Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Granules India Ltd. Capital/Financing Update 2021

Dec 28, 2021

60224_rns_2021-12-28_c12d7097-07e7-454b-a57a-510d9ae31cd1.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

==> picture [150 x 45] intentionally omitted <==

REGISTERED OFFICE

GRANULES INDIA LTD., 2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad – 500 081, Telangana, INDIA. Tel: +91 40 69043500, Fax: +91 40 23115145, [email protected], www.granulesindia.com CIN: L24110TG1991PLC012471

`

Dated December 28, 2021

To, National Stock Exchange of India Limited BSE Limited Symbol: NSE: GRANULES; BSE: 532482

Sub: Press Release

Dear Sir,

We are herewith enclosing the press release given by the Company.

This is for your information and dissemination to the members of the exchange.

Thanking You.

Yours sincerely,

For GRANULES INDIA LIMITED

==> picture [84 x 84] intentionally omitted <==

==> picture [182 x 36] intentionally omitted <==

CHAITANYA TUMMALA (COMPANY SECRETARY & COMPLIANCE OFFICER)

Press Release

==> picture [159 x 47] intentionally omitted <==

For Immediate Release

Granules Pharmaceuticals Inc., Receives ANDA Approval for Prazosin Hydrochloride Capsules

Hyderabad, 28 December 2021 : Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, for Prazosin Hydrochloride Capsules, USP 1mg, 2mg & 5mg. It is bioequivalent to the reference listed drug product (RLD), Mini plus capsules 1Mg, 2Mg & 5 Mg of Pfizer Inc. The product would be available for the US market shortly.

Commenting on the approval Ms. Priyanka Chigurupati, Executive Director, GPI , said “ We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market.

Granules now has a total of 46 ANDA approvals from US FDA (44 Final approvals and 2 tentative approvals).

The current annual U.S. market for Prazosin Hydrochloride 1mg, 2mg, 5mg strengths is approximately $54 million, according to IQVIA/IMS Health.

END

CIN: L24110TG1991PLC012471 / Granules India Limited: 2[nd] Floor, 3[rd] Block, My Home Hub, Madhapur, Hyderabad- 500081

==> picture [159 x 47] intentionally omitted <==

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

Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service. We are among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Our products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 75+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

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 employees 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.

Investor Contacts:

Krishna Raghunathan Chaitanya Tummala Vice President – Finance and Investor Relations Company Secretary 040-69043573 040-69043614 [email protected] [email protected]

CIN: L24110TG1991PLC012471 / Granules India Limited: 2[nd] Floor, 3[rd] Block, My Home Hub, Madhapur, Hyderabad- 500081