Cipla Shares Plunge 4.5% as USFDA Flags Compliance Gaps at Key Supplier Pharmathen

• Cipla shares dropped 4.5% in Mumbai after USFDA cited compliance issues at its Lanreotide supplier, Pharmathen International SA.
• USFDA issued a Form 483 to Pharmathen's Sapes, Rodopi facility in Greece, citing gaps in contamination controls, aseptic processes, and building conditions.
• Pharmathen is a critical third-party manufacturer for Cipla's generic Lanreotide injection, approved in May 2024 for the US market.
• The regulatory concerns raise fears of potential supply disruptions for Cipla's important complex injectable, which has limited competition.
• Somatuline Depot, the brand-name equivalent, recorded $898 million in US sales, highlighting the commercial significance for Cipla.

Why It Matters: USFDA compliance flags at Cipla's key supplier Pharmathen caused Cipla shares to fall, raising supply concerns.