Cipla (CIPLA) — Announcement

1 Announcement 🔴 High Importance Neutral 📄 PDF

Cipla announced that the US FDA granted final approval for its Nilotinib Capsules (50, 150, 200 mg) targeting Philadelphia chromosome-positive chronic myeloid leukemia, with a planned US launch in FY 2025-26, marking a key regulatory milestone for its oncology portfolio.

2 Announcement Neutral 📄 PDF

Cipla disclosed that its wholly owned subsidiary Sitec Labs received two USFDA Form 483 observations following a cGMP inspection at its Mahape facility in February 2025, signaling potential regulatory scrutiny but reaffirming commitment to remediation.

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About Cipla Limited (CIPLA)

Healthcare · Pharmaceuticals & Biotechnology · Listed on NSE

Market Cap: ₹1,15,682.55 Cr P/E: 25.4 ROE: 14.6% ROCE: 19.4%

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Source: Stock Announcements. Analysis by StockFin.ai. For informational purposes only — not investment advice.

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