The United States Food and Drug Administration (USFDA) had conducted a pre-approval inspection (PAI) of the new injectable facility of Eugia Steriles, situated at Parawada Mandal, Anakapalli District in Andhra Pradesh, from 28 March 2024 to 5 April 2024. The unit has now received the EIR and the inspection is closed. Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services. The pharma major reported 61.1% surge in consolidated net profit to Rs 919.22 crore on a 9.8% rise in revenue from operations to Rs 7,457.65 crore in Q1 FY25 over Q1 FY24. Shares of Aurobindo Pharma fell 0.62% to currently trade at Rs 1,542.40 on the BSE. Powered by Capital Market - Live

Aurobindo Pharma announced that the USFDA has issued the Establishment Inspection Report for the new injectable facility of Eugia Steriles (a 100% subsidiary of Eugia Pharma Specialities and a step-down subsidiary of the company), situated at Parawada Mandal, Anakapalli District, Andhra Pradesh. The inspection was conducted from 28 March 2024 to 05 April 2024. Powered by Capital Market - Live

The domestic equity benchmarks traded with minor gains in early afternoon trade. The Nifty scaled above the 25,050 mark after hitting the day's low of 24,981.30 in early trade. Pharma shares advanced for the two consecutive trading sessions. At 12:30 IST, the barometer index, the S&P BSE Sensex, rose 142.15 points or 0.17% to 82,063.52. The Nifty 50 index added 48.55 points or 0.19% to 25,089.70. In the broader market, the S&P BSE Mid-Cap index rose 0.25% and the S&P BSE Small-Cap index added 0.19%. The market breadth was positive. On the BSE, 2,064 shares rose and 1,724 shares fell. A total of 127 shares were unchanged. Derivatives: The NSE's India VIX, a gauge of the market's expectation of volatility over the near term, shed 1.12% to 13.21. The Nifty 26 September 2024 futures were trading at 25,118.65, at a premium of 28.95 points as compared with the spot at 25,089.70. The Nifty option chain for the 26 September 2024 expiry showed maximum Call OI of 57.9 lakh contracts at the 25,000 strike price. Maximum Put OI of 103.4 lakh contracts were seen at 25,000 strike price. Buzzing Index: The Nifty Pharma index rose 0.69% to 23,416.50. The index added 1.76% in the two consecutive trading sessions. Natco Pharma (up 3.77%), Biocon (up 1.36%), Torrent Pharmaceuticals (up 1.23%), Laurus Labs (up 1.18%) and Lupin (up 1.16%), Zydus Lifesciences (up 1%), Sun Pharmaceuticals Industries (up 0.96%), Aurobindo Pharma (up 0.58%), Alkem Laboratories (up 0.54%) and Divis Laboratories (up 0.52%) edged higher. On the other hand, Sanofi India (down 1.57%), Granules India (down 0.67%) and Gland Pharma (down 0.18%) edged lower. Aurobindo Pharma rose 0.58%. The pharma major announced that its stepdown subsidiary, Eugia Steriles received its first product approval from the United States Food and Drug Administration (USFDA) for Lidocaine Hydrochloride injection. Stocks in Spotlight : Jubilant Pharmova rose 0.67%. The company's subsidiary, Jubilant HollisterStier LLC's (JHS) manufacturing facility located at Spokane, Washington (USA) received classification of 'Voluntary Action Indicated' from USFDA. The United States Food & Drug Administration (USFDA) conducted an audit of the facility from 28 May to 6 June 2024. The US drug regulator has now determined the inspection classification of the facility as 'Voluntary Action Indicated'. Ramco Systems added 2.41% after the company said it has launched 'Aviation Software 6.0' to drive transformation in M&E and MRO operations. Powered by Capital Market - Live

Lidocaine is a local anesthetic (numbing medication) that is used to numb an area of your body to help reduce pain or discomfort caused by invasive medical procedures such as surgery, needle punctures, or insertion of a catheter or breathing tube. 'The new injectable facility of Eugia Steriles (a 100% subsidiary of Eugia Pharma Specialities and a stepdown subsidiary of the company), situated at Parawada Mandal, Anakapalli district, Andhra Pradesh, which was inspected by the US FDA from 28 March 2024 to 5 April 2024, has now received its first product approval from the US FDA for Lidocaine Hydrochloride injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL),' Aurobindo Pharma stated. The sANDA was submitted as 'Prior Approval Supplement' for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility. Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services. The pharma major reported 61.05% jump in consolidated net profit to Rs 919.22 crore on a 9.82% rise in revenue from operations to Rs 7,457.65 crore in Q1 FY25 over Q1 FY24. Shares of Aurobindo Pharma added 0.43% to Rs 1,525on the BSE. Powered by Capital Market - Live

Aurobindo Pharma announced that the new injectable facility of Eugia Steriles (a 100% subsidiary of Eugia Pharma Specialities and a stepdown subsidiary of the Company), situated at Parawada Mandal, Anakapalli District, Andhra Pradesh, which was inspected by the US FDA from 28 March 2024 to 05 April 2024, has now received its first product approval from the US FDA for Lidocaine Hydrochloride Injection, USP, 1% (10 mg/mL) and 2% (20 mg/mL). The sANDA was submitted as 'Prior Approval Supplement' for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility.Powered by Capital Market - Live

Aurobindo Pharma Ltd is up for a fifth straight session in a row. The stock is quoting at Rs 1566.95, up 0.97% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.32% on the day, quoting at 25098.9. The Sensex is at 81934.07, up 0.27%. Aurobindo Pharma Ltd has risen around 11.53% in last one month. Meanwhile, Nifty Pharma index of which Aurobindo Pharma Ltd is a constituent, has risen around 5.51% in last one month and is currently quoting at 22729, up 0.62% on the day. The volume in the stock stood at 3.39 lakh shares today, compared to the daily average of 16.94 lakh shares in last one month. The benchmark August futures contract for the stock is quoting at Rs 1566, up 0.95% on the day. Aurobindo Pharma Ltd is up 89.06% in last one year as compared to a 29.76% spurt in NIFTY and a 51.24% spurt in the Nifty Pharma index.The PE of the stock is 47.56 based on TTM earnings ending June 24.Powered by Capital Market - Live

In May 2024, the United States Food and Drug Administration (US FDA) had conducted an inspection at Unit-III, a formulation manufacturing facility, of Eugia Pharma Specialities, a wholly owned subsidiary of the company, situated at Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana, from 22 January to 2 February 2024. Subsequently, the US FDA has determined the inspection classification status of this facility as 'official action indicated (OAI)'. In a regulatory filing made during market hours today, Aurobindo Pharma stated that subsequent to OAI, the aforementioned unit has now received a warning letter. There is no impact on the existing supplies to the US markets,' Aurobindo Pharma said in a statement. The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis. Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services. The pharma major reported 61.05% jump in consolidated net profit to Rs 919.22 crore on a 9.82% rise in revenue from operations to Rs 7,457.65 crore in Q1 FY25 over Q1 FY24. Powered by Capital Market - Live

Aurobindo Pharma announced that the USFDA has issued a warning letter for Unit-III of Eugia Pharma Specialities, a subsidiary of the company. There is no impact on the existing supplies to the US market. The warning letter comes subsequent to receiving the Official Action Indicated (OAI) status from USFDA earlier in May 2024. Powered by Capital Market - Live

Net profit of Aurobindo Pharma rose 61.05% to Rs 919.22 crore in the quarter ended June 2024 as against Rs 570.75 crore during the previous quarter ended June 2023. Sales rose 9.82% to Rs 7457.65 crore in the quarter ended June 2024 as against Rs 6790.64 crore during the previous quarter ended June 2023. ParticularsQuarter EndedJun. 2024Jun. 2023% Var. Sales7457.656790.64 10 OPM %21.7016.91 - PBDT1728.071208.34 43 PBT1323.89881.78 50 NP919.22570.75 61 Powered by Capital Market - Live

The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vagifem, 10 mcg of Novo Nordisk Inc. The product will be launched in Q2 FY25. Estradiol Vaginal Inserts USP, 10 mcg is indicated for the treatment of atrophic vaginitis due to menopause. The approved product has an estimated market size of $268 million for the twelve months ending June 2024, according to IQVIA. The drug maker now has a total of 521 ANDA approvals (504 Final approvals and 17 tentative approvals) from USFDA. Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services. The pharma major reported 79.5% jump in consolidated net profit to Rs 908.75 crore on a 17.1% rise in revenue from operations to Rs 7,580.15 crore in Q4 FY24 over Q4 FY23. The scrip fell 1.49% to close at Rs 1,399.60 on Tuesday, 6 August 2024. Powered by Capital Market - Live