Aurobindo Pharma

Aurobindo Pharma, Glenmark, and Zydus recall products in US over mfg issues

Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based drug maker, is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths. The New Jersey-based firm is recalling the product due to "GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit," the US health regulator said. The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling around 90,000 bottles of Diltiazem Hydrochloride extended-release capsules (multiple strengths) in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Diltiazem Hydrochloride ...

Nifty Pharma jumps over 2%: Analysts decode the drivers behind the rally

Individually, Cipla soared up to 3.68 per cent to hit an intraday high of Rs 1,547.70 per share, while Sun Pharma soared up to 3.30 per cent to hit an intraday high of Rs 1,791.60 per share

Why has Aurobindo Pharma stock gained 3% in trade today, November 25?

The collaboration and licencing agreement is set to span three to five years and focuses on the joint development of specific products within the respiratory therapeutic area, Aurobindo Pharma said

Oversold Alert: 5 stocks with RSI around 15; Colgate tests 20-year support

Asian Paints, Aurobindo Pharma, AIA Engineering, Delhivery and Colgate-Palmolive stocks were trading in oversold zone, the daily chart shows. Here are the key levels to track.

Aarti Ind, Auro Pharma, Trent stocks see short build-up; trading guide here

F&O data shows, on Friday Aarti Industries, Aurobindo Pharma and Trent saw a dip in share price alongside rise in open interest; thus implying short build-up at these counters.

Aurobindo Pharma subsidiary gets 10 observations from USFDA for API plant

Aurobindo Pharma on Monday said the US health regulator has issued 10 observations after inspecting the API facility of its subsidiary in Telangana. The US Food and Drug Administration (USFDA) inspected Unit-II, an active pharmaceutical ingredients (API) manufacturing facility of Apitoria Pharma, a wholly-owned subsidiary of the company, in Sangareddy district from September 23-27, 2024, the Hyderabad-based drug maker said in a regulatory filing. The inspection closed with 10 observations, it added. The observations are procedural in nature and will be responded to within the stipulated time, the drug maker stated. Shares of Aurobindo Pharma on Monday ended 3.16 per cent down at Rs 1,462 apiece on BSE.

Aurobindo Pharma share down 4% as arm gets 10 observations from USFDA

Aurobindo Pharma's subsidiary Apitoria Pharma has received 10 observations from the USFDA for its API manufacturing facility in Telangana

Aurobindo to acquire remaining 49% stake in GLS Pharma for Rs 22.5 crore

Aurobindo Pharma Ltd on Wednesday said it will acquire the balance 49 per cent stake in GLS Pharma Ltd for Rs 22.5 crore to make the latter a wholly-owned subsidiary. The company has entered into a binding agreement on September 18, 2024, with GLS Pharma Ltd and its promoters for acquisition of remaining 5,90,361 equity shares of Rs 10 each amounting to 49 per cent stake for a purchase consideration of Rs 22.5 crore. The shares are being acquired at a price of Rs 381.12 per share, Aurobindo Pharma said in a regulatory filing. "This acquisition is undertaken to hold the entire ownership of GLS by the company," it said, adding that the transaction is estimated to be completed before December 31, 2024. Aurobindo acquired a 51 per cent stake in GLS Pharma from promoters Suresh Pathak and his family members on June 17, 2022. GLS is engaged in oncology products, which include orals and injectables used in chemotherapy for solid malignancies, chemotherapy for hematological malignancies an

Aurobindo Pharma arm receives EIR from USFDA for Andhra Unit; stock down 2%

Aurobindo Pharma shares fell following the news that the US Food and Drug Administration has issued the Establishment Inspection Report (EIR) for the new injectable facility of Eugia Steriles

Aurobindo, others recall products in US market over production issue: USFDA

Drug makers Aurobindo Pharma, Glenmark and FDC are recalling products in the US due to manufacturing issues, as per the US Food and Drug Administration (USFDA). Aurobindo Pharma USA Inc -- a unit of Hyderabad-based drug major -- is recalling 240 bottles of pain-relieving medication Healthy Living Acetaminophen, Aspirin (NSAID) and caffeine tablets. As per the latest enforcement report of USFDA, the company is recalling the affected lot due to "Missing Label". Some bottles are missing the manufacturer's label that includes the drug facts information, the US health regulator said. The New Jersey-based Aurobindo Pharma USA Inc initiated the Class 1 recall on July 11, it said. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, produced at a Madhya Pradesh plant, due to "Failed Dissolutio

USFDA pulls up Eugia for manufacturing lapses at its Telangana plant

The US health regulator has pulled up Aurobindo Pharma's subsidiary Eugia for manufacturing lapses at its Telangana-based plant. In a warning letter to Eugia Pharma Specialities CEO Yugandhar Puvvala, the US Food and Drug Administration (USFDA) pointed out that the company failed to ensure the accuracy of data for production and process simulation. "Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards," USFDA stated. The US health regulator said it inspected the Patancheru (Mandal), Sangareddy, Hyderabad-based plant from January 22 to February 2, 2024. "You failed to ensure the accuracy of data in records for both production and process simulations (media fills)," USFDA noted. Besides, the operators also falsified environmental monitoring records for the multiple aseptic filling lines, including for viable active air samples and non-viable particle counts which

Aurobindo Pharma to commercialise China plant in 3rd quarter of FY25: CFO

Aurobindo Pharma expects its China facility to commence production in the next quarter with full-scale output anticipated only in the next fiscal year, according to Chief Financial Officer Santhanam Subramanian. The Hyderabad-based drug major plans to start a small volume roll out in the November-December period and expects to ramp it up in the January-March quarter of the next year. "Our China plant is expected to be commercialised from Q3 FY25, and the ramp up is expected from Q4 FY25," Subramanian said in an analyst call. The full-fledged volume production will start at the facility in FY26, he stated. "We are trying to do some filings for China as well as for the US. So all this will take the China revenue potential up in the coming years. This year, we will see only a small volume and value," Subramanian stated. He noted that the company is also on track with respect to large-scale commercialisation of Pen-G (penicillin). The company is hopeful to ramp up production signific

Aurobindo Pharma arm gets warning letter from USFDA for Telangana unit

Aurobindo Pharma Ltd on Friday said its arm Eugia Pharma Specialities Ltd received a warning letter from the US health regulator for its formulations manufacturing unit in Telangana. Earlier in May, the company had stated that Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary, received Official Action Indicated (OAI) status by the US Food and Drug Administration (USFDA). "Subsequent to OAI, the unit has received a warning letter," Aurobindo Pharma said in a regulatory filing. It did not elaborate on the details of the warning by the regulator. "There is no impact on the existing supplies to the US markets," the company said. Aurobindo Pharma said it remains committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis. The USFDA had conducted an inspection at Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities Ltd, located at Pashamylaram, Patancheru Mandal, ..

Aurobindo Pharma stock tanks 6% after unit gets warning letter from USFDA

The drop in the share price came after the company announced that its' arm Eugia Pharma Specialties' Unit-III received a warning letter from United States Food and Drug Administration (USFDA).

TVS Motor, Aurobindo Pharma: Top picks by Chandan Taparia of Motilal Oswal

On the daily chart TVS Motor's price has broken out on the upside from an ascending triangle with higher-than-average buying volumes

Aurobindo Pharma hits lifetime high as analysts make bull case on growth

Shares of Aurobindo Pharmaceuticals soared as much as 4.96 per cent, hitting their all time high at Rs 1532.85 per share on the BSE in Tuesday's intraday trade

Aurobindo Pharma Q1FY25 results: Net profit jumps 61% to Rs 919 cr

Aurobindo Pharma on Saturday said its consolidated net profit increased 61 per cent year on year to Rs 919 crore in the first quarter ended June 2024, aided by strong sales across markets. The Hyderabad-based drug maker had reported a net profit of Rs 571 crore in the April-June quarter of last fiscal. Revenue from operations increased to Rs 7,567 crore in the June quarter as against Rs 6,851 crore in the year-ago period, the drug maker said in a statement. "We are pleased with our continued strong performance this quarter, with a significant top-line growth across all our business segments," Aurobindo Pharma Vice-Chairman and Managing Director K Nithyananda Reddy stated. The profitability was sustained by improved gross margins and operational efficiencies, while ramping up our recently commercialised plants, he added. "We are confident in our ability to achieve our growth targets for FY25," Reddy said.

USFDA scrutiny delays generic drug approvals for major Indian pharma firms

Big Pharma companies Cipla, Sun Pharma, Aurobindo Pharma, Dr Reddy's, and Lupin face intense scrutiny from the US Food and Drug Administration (USFDA)

Aurobindo Pharma board approves share buyback plan worth Rs 750 cr

Aurobindo Pharma on Thursday said its board has approved a share buyback plan of up to Rs 750 crore. The company's board has approved the buyback of up to 51,36,986 shares representing up to 0.88 per cent of the total paid-up equity share capital, Aurobindo Pharma said in a regulatory filing. The company will buy the shares at Rs 1,460 apiece for an aggregate amount of up to Rs 750 crore, it added. The drug firm said July 30 has been fixed as the record date for the Rs 750-crore share buyback scheme through the tender offer route. At the end of June 30, the company promoters owned 51.8 per cent stake, while foreign institutional investors (FIIs) and mutual funds owned 16.73 per cent and 19.17 per cent respectively. Shares of Aurobindo Pharma were trading 2.83 per cent down at Rs 1,332.90 apiece on the BSE.

Aurobindo stock at new high, up 5% as board to consider buyback on July 18

In the past one year, the stock has zoomed 89 per cent, as compared to 21 per cent rally in the BSE Sensex.