Sun Pharmaceutical Industries' subsidiary, Taro Pharmaceutical Industries, has recalled over 17,000 units of an antifungal medication in the United States due to manufacturing deficiencies, according to the US Food and Drug Administration (USFDA).

Recall Details

The USFDA's latest Enforcement Report reveals that the Hawthorne-based company is recalling 17,664 units of Ciclopirox Shampoo, an antifungal medication used to treat seborrheic dermatitis. This skin condition causes dry, flaky, and itchy skin symptoms.

The company initiated the Class II nationwide recall on December 9 due to "Failed Impurity/Degradation specifications," as stated by the USFDA. According to the regulatory authority, a Class II recall is implemented when the use of or exposure to a violative product may cause temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

Company Background

Sun Pharmaceutical Industries completed the merger of Taro Pharmaceutical Industries in a deal valued at $347.73 million last year. Following this transaction, Taro became a private company and is now wholly owned by Sun Pharma. The Indian pharmaceutical giant has been the majority shareholder of Taro since 2010.

Taro focuses primarily on dermatology and produces a comprehensive range of prescription and over-the-counter products. The company's specialization in dermatological treatments aligns with Sun Pharma's broader pharmaceutical portfolio.

Industry Context

Indian pharmaceutical companies play a significant role in supplying medications to US residents. According to industry data, four out of ten prescriptions filled in the United States in 2022 were supplied by Indian pharmaceutical companies, highlighting the substantial contribution of Indian firms to the American healthcare system.

Sun Pharmaceutical Industries' Baska manufacturing facility has received an Official Action Indicated (OAI) status classification following a US Food and Drug Administration (FDA) inspection. The company disclosed this regulatory development through an official intimation filed under Regulation 30 of SEBI regulations on December 18.

Inspection Timeline and Classification

The FDA conducted a comprehensive inspection at Sun Pharma's Baska facility, which concluded with the OAI classification. This regulatory status indicates that the FDA identified objectionable conditions or practices during their review that may warrant further regulatory action or monitoring.

Operational Continuity Maintained

Despite the OAI classification, Sun Pharmaceutical confirmed that production activities at the Baska facility remain operational. The company continues to manufacture and supply approved products to the US market, indicating that the regulatory issues identified do not warrant an immediate halt to operations.

The pharmaceutical manufacturer emphasized its commitment to maintaining supply chain continuity for its US market operations while simultaneously addressing the regulatory concerns raised during the FDA inspection.

Regulatory Compliance Commitment

In its official communication to stock exchanges, Sun Pharma stated its dedication to working with the regulator to achieve fully compliant status. The company is actively addressing the issues identified during the FDA inspection to resolve the OAI status and restore full regulatory standing.

The regulatory intimation was signed by Anoop Deshpande, Company Secretary and Compliance Officer, demonstrating the company's formal acknowledgment of the regulatory development and its commitment to transparency with stakeholders.