) and GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates). They were also ISO 9001-2000 and WHO GMP certified.
The USA FDA approval of our injectables manufacturing plant in 2007 made it one of the few-of-its-kind integrated facilities globally, to receive acceptance from the most stringent of regulatory authorities.
We continued to add new products, new geographies and new technologies, with innovative generics remaining the primary focus. Our integrated business model, which was backed by a trained workforce across business divisions, such
as regulatory affairs for obtaining product registrations, manufacturing, supply chain management, and sales and marketing, and their deep understanding of the injectables business, allowed us to better control variables in our business processes.
Propelled by an entrepreneurial culture, highly efficient processes and an ambitious team of over 4,000 staffers and workers, the outstanding growth story of Claris Injectables business earned plaudits in India and abroad. Throughout our journey, Claris won numerous awards, the highlight being the India Manufacturing Excellence Award (IMEA), instituted by Frost & Sullivan, for three years in a row; the Indian Drug Manufacturers' Association Quality Excellence Award (IDMA), four
times; and the Greentech Safety Award, twice.
At a time when the Indian pharma industry was setting a growth forecast of 15% Claris experienced a consistent four years of year-on-year growth of 48% from 2013 to 2017. In 2017, the global generic Injectables business was sold to Baxter International Inc., USA, (a Fortune 500 American Healthcare company), for $625m (Rs4,237cr).
Claris' rapid success and global legacy was a direct result of our persistent drive for excellence. We began as a small dream, with limited capital and resources. We persevered through some of the worst times of the industry and had the gumption to grow, eventually ranking among world leaders. Our differentiated business model among Indian pharmaceutical companies was due to our focus on a range of complex products that require sophisticated technical processes and quality assurance methods. Our expertise in launching hero products, backed by cutting-edge technology, received an overwhelming response from all the markets we built our presence in, domestic as well as international.
At Claris, our passion for success, is unmistakable.