We are a pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products. We commenced operations in 1999 as a provider of contract formulation development services to pharmaceutical companies. We operationalized our oral solids manufacturing facility at Ambernath, Maharashtra, India in 2011 and expanded our service offering to contract development and manufacturing services for products intended for regulated markets. In 2012, we changed focus from providing contract services to developing, manufacturing, and commercializing our own products in the US market.
We carry out product development activities at two facilities – our principal R&D facility is located in Thane, Maharashtra, India where we develop multiple dosage forms and product categories, and our development center for inhalation and nasal products is located in Ontario, Canada. Our two US FDA-inspected pharmaceutical manufacturing facilities, both located in Maharashtra, India, are together capable of producing oral solid dose products, oral liquid products, as well as unit-dose, bi-dose, and multi-dose nasal spray products in an environment of US cGMP. Our facilities are also accredited with other regulators including the MHRA UK, Health Canada and TGA among others.
As of March 31, 2024, we, directly or through our Subsidiaries, collectively have 59 active ANDAs and 10 active NDAs (acquired by Validus) approved by the US FDA. Our products are marketed in the US by our whollyowned subsidiaries, AdvaGen Pharma and Validus, with some products marketed by third-party distributors. Through the acquisition of Validus in February 2024, we market two brands in the CNS therapy area. These do not have substitutable generics approved by the USFDA and have thus strengthened our specialty pharmaceutical business in the US.
We, directly or through third-party distribution partners, have also registered or filed 16 product applications across Australia, United Kingdom, Singapore, Saudi Arabia, and the United Arab Emirates and expect to commence commercial activities upon receipt of approvals. We also provide contract manufacturing services to select customers for India, Australia, and New Zealand markets.
To know more about our infrastructure visit our Operations page.