Aurobindo Pharma Ltd on Tuesday said its wholly-owned arm Eugia Pharma Specialties Ltd has received final approval from the US health regulator for its generic version of Vasopressin injection
K Nithyananda Reddy, Vice-Chairman and Managing Director of the company said, investments in product portfolio continued at a healthy pace as reflected in the filings and launches in the quarter."
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Aurobindo Pharma on Tuesday said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and subsequently given a warning letter on June 20, 2019 by the USFDA, Aurobindo Pharma said in a regulatory filing. Subsequently, the company said it has responded to the warning letter and carried out the committed corrections and the USFDA authorities inspected the facility from July 25 to August 2, 2022. "At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related ..
Among select export-oriented shares, Aurobindo Pharma seems well placed on the charts with a potential upside of 9 per cent in the near term.
Aurobindo Pharma remains focused on developing complex and differentiated products in multiple areas to drive the next phase of growth
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The letter is in regards to certain disclosures made by the company on the ongoing USFDA audit of company's Unit-1 and observations made by the USFDA between the period 2019 to 2022
While valuations are now attractive, product approvals and progress on the injectable guidance are among key long-term term triggers
While valuations are now attractive, product approvals and progress on the injectable guidance are among key long term term triggers
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Aurobindo Pharma Ltd on Monday reported a 28 per cent decline in its consolidated net profit at Rs 576.14 crore in the fourth quarter ended March 2022.
Analysts at ICICI Securities expect Aurobindo Pharma's adjusted PAT to de-grow 30.4 per cent year-on-year (YoY) to Rs 557.90 crore in the March 2022 quarter.
Drug major Aurobindo Pharma on Wednesday said its wholly-owned subsidiary has received approval from the US health regulator to market anti-cancer medication Bortezomib for injection. Eugia Pharma Specialties has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market the product, a generic equivalent of Takeda Pharmaceuticals' Velcade for injection, the Hyderabad-based company said in a statement. The product, which is indicated for the treatment of multiple myeloma (cancer of plasma cells) and mantle cell lymphoma (cancer of lymph nodes), is being launched immediately, it added. According to IQVIA, the approved product has a market size of USD 1,172 million for the twelve months ending March 2022.
Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons
Deal is nonetheless a stepping stone in the drug firm's strategic plan to focus on domestic formulations market, where it aims to have Rs 1,000-cr sales in three years
Move marks Aurobindo's increasing focus on Indian market
The transaction comes into effect from April 1, 2022 and is expected to close by May 2022