Shares of Sun Pharmaceutical Industries Ltd fell 3% on Thursday, 18 December, after the US Food and Drug Administration examined the company’s facilities.

The US Food and Drug Administration (US FDA) inspected Sun Pharma’s Baska facility from 8 September to 19 September 2025, according to an exchange filing. According to the regulator, the inspection conclusion was designated as Official Action Indicated (OAI).

The company stated that it will continue to manufacture and supply permitted items from the facility to the US market while working closely with the government to achieve complete compliance.

Sun Pharma counts its Baska facility among its most important plants, especially for developing complex generics. However, the recent OAI classification reduces the likelihood of any near-term upside from its generic portfolio.

Regulatory scrutiny continues at other Sun Pharma sites as well. Authorities have kept the Halol plant under import alert since June 2022 and issued another OAI classification after an inspection in June 2025. Regulators also issued a consent decree or non-compliance letter to the Mohali facility in 2023.

Despite these challenges, the Mumbai-based drugmaker expects its India business to outpace market growth, driven by a strong focus on key therapies and brand building, Chief Financial Officer Jayashree Satagopan said.

Sun Pharma operates as a speciality generics company with a presence across innovative medicines, generics, and consumer healthcare. It ranks as India’s largest pharmaceutical company and maintains a strong footprint in the US and other emerging markets. Innovative Medicines contributes about 20% of its revenue, led by products in dermatology, ophthalmology, and onco-dermatology.

At 12:53 pm, the shares of Sun Pharma were trading 3.05% higher at Rs 1,738.20 on NSE.

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