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Zydus Lifesciences gets nod to manufacture, market 50mg Indomethacin suppositories

03 Aug 2023 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Indomethacin suppositories, 50mg. Zydus’ Indomethacin suppositories, 50 mg is the generic version of the Reference Listed Drug (RLD) Indocin suppositories. The company has been granted a CGT designation by the USFDA for its Indomethacin suppositories. Zydus’ Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.

Indomethacin suppositories is a non-steroidal, anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis. Indomethacin suppositories 50mg had an annual sale of around $95 million in the United States (IQVIA MAT April-2023).

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

Zydus Lifesciences Share Price

942.55 3.35 (0.36%)
17-Apr-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1675.20
Dr. Reddys Lab 1235.40
Cipla 1238.30
Zydus Lifesciences 942.55
Lupin 2324.25
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