Granules India Limited is a large-scale vertically integrated Company founded in 1991 manufacturing Active Pharmaceutical Ingredient (API), Pharmaceutical Formulation Intermediate (PFI) and Finished Dosage (FD). The Company over the years has created a strong presence in ‘the first line of defence’ products such as Paracetamol, Ibuprofen, Metformin, Methocarbamol, and Guaifenesin.

The company’s product-focused, vertically integrated business model has created a leadership position in several generic drugs. It has a strong presence in ‘first line of defence’ products, including Paracetamol, Ibuprofen, Guaifenesin and Metformin. It exports nearly 60% of its revenue to the US and Europe. Its key customers include some of the leading generic, as well as, branded pharmaceutical companies. Its integrated model for manufacturing APIs, PFIs and Finished Dosages enables it to provide products across the value chain and enhances its competitiveness. It has emerged into a knowledge driven, R&D focused, multi-product organization, with inherent strength in efficient manufacturing of high-volume pharmaceutical products.

Business area of the company

Granules India is one of the vertically integrated, high-growth pharmaceutical manufacturing company in India today. Based out of Hyderabad, India, it is into manufacturing Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediaries (PFIs) and Finished Dosages (FDs).

Products of the company

• Active Pharmaceutical Ingredients
• Pharmaceutical Formulation Intermediates
• Finished Dosages
• Speciality Products

Milestones

• 1991: Trading of APIs
• 1994: Production of various APIs
• 1995: Venture into the manufacture of DC Paracetemol (PFI)
• 1996: Targeting of OTC market in the US for Paracetemol PFI.
• 1998: Expansion of PFI capacity.
• 2000: Obtaining US FDA approval for PFI and other APIs.
• 2001: Development of new PFIs such as Guaifenesin, Metformin and Ibuprofen etc.
• 2002: Filing of new DMFs of the above PFIs and moving up of value chain in OTC products.
• 2003: Setting up of the world's single largest PFI facility with a capacity of 7,200 TPA.
• 2004: The only company in the world to manufacture combination PFIs on a commercial scale using different basic APIs with other excipients.
• 2004: Addition of a Tableting facility with a capacity of one billion pieces per annum
• 2005: Started construction of the Tableting facility with a capacity of 12 billion tablets.
• 2006: Major expansion of Paracetamol facility, from a capacity of 3600 MT to 12000MT per annum
• 2010: Granuels India Receives U.S. FDA Approval for its Metformin ANDA.
• 2011: Granules established Granules-OmniChem, a JV with Ajinomoto OmniChem. The business focuses on the CRAMS space
• 2012: Granules India Awarded India’s Most Admired Company in Exports & India’s Most Admired Company in Bulk Drugs.
• 2012: Granules India Awarded Outstanding Exports - Formulations Award 2011-12 by Pharmexcil.
• 2013: Granules acquired Auctus Pharma.
• 2016: Wholly owned subsidiary Granules Pharmaceticals Inc (GPI) enters into agreement to acquire 12.5% stake in US based USPharma.
• 2017: Granules India Limited featured in the list at 60th place in Fortune India's 2017 list of The Next 500 Companies.
• 2018-19: Granules Pharmaceuticals Inc. launched generic Methylergonovine tablets (Methergine) in partnership with Hikma Pharmaceuticals Plc.
• 2018-19: Granules Pharmaceuticals Inc. successfully launched Metformin XR and Methocarbamol under its own label.
• 2020: Granules India gets nod to set up subsidiary in Hyderabad.
• 2020: Granules India gets marketing approval from US FDA for Potassium Chloride Extended Release Tablets.
• 2021: USFDA approves ANDA filed by Granules India’s arm for Potassium Chloride Oral Solution.