US FDA Issues Five Observations at Zydus Lifesciences' Moraiya Plant in Gujarat

The US Food and Drug Administration issued five observations after inspecting Zydus Lifesciences' Moraiya facility in Gujarat, citing data integrity, quality control and manufacturing issues. NDTV Profit reported the observations, which followed an inspection conducted between October 5 and October 13, 2026. The facility accounts for about 45% of the company's US sales.

What the Moraiya Inspection Found

The US FDA flagged instances where microbial growth detected during testing was not accurately documented in laboratory records. The regulator raised concerns over an inadequate investigation into a metal shaving found in a tablet, an incident that had resulted in a Class II recall. The inspection identified instances where multiple batches that exceeded established assay control limits were released into the US market without adequate investigations to determine root causes.

The US FDA noted the absence of written procedures for identifying, investigating and reporting suspected or illegitimate drug products. The regulator flagged deficiencies in the verification of Fourier-transform infrared instruments used for raw material identification, with documented performance verification not carried out for three years. Another concern related to the continued reduction in testing of incoming raw materials despite previous failures to meet specifications, which was inconsistent with the company's established procedures.

Zydus Lifesciences is India's 4th-largest, vertically integrated pharmaceutical company, founded in 1952 and headquartered in Ahmedabad, developing and manufacturing APIs, branded generics, biosimilars, vaccines and novel drugs across India, the US, Europe, Latin America and more than 25 emerging markets.

Zydus Lifesciences' Recent Deal Activity

According to akta.pro company records, Zydus Lifesciences completed a $166.4 million acquisition of US-based Assertio Holdings in June 2026, gaining an FDA-approved specialty oncology asset and over 170 community oncology accounts. The same records show the company established a 50:50 joint venture, Zydus Sunshine Lifesciences, with Sunshine Healthcare Lanka in June 2026, committing up to $5 million for 50% equity to build a pharmaceutical manufacturing facility in Sri Lanka's Horana Export Processing Zone.

Earlier Zydus Lifesciences Regulatory Milestones

On October 21, 2026, Zydus Lifesciences received final USFDA approval for its Estradiol and Levonorgestrel transdermal system, eligible for 180-day CGT exclusivity, with expected annual US sales of $45.7 million and manufacturing at the Moraiya facility in Gujarat, ScanX reported. On October 5, 2026, Zydus Lifesciences and MSN Laboratories launched the first generic Riociguat tablets in the US, approved by the FDA in five strengths, according to ScanX. On October 1, 2026, Zydus Lifesciences and Sunshine Healthcare Lanka extended the closing of their 50:50 joint venture, Zydus Sunshine Lifesciences, to December 2026, ScanX reported.

What Comes Next for Zydus Lifesciences

The joint venture closing with Sunshine Healthcare Lanka is extended to December 2026, pending completion of condition precedents in the SSSHA.