Tagged with India

Legal Handbook Preclinical and clinical trial requirements in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition…

Pharma Legal Handbook All about regulation, pricing and reimbursement in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over…

UK Thomas Broeer, managing director UK and Ireland for Aurobindo, has been at the helm of Aurobindo’s UK subsidiary, Milpharm Limited for almost two years and here discusses the UK market’s strengths, the potential impact of Brexit on the pharmaceutical industry and the pricing structures in place in the UK.  …

India Although most industry observers expect that Indian pharma exports to the US will pick up again in the coming years, Indian companies have – in the meantime – been rapidly increasing their efforts to develop stronger footprints in strategic emerging market such as Brazil, Russia and some Asian and African…

India In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance has clearly become strategically important across all layers of Indian organizations, including formulation and API companies as well as both B2B and B2C players.   My approach is extremely simple: quality…

India One issue grinding the gears of the Indian pharmaceutical industry over recent years has been quality compliance. With a number of pharma manufacturers the recipients of warning letters from the US FDA, increased regulatory scrutiny has caused some consternation, but also progress in quality standards across the board. “I see…

India Bhupendra Sangani, founder and managing director of Galentic, one of India’s expert manufacturers of sterile and non-sterile semi-solid products in the dermatology and ophthalmology arenas, provides insights into the international development of his ambitious company in 40+ export markets. In line with the recent set up of Galentic’s new manufacturing…

India Dr. Satyanarayana Chava, founder and CEO of Laurus Labs, provides insights into the distinctive model that has allowed Laurus to become one of the world’s leading API companies as well as the partner of choice of the most prominent MNCs globally – after only 13 years of existence. He also…

India Luca Visini, the recently appointed managing director of Eli Lilly & Company for India, shares with us his first perspective of the Indian ecosystem He also provides insights into some of his key objectives in India, which include consolidating the reputation of Eli Lilly as a key stakeholder in the…

India Dr. Letitia Robinson, Director of the US FDA India Office, provides insights into the main goals and responsibilities of the FDA in India and documents the US FDA’s collaboration efforts with its Indian regulatory counterparts. Could you introduce to our international readers the US FDA’s Office of International Programs and…

India Dr. Deepak Birewar, founder and chairman of the dynamically growing CDMO Inventys Research, highlights the crucial importance of innovation in the company’s strategy to outperform its competition and strengthen its relationships with leading customers globally. Whether it relates to custom manufacturing or the company’s own product portfolio, Dr. Birewar moreover…

India VS Reddy, fondly known as ‘The Protein Man of India’ and founder and managing director of British Biologicals, India’s leading nutraceutical company, provides insights into the pioneering role played by British Biologicals in raising awareness about and fostering the use of nutraceuticals in India, while he documents his plans to…