- Sanofi's vaccines unit, Sanofi Pasteur, has started commercial vaccine production at its new facility in Hyderabad, India, the company said Tuesday.
- While the facility will eventually produce vaccines against a number of diseases, Sanofi Pasteur will at first only produce its pediatric pentavalent vaccine Shan5 there.
- Sanofi subsidiary Shantha Biotechnics operates the Hyderabad facility, which is located in the Special Economic Zone Muppireddipalli.
Sanofi Pasteur acquired Shantha in 2009 and started construction on the roughly 200,000 square foot manufacturing facility in 2010.
The World Health Organization prequalifed the Shan5 vaccine in April 2014, after reviewing the production process and inspecting the manufacturing site. Shan5, a pentavalent vaccine, protects against diphtheria, tetanus, pertussis, Hib, and hepatitis B. It is intended for use in children between the ages of six months and five years.
Since Shan5 as launched in March 2014, over 30 million vaccinations have been administered, mainly to children in GAVI-supported countries, Sanofi Pasteur said.
Sales of Sanofi Pasteur vaccines were up 8.2% in the first three months of 2016, compared to a year prior. Sanofi's dengue vaccine registered its first sales, as the Philippines began a public immunization drive.
But, the vaccine may have hit a setback in India after a top committee at the Indian Health Ministry rejected Sanofi's request to waive further late-stage trials. Sanofi has conducted phase 3 trials in other countries and is seeking to have India's requirement for locally-conducted trials waived.