Wednesday, May 22, 2024

Granules India’s Facilities Receive Zero Observations in US FDA Inspections

Granules India Limited, a leading vertically integrated pharmaceutical company has completed the U.S. Food and Drug Administration’s (US FDA) Pre-Approval Inspection (PAI) and GMP audit for their Unit IV facility located at Visakhapatnam, Andhra Pradesh, India with zero 483 observations.

Recently, Granules India’s Jeedimetla facility located at Telangana, Hyderabad, India also successfully completed the US FDA’s surveillance inspection with zero 483 observations.

The Vizag facility was inspected by the US FDA from 26th June to 30th June, 2023 and the Jeedimetla facility from 19th June to 23rd June, 2023. The zero-observation outcome reflects the company’s robust quality management systems and commitment to excellence in its operations.

“We are proud of the successful completion of the US FDA surveillance inspections at our Vizag and Jeedimetla facilities with zero observations. This achievement is a testament to our unwavering commitment to quality and compliance. It reinforces our position as a trusted and reliable global pharmaceutical manufacturer.” said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India.

The Unit IV facility located at Visakhapatnam manufactures Active Pharmaceutical Ingredients (API) and the Jeedimetla facility manufactures Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates (PFIs).

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

Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service.

Amongst the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs), Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK.

The Company has 7 manufacturing facilities out of which 6 are 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.


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