Granules India Ltd

Granules India Limited is a largescale vertically integrated company founded in March 18th, 1991 manufacturing Active Pharmaceutical Ingredient (API), Pharmaceutical Formulation Intermediate (PFI) and Finished Dosage (FD). With a strong presence across all three vertical, the company has created a leadership position in the offpatent drugs segment along with ensuring a strong presence in first line of defense products such as Paracetamol, Ibuprofen, Metformin and Guaifenesin. The company has a global presence across over 80 countries servicing over 300 customers. Granules India is the preferred supplier for some of the worlds leading pharma branded and generics companies. The company has one of largest PFI and single site FD facilities in the world. It is also home to one of the Worlds largest Paracetamol API facilities.Granules India has 8 manufacturing facilities, out of which six are located in India and two in the US. It also has two operational manufacturing units located in India and China through its joint venture entities. The company has 250 customers present across 60 countries around the globe. The companys research center at Pragathi Nagar, Hyderabad, spread across an area of 15,000 square feet, epitomizes the companys focus on research and development. It mainly focuses on fullscale generic API development.Incorporated as a private limited company in 1991, Granules India (GIL) was converted into a public limited company in Feb.93. It commenced its operations in Apr.91 as a merchant exporter of bulk drugs like paracetamol, guaifenesin and chloro pheniramine maleate. Since 1992, GIL concentrated on export of paracetamol powder. In Aug.94, GIL took over Triton Laboratories (TL), a group company from which GIL was procuring the drugs for exports. GIL also acquired a sick unit which was manufacturing bulk drugs, from the Andhra Pradesh State Financial Corporation (APSFC) in Mar.94. GIL implemented the ongoing project taken over from TL to manufacture bulk drugs like folic acid, salbutamol sulphate, brom pheniramine maleate and direct compression (DC) blends of paracetamol, through the process of granulation. The unit, an EOU, is located at Hyderabad, Andhra Pradesh. Commercial production of folic acid commenced in Aug.95. It came out with a public issue in Sep.95 to partfinance this project.The company completed expansion of Guaifenesin capacity from 100 Mts to 240 Mts per annum. Company had developing new products like Brom Pheniramine Maleate Chloro Pheniramine Maleate, is in process of developing new bulk drug for the export market. The Company set up a 100% marketing subsidiary in US to enhance its exposure in the large pharmaceutical market in the world. The Gagillapur plant commences its commercial production of Line II (installed capacity 3200 MT) which was commenced its July, 2003 and the remaining 4000 MTPA is expected to go on stream in the first half of 200304. The total project cost is Rs.30 crore.Granules India reported record sales of Rs100,167.99 Lakhs in 201314 compared to net sales of Rs 67,979.70 Lakhs in 201213, registering growth of 47.35%. The companys growth was driven by strong performance across all manufacturing facilities. The primary growth driver in FY 2014 was led by the companys commercialization of its Pharmaceutical Formulation Intermediates (PFI) and Finished Dosage expansion at its Gagillapur facility. The Company improved utilization in the newly expanded facility throughout the year and expects to continue improving utilization in the future. In addition, the API facilities continued to increase production which contributed to strong sales.In FY 2014, Granules India made its first acquisition by purchasing Auctus Pharma Limited (Auctus) by purchasing Auctus total 3,900,000 equity shares on 14 February 2014 on payment of Rs10,200 Lakhs as purchase consideration to the shareholders of the Auctus Pharma Limited. Auctus Pharma Limited is the manufacturer and seller of bulk drugs and drug intermediates. The acquisition of Auctus fits into companys strategy of being a fully integrated manufacturer while diversifying its product portfolio by adding highvalue products with significant market demand.During FY 2014, the company commercialized its expansion at the Gagillapur facility. The expansion involved a capacity expansion in the PFI and Finished Dosage facilities. The expansion mainly focused on efficient design and output in terms of material transfer and automation. During the year, the company received customer approvals for both expansions and capacity utilization increased accordingly. The company also continued construction of a new central warehouse at its Gagillapur plant in FY 2014. During the year under review, the company opened up a 10,000 sq. ft. RD Center in Hyderabad.During the year ended 31 March 2015, Granules India enhanced PFI capacity by adding 4000 Tons per annum in the Gagillapur facility which will help to produce PFIs and formulations in the year to come. During the year, the company inaugurated manufacturing facility at Visakhapatnam for highvalue APIs and intermediates. The company also expanded clean room facility at Visakhapatnam plant which will enable it to produce and sell more APIs. During the year, the company has reinforced its fundamental strength of FDA complied facilities by successfully completing the US FDA audits at Bonthapally and Gagillapur facilities with no observations. During the year, the company received ISO 14001 and OHSAS 18001 certification for facilities at Jeedimetla and Gagillapur. During the year, Social Accountability Audit for the companys Gagillapur plant was completed successfully. During the year under review, the company started the commercial sale of Abacavir, an antiretroviral drug, developed by the companys inhouse RD unit.Granules Pharma Inc. was incorporated as a 100% subsidiary of the company in the US to focus on formulation and RD of value added product forms. The company ventured into direct supply of store brand OTC products to US retail chains during the year. During the year, the High Court of Judicature at Hyderabad for the state of Telangana and the state of Andhra Pradesh, vide its order dated 23 September 2014 approved the Company Petition no. 144 of 2014 filed by Auctus Pharma Ltd., a wholly owned subsidiary of Granules India, for the Scheme of amalgamation of Auctus Pharma Ltd. with the company. Consequent to the said High Court order, Auctus Pharma Ltd. was amalgamated with the company on 13 November 2014, being the effective date, with effect from 1 April 2013, i.e. appointed date. Granules India successfully turned around Auctus Pharma Limited during the fourth quarter of FY 2015. In FY 201415, Granules India crossed Rs 1200 crore in revenue.With a view to broad base the investor base by encouraging the participation of the small investors and also to increase the liquidity of equity shares, the company, with the approval of the shareholders, has subdivided each equity share of face value of Rs.10/ of the company into 10 equity shares of face value Rs.1/ each during the year under review with effect from 24 March 2015.During the year ended 31 March 2016, Granules India started construction of 7,000 TPA Metformin and 2,000 TPA Guaifenesin API block at its Bonthapally plant. It also started construction of green field multipurpose API facility in Vizag and construction of 3,600 TPA PFI block at its Gagillapur plant. During the year under review, the formulation facility at Virginia in the US was renovated. During the year under review, commercial production started from CRAMS facility in Vizag. During the year under review, the company received ANDA approval for Ibuprofen Rx.During the financial year 201516, Granules India enhanced Paracetamol API capacity at Bonthapally plant by 3,000 metric tonnes per annum.In FY 2016, Granules India crossed Rs 1400 crore in revenue.The company allotted 1,13,50,230 equity shares of RS. 1/ each to the promoters upon exercise of an equal number of warrants vested in them pursuant to the approval of the members obtained during the financial year 201516.The draft scheme of amalgamation of Granules Indias subsidiary M/s. GIL Lifesciences Private Limited with the company was approved by the Board of Directors of the company, subject to approval of the High Court of Judicature at Hyderabad for the State of Telangana and the State of Andhra Pradesh.During the year ended 31 March 2017, US FDA and INFARMED audit were completed for Granules Indias Gagillapur facility. Also, the US FDA carried out inspection at the companys joint venture facility in Vizag. There were seven observations, which the company has responded and is awaiting clearance from US FDA.During the year under review, the company filed 3 ANDAs from its Hyderabad facility which will help increase its core business portfolio. The company has also filed 2 ANDAs from its Virginia facility. These are first set product filling from Virginia facility towards building portfolio for the US market.During the year under review, the company filed 3 DMFs from its Vizag site, which will be used building future revenue from new API business. FY 2017 was the first full year of operation of Granules OmniChem Private Limited (CRAMS business) which delivered substantial rise in revenue. Granules OmniChem Private Limited is an equal joint venture between Granules India and Ajinomoto OmniChem.During the year under review, the company received the establishment Inspection Report from the USFDA for its Jeedimetla plant. During the year under review, the company received the license from the Drug Enforcement Agency of the United States for its Virginia facility in the US, which will enable it to store and develop narcotics products.Granules Indias whollyowned foreign subsidiary Granules Pharmaceuticals. Inc. (GP Inc.) entered into an agreement during the year under review with USpharma Limited to acquire 12.5% of its equity. This investment will also enable the company to participate in the product selection and have the first right of refusal to market the select products which are under development by them. USpharma Limited in collaboration with its manufacturing partners have submitted 5 ANDAs with Para IV and Para III certifications, out of which 4 ANDAs have already been outlicensed to GP Inc. exclusively for the marketing and distribution of the products in the United States after final approval from US FDA, pursuant to the agreement entered with it for productinlicensing.Granules India has initiated expansion of API capacities for in Bonthapally for Paracetamol, Metformin and Guaifenesin. In FY 2017, Granules India allotted 114,01,000 equity shares of Rs 1/ each to the promoters upon exercise of an equal number of warrants vested in them pursuant to the approval of the shareholders obtained during the financial year 201516.During the year ended 31 March 2018, US FDA has completed site inspection for Granules India facilities located at Gagillapur and Jeedimetla. US FDA had issued Establishment Inspection Report for both the facilities. During the year under review, seven ANDAs were filed by the companys whollyowned foreign subsidiary located in Virginia, USA Granules Pharmaceuticals. Inc. (GP Inc.). During the year under review, US FDA has completed site inspection for the facility located at Virginia and issued Establishment Inspection Report.In FY 2018, Granules India initiated commercial production of Metaformin and Paracetamol API at its Bonthapally facility post completion of its expansion plan initiated during FY 2017. The new PFI block at Gagillapur for 6000 MTA was commercialised during the year. The company filed 4 US DMFs during the year, increasing the total USDMF filings with the USFDA to 21. One new CEP was filed by the company in 201718, taking the total CEPs filed with EDQM to 11. Total EDMFs filed increased to 6 out of which 2 were filed in FY 2018.Out of 20 ANDA filings with the U.S. FDA, Granules India successfully received approval for 7 ANDAs in FY 2018. During the year under review, the company received first product approval for USpharma portfolio.Granules India allotted 24,754,792 equity shares of Rs 1/ each through Qualified Institutions Placements (QIP) pursuant to the approval of the members obtained during the financial year 201718.During the year 2019, the Companys subsidiary, Granules Pharmaceuticals Inc. launched generic Methylergonovine tablets (Methergine) in partnership with Hikma Pharmaceuticals Plc. and also launched Metformin XR and Methocarbamol under its own label.The Company filed 12 ANDAs, 2 USDMFs, 2 CEPs during the year 2019.As on 31 March 2020,the company has 3 subsidiaries and one joint venture company under its fold.The company has invested Rs 40 crore as a part of maintenance CAPEX towards enhancing capacities at Gagillapur facilities in Hyderabad.During the FY2020,the company received consideration of Rs 222.19 crore on disinvestment of nonstrategic JVs Granules Biocause and Granules OmniChem. The company also filed 44 ANDAs and 20 DMFs.During the year ended March 31, 2020, the Company has entered into a definitive agreement to divest its entire 50% shareholding in GranulesBiocause Pharmaceutical Co. Ltd, for a consideration of Rs, 112.34 crore(RMB 109 million). The Company also entered into a definitive agreement to divest its entire 50% shareholding in Granules Omnichem Private: Limited, for a consideration of Rs. 109.85 crore.The Board of Directors at their meeting held on 21 January 2020 approved a buyback proposal, subject to the approval of shareholders for purchase by the company of up to equity shares of 12,500,000 of face value Re 1 each (representing 4.92% of total paidup equity capital) from shareholders of the company at a price of Rs 200 per share. During the quarter ended 30 June 2020, the Company has concluded the buyback of 7,101,374 equity shares at a price of Rs 200 per equity share (Buyback) as approved earlier by the Board of Directors at their meeting held on 21 January 2020.During the year ended 31 March 2021, Granules Pharmaceuticals Inc., had announced the voluntarily recall of 12 batches of Metformin Hydrochloride Extended Release tablets USP, 750 mg. Out of the 12 batches, the recall of 1 batch was due to the detection of N Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake limit. The remaining 11 batches, which were well below the limit, were recalled by the Company out of caution. In year 2022, the Company completed the largest single manufacturing site for Multiple Unit Pellet System (MUPS) at its Gagillapur facility. It completed expansion capacity for manufacturing multiple APIs at Unit V, Visakhapatnam.The Company launched new greenfield packaging facility in Virginia, USA in 202223. It made substantial enhancements to paracetamol API capacity and anticipate a surge in MUPS block utilization for the upcoming financial year. The Company established Granules CZRO, a whollyowned subsidiary of Granules India Limited in 2023. During the year 202223, approximately 20% of the total energy consumed at the Formulation unit located at Gagillapur, Hyderabad was from Solar Energy.