Granules Consumer Health Clears USFDA Inspection with Zero Observation

Granules India reported that its subsidiary in the U.S., with step-down operations, Granules Consumer Health, LLC, has passed a Good Manufacturing Practice (GMP) inspection conducted by the U.S. Food and Drug Administration (FDA) with zero observations. This is the second FDA audit of the facility, the first being the March 2023 inspection, when a No Action Indicated (NAI) classification was assigned to the facility.

"Granules Consumer Health plays a critical role in our global operations as a packaging and distribution site. We process controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Achieving zero observations in this inspection reflects our unwavering focus on quality, safety, and regulatory excellence," said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.

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Granules Consumer Health is a front-end operation of Granules India in the U.S., where OTC products can be utilized, taking advantage of the manufacturing efficiencies, regulatory compliance, and supply chain of the company. The effective FDA inspection affirms the company to provide quality pharmaceutical products to the American market.

Industry pundits consider this accomplishment one of the milestones of the growth strategy of Granules India in the regulated market. Having strong compliance programs and a sound emphasis on quality, Granules will be in a good position to enhance its role in the very competitive pharmaceutical and OTC industry in the United States.

The zero-observation FDA clearance also indicates that Indian pharmaceutical firms are increasingly able to play up to international standards to provide healthcare products that are safe, effective, and reliable to the rest of the world. The performance of Granules Consumer Health highlights the changing position of India as a reliable ally in the pharmaceutical market in the world.