Established in Hyderabad, India in 1978, Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets. We operate primarily under a business to business (B2B) model and have an excellent track record in the development, manufacturing and marketing of complex injectables. This presence across the value chain has helped us witness exponential growth. We are promoted by Shanghai Fosun Pharma, a global pharmaceutical major.
With our proven performance in complex injectables across development, manufacturing and marketing, we are sufficiently enabled to meet diverse injectable needs across a vast range of specific requirements. Our 22 production lines for finished formulations across four facilities are complimented by three facilities for Active Pharmaceutical Ingredients (API). Plans are underway to augment the present manufacturing capacity of approximately 750 million units in the medium term to support future growth.
The ability to provide therapeutic medicines on the best quality parameters and at the right price, is the overriding objective for us at Gland Pharma. All other factors remaining equal, backward integration and economies of scale play a significant role in providing quality medications at the right price. Over the years, we have been able to move ahead on both those counts, to establish a presence across the entire value chain in Injectables.
A manufacturing base with installed capacity of 750 million units per annum spread over seven facilities; proven Research and Development wing; pan-India and global distribution and sales network; affiliation with national and state level healthcare institutions; compliance with all necessary regulatory boards; and a high level of approvals and pending filings in our area of operations, all contribute to our standing in the pharma domain.
Our family of investors and other stakeholders are the driving force that gives us a sharp focus on good governance in all our areas of operations and services. And by doing so, we are reiterating our firm resolve to deliver value and satisfaction.
Our four best-in-class, cGMP-compliant formulation manufacturing facilities manufacture a wide range of injectables using aseptic filling or terminal sterilization, as applicable. The facilities are equipped for production flexibility and can switch product lines seamlessly, eliminating need to install additional production lines to meet altered product specifications and market mechanics of demand and supply.
Our facilities have received accreditations from the following regulatory bodies:
Our 600,000 sq. ft. flagship sterile injectable facility in Dundigal, Hyderabad - USFDA approved since 2003 - possesses capabilities across various delivery formats.
The sterile injectable facility in Pashamylaram, Hyderabad, after selling in the domestic since July, 2015; obtained USFDA approval in April 2016 and entered the USA market in September 2016. Output at this facility has nearly doubled our manufacturing capacity.
A dedicated Penems facility, after filing its first ANDA in September 2013, obtained USFDA approval in April 2016.
Our oncology facility after receiving USFDA and GMP (EU) approval in 2014, began sales in Europe in 2015 and in the United States in 2016.