Page 7 - Aurobindo Pharma

Aurobindo Pharma's arm to invest around Rs 300 cr for capacity expansion

Aurobindo Pharma on Thursday said its wholly-owned arm, CuraTeQ Biologics, plans to invest around Rs 300 crore on capacity expansion of biologics manufacturing facilities. The board of directors of CuraTeQ Biologics Pvt Ltd, at its meeting held on Thursday, approved the expansion of its operations by establishing another mammalian cell culture manufacturing facility of higher capacity to cater to the future requirements, Aurobindo Pharma said in a regulatory filing. "The capital expenditure for ramping up capacities is estimated to be around Rs 300 crore," it said, adding that the facility is likely to be fully operational by FY26. Further, the board also approved entering into contract manufacturing operations (CMO) for biologicals for effective utilisation of capacities. This would augment the business prospects in this area as the global biologics contract manufacturing demand is growing at 8-10 per cent and CuraTeQ will actively seek customers in CMO area, it added. The compan

Aurobindo Pharma subsidiary's plant gets one observation from USFDA

Aurobindo Pharma on Monday said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit. The US Food and Drug Administration (USFDA) conducted its Pre-Approval Inspection (PAl) and GMP (Good Manufacturing Practice) inspection from August 22-26 of Raleigh-based plant which has been set up for manufacturing MOl (Metered Dose Inhalers) and derma products, the Hyderabad-based drug firm said in a regulatory filing. The plant is owned by Aurolife Pharma LLC, a wholly-owned step down subsidiary of the company, it added. "At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues," Aurobindo Pharma said. The company will respond to the USFDA within the stipulated timeline, it added. As per 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

USFDA approves Aurobindo Pharma owned Eugia's generic Vasopressin injection

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

Aurobindo Pharma Q1 net profit down by 32% to Rs 520.5 cr; revenue up 9.4%

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."

Sensex up 515 pts, Nifty tops 17,650 on lower-than-expected US inflation

CLOSING BELL: Easing CPI figures reduced the probability of a 75-bps rate hike in the upcoming US FOMC meeting

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Stocks to Watch today: Uber has decided to put its entire 7.8 per cent stake in Zomato on the block, according to sources.

Aurobindo Pharma's Andhra unit gets Form 483 with 3 USFDA observations

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 ..

Rupee breaches 80: Watch out these levels on forex-sensitive Infy, IndiGo

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 to develop complex products, expand global footprint

Aurobindo Pharma remains focused on developing complex and differentiated products in multiple areas to drive the next phase of growth

Sensex, Nifty end flat after volatile session; metal, energy stocks shine

CLOSING BELL: M&M, Tech M, Dr Reddy's Labs, Reliance Industries, HCL Tech, and Tata Steel were the top gainers on the 30-pack index

Stocks to watch: Bajaj Auto, TVS Motor, Tata Steel, Cipla, JSW Steel, FRL

Stocks to watch today: Bajaj Auto approved buyback of shares worth up to Rs 2,500 crore; Moody's upgraded Tata Steel's outlook to 'positive' from 'stable'

Aurobindo Pharma receives Sebi's warning letter over ongoing USFDA audit

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

Near-term growth issues and cost pressure could impact Aurobindo Pharma

While valuations are now attractive, product approvals and progress on the injectable guidance are among key long-term term triggers

Near-term growth and cost challenges to weigh on Aurobindo Pharma stock

While valuations are now attractive, product approvals and progress on the injectable guidance are among key long term term triggers

Stocks to Watch: LIC, Delhivery, Sun Pharma, Vodafone Idea, IRCTC, SpiceJet

Stocks to Watch: Investors will react to LIC and Delhivery's Q4 numbers. The domestic GDP data for March quarter, slated to be released later today, will also be keenly monitored.

Aurobindo Pharma Q4 net profit falls 28% to Rs 576 cr; revenue dips 3%

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.

Aurobindo hits 2-year low; dips 11% in a week on USFDA's 6 observations

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.

Aurobindo Pharma gets USFDA nod to market generic cancer drug Bortezomib

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.

Aurobindo, Sun Pharma, Jubilant recall products in US market: USFDA

Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons

Aurobindo's Veritaz acquisition unlikely to add much value: Analysts

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