Business EconomyPosted at: Nov 8 2024 6:12PM


Granules India receives EIR from US FDA for Unit V Facility

Hyderabad, Nov 8 (UNI) Granules India Limited, a leading pharmaceutical manufacturing company, on Friday announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Unit V facility located at Jawaharlal Nehru Pharma City (JNPC), in Anakapalli district of Andhra Pradesh.
The inspection was conducted by the US FDA from April 8 to April 12, 2024, the Pharma company said in a release here.
The US FDA inspection classified the facility as "No Action Indicated" (NAI), indicating compliance with current Good Manufacturing Practices (cGMP) standards and confirming that no further regulatory action is required.
This outcome reflects the facility's high standards in the production of Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs) for both oncology and non-oncology therapeutic areas.
During the inspection, the FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit, which concluded with zero Form 483 observations, underscoring Granules India’s commitment to stringent quality control, regulatory compliance, and operational excellence.
"The successful completion of this US FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our unwavering commitment to maintaining the highest quality standards in our manufacturing operations," said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director.
Granules India’s Unit V facility plays a pivotal role in the company’s mission to deliver high-quality and accessible pharmaceuticals globally by prioritizing regulatory compliance, operational excellence, and value delivery to stakeholders.
The company remains dedicated to producing top-quality pharmaceutical products that meet global health standards.
UNI KNR CS1811
Please log in to get detailed story.
Tags: #Granules India receives EIR from US FDA for Unit V Facility
More News

OMRON, Tricog launch AI-powered KeeboHealth platform in India

10 Jul 2025 | 1:01 PM

Bengaluru, July 10 (UNI) In a major stride towards transforming cardiac care, OMRON Healthcare and Tricog Health on today jointly launched KeeboHealth, an AI-powered remote health monitoring platform designed to combat India’s growing heart disease burden and align with OMRON's global ‘Going for Zero’ vision—aimed at achieving zero cardiovascular events.

see more..

Starlink receives nod from IN-SPACe to operate in India

10 Jul 2025 | 11:57 AM

New Delhi, July 10 (UNI) The Indian National Space Promotion and Authorisation Centre (IN-SPACe), the country's premier nodal agency overseeing space programmes, has approved a five-year license for Starlink to resume its commercial operations in India.

see more..

Linda Yaccarino steps down as CEO of 'X'

10 Jul 2025 | 10:37 AM

San Francisco, July 10 (UNI) CEO of social media platform 'X' Linda Yaccarino, has formally announced the decision to step down from her role after two years working under Elon Musk.

see more..
IndiGo Ventures takes flight with first close of its fund at Rs 450 crore; makes debut investment in Jeh Aerospace

IndiGo Ventures takes flight with first close of its fund at Rs 450 crore; makes debut investment in Jeh Aerospace

10 Jul 2025 | 8:02 AM

Hyderabad, July 9 (UNI) IndiGo Ventures, the corporate venture capital arm of India’s preferred airline IndiGo, today announced the first close of its maiden fund at Rs 450 crore.

see more..

UP Excise Investors’ Summit attracts Rs 3,600 Crore investment proposals, showcases growth in Alcohol-based industries

10 Jul 2025 | 12:51 AM

Lucknow, July 9 (UNI) In a major push to boost investments in the alcohol-based industries, the Uttar Pradesh Excise Department, in collaboration with Invest UP, attracted investments worth Rs 3,600 crore during a day long Excise Investors’ Summit here today.

see more..