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Top News In Form 483 Today - Breaking & Trending Today

Eye on Pharma: Eylea Biosimilar Suspension; New FDA Labeling Guidance; Alvotech Reinspection

Samsung Bioepis suspends development for its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives a Form 483 after the FDA reinspected its Iceland-based manufacturing facility. ....

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ipca lab share price: Ipca Labs falls 3% after USFDA issues Form 483 to API unit

Shares of Indian pharmaceutical company, Ipca Laboratories, fell by 3% after the US Food and Drug Administration (USFDA) issued a Form 483 report, citing 11 observations of its API manufacturing facility situated in Ratlam. Form 483 is issued when an inspector has found conditions that could violate FDA regulations. Ipca said it takes quality and compliance issues seriously and will submit a response in the prescribed time. Trendlyne data showed that the stock s day RSI (14) is at 57.8, while the MACD is above its center and signal line, which is a bullish indicator. ....

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Lupin shares fall 4% after USFDA issues Form 483 for Pithampur plant

Lupin shares plunged 3.18% to Rs 106.50 against the previous close of Rs 110 on BSE. Market cap of the firm fell to Rs 10,970 crore ....

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Fierce Pharma Asia—Takeda's patent cliff and rare disease setback; FDA's censure of Sun, Aurobindo

Takeda is preparing for the patent loss of its third-largest product but called it quits on a rare disease therapy. ....

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Fierce Pharma Asia—Merck's former China head returns

Merck's former China head will return to the Big Pharma to lead international human health operations after a short stint at a Chinese company. ....

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