Granules India Limited

History

Granules India was formed in 1984 as Triton Laboratories. Triton produced Paracetamol API at its Bonthapally factory on the outskirts of Hyderabad. Triton scientists found a more efficient way to produce the Paracetamol API, which led to lower capital and raw material requirements. In 1987, Triton became the only Indian company aside from Dr. Reddy’s Laboratories to export pharmaceutical products to the U.S.

Though Triton was growing as an API manufacturer, management decided it could create a value added version of its product. In order to distinguish itself from competitors, Triton management pioneered the concept of manufacturing and selling in bulk granulated Paracetamol, also known as direct compressible grade material (DC), or "PFI". In 1990, it opened its second manufacturing facility at Jeedimetla to produce multiple APIs.

In 1991, management set up a new entity, which was incorporated as Granules India Limited. Soon after Granules applied the PFI concept to other APIs, set up a PFI facility at Jeedimetla and began exporting the material to various markets including the U.S., Germany and Australia.

In 1995, Granules became a public company, after having initial public offerings on the Bombay and Hyderabad Stock Exchanges.

In 2001, the API and PFI blocks at Jeedimetla facility received approval from the U.S. FDA.

In 2002, Granules started building a new PFI plant in Gagillapur. The facility opened in August 2003. The facility is one of the largest of its kind in the world. In order to secure API for its Ibuprofen PFI, Granules formed a joint-venture with Hubei Biocause Heilen Pharmaceutical to create Granules Biocause in Wuhan, China. The jointly owned Ibuprofen plant is among the biggest plants of its kind in the world.

In 2004, Granules obtained approval from U.S. FDA, Australian TGA and German Health Authority for the Gagillapur facility. In 2007, the Bonthapally new API facility was audited and approved by the FDA.

In 2008, the Gagillapur plant started production of tablets. In 2010, Granules received U.S. FDA approval for its first Abbreviated New Drug Application (ANDA).

In 2011, Granules established Granules-OmniChem, a joint venture with Ajinomoto OmniChem to venture into Contract Research And Manufacturing Services(CRAMS) business with a manufacturing facility at Vizag SEZ.

In 2013, Granules opened a 10,000 sq. foot R&D facility at Pragathi Nagar in Hyderabad. In the same year the company signed an agreement to acquire Auctus Pharma, which includes twelve APIs in its product portfolio as well as key intermediates of those APIs. It has two manufacturing facilities, an API facility in Vizag and an Intermediate facility in Hyderabad.

Infrastructure

Granules has seven manufacturing facilities; six are in India while the seventh is through a joint-venture with Hubei Biocase in Wuhan, China. The company also has two research centres, at Hyderabad and Pune.

The Gagillapur facility is located near Hyderabad and has a Finished Dosage block, a PFI block and a research & development facility.

Granules commissioned the world’s single largest PFI plant in Gagillapur in August 2003 with a batch size of 6 MT and an annual capacity of 7,200 MT per annum. The plant received its US FDA approval within six months of commissioning.

People

Granules India's Board of Directors include: