Granules India Ltd. — Capital/Financing Update 2021

Feb 17, 2021

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Press Release For Immediate Release

Granules India Limited announces approval of Potassium Chloride ER Capsules USP, generic - equivalent of Micro K ER Capsules of Nesher Pharmaceuticals (USA) LLC

Date: 17[st] February, 2021

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg). It is bioequivalent to the reference listed drug product (RLD), Micro-K Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. The product would be manufactured at our Hyderabad facility and is expected to be launched shortly.

“We are pleased to announce approval of Potassium Chloride Capsule product within first review cycle of 10 months from filing date. This is fourth ANDA approval in our Potassium Chloride product basket.” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval.

Potassium Chloride is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis.It is also indicated for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states.

Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).

Potassium Chloride ER Capsule products had U.S. sales of approximately $43 million for the most recent twelve months ending in December 2020 according to IQVIA Health.

CIN: L24110TG1991PLC012471 / Granules India Limited: 2[nd] Floor, Block 3, My home hub Madhapur, Hyderabad 500081

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About Granules India Ltd. (BSE: 532482, NSE: GRANULES)

Granules India is a growing pharmaceutical manufacturing company with best-in-class facilities and is committed to operational excellence, quality and customer service. The Company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice. Granules support customers with unique value, extensive product range, and proactive solutions. The Company’s global presence extends to over 250 customers in 60 countries through offices in India, U.S., and U.K. The Company has 6 manufacturing facilities out of which 5 are located in India and 1 in USA. Five of these have regulatory approvals from the USFDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

Investor Contacts:

Sandip Neogi Chaitanya Tummala Chief Financial Officer Company Secretary 040-30663563 040-30663614 sandip.neogi@granulesindia.com chaitanya.tummala@granulesindia.com

Safe Harbor:

This document is to provide the general background information about the Company’s activities as at the date of the release. The information contained herein is for general information purposes only and based on estimates and should not be considered as a recommendation that any investor should subscribe / purchase the company shares. The Company makes no representation or warranty, express or implied, as to, and does not accept any responsibility or liability with respect to, the fairness, accuracy, completeness or correctness of any information contained herein.

This release may include certain “forward looking statements”. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currencies, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global pharmaceuticals industries, increasing competition, changes in political conditions in India or any other country and changes in the foreign exchange control regulations in India. Neither the company, nor its directors and any of the affiliates or employee have any obligation to update or otherwise revise any forward-looking statements. The readers may use their own judgment and are advised to make their own calculations before deciding on any matter based on the information given herein.

No part of this release may be reproduced, quoted or circulated without prior written approval from Granules India Limited.

CIN: L24110TG1991PLC012471 / Granules India Limited: 2[nd] Floor, Block 3, My home hub Madhapur, Hyderabad 500081