Zydus Gets OAI Classification from US FDA for Gujarat Facility Inspection

Zydus Lifesciences announced on Thursday, July 18, that it has received a report from the United States Food and Drug Administration (USFDA) about an examination of its injectables manufacturing plant in Jarod, near Vadodara, Gujarat, India.

Key Takeaways of Zydus OAI Classification

• Zydus Lifesciences has received an OAI classification for its Jarod facility.
• The inspection occurred between April 15 and April 23, 2024, in Jarod, Gujarat, India.
• The company is committed to addressing the issues identified and will collaborate with the USFDA to resolve the regulatory status promptly.

‘We wish to inform that the Company has received a report from the United States Food and Drug Administration (“USFDA”) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat, India between April 15 and April 23, 2024,’ the company said in an exchange filing on Thursday. 

The company released a statement informing that the inspection, conducted between April 15 and April 23, 2024, has resulted in an “Official Action Indicated” (OAI) classification for the facility. 

The company also stated that it will work closely with the agency to resolve the regulatory status of this facility expeditiously.

About Zydus Lifesciences Limited

Zydus Lifesciences Limited (formerly Cadila Healthcare Limited), a major Indian pharmaceutical corporation, is a fully integrated global healthcare provider. With extensive domain understanding in healthcare, it possesses significant capabilities across the pharmaceutical value chain. 

Zydus has acquired a reputation among Indian pharmaceutical businesses for delivering comprehensive and full healthcare solutions, including formulations, active pharmaceutical ingredients, animal healthcare products, and wellness goods. One of Zydus' distinguishing traits is its extensive history and ancestry. 

The corporation originated in the 1950s. Mr. Ramanbhai B. Patel (late) launched the firm in 1952, as a first-generation entrepreneur and doyen in the area of Indian pharmaceuticals. Cadila Healthcare was created in 1995 as a result of the organisation's restructuring under the Zydus group. From a humble revenue of Rs 250 crores in 1995, the group saw considerable financial development, reaching a turnover of more than Rs 19,500 crores in FY24.

Zydus continues to develop with an unwavering commitment to meet unmet healthcare needs, remaining true to its brand promise of being devoted to life in all its aspects. Simultaneously, it commits to its purpose of promoting healthier, happier communities across the world.

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