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Stay updated on the latest stock market movements! Bharat Electronics secures a ₹2,463 crore defense contract, NTPC Green commissions the final phase of its Shajapur Solar Project, and Jubilant Pharmova gets a key USFDA update. Plus, major developments from Satin Creditcare, BEML, and Zydus Lifesciences. Watch now for all the key highlights!
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IPA also refuted the study's reliance on the FDA Adverse Event Reporting System (FAERS) data, stating that FAERS data is observational and does not prove causation between drugs and adverse events.
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Let's catch up on the latest stock market updates! IndusInd Bank has identified discrepancies in its derivative portfolio following an internal review. Hindustan Zinc has approved the issuance of ₹500 crore in non-convertible debentures. Ashoka Buildcon has secured a ₹311.92 crore turnkey project in Maharashtra, while MSTC has been awarded a two-year contract by Coal India for e-auction services. Indoco Remedies’ Hyderabad-based research unit recently underwent a USFDA inspection. NLC India’s board has given in-principle approval for a $200 million external commercial borrowing in Japanese Yen. Meanwhile, Bharat Electronics has secured fresh defence orders worth ₹843 crore, bringing its total order book for FY25 to ₹14,567 crore. Stay tuned for a detailed breakdown of these stock market movers!
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Join us for the latest stock market update where we cover the key stocks making headlines today. HFCL leads with a groundbreaking agreement under BharatNet Phase-III, while Waaree Energies secures a major solar module supply order. Plus, insights on IREDA and Tata Technologies' new trading contracts, Cyient's executive appointment, Patanjali Foods' legal victory, and Orchid Pharma's recent FDA inspection. Stay informed with our comprehensive overview of today's trading focuses!
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The first order impact will be a slow market share gain from innovators after a generic launch
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While ongoing manufacturing is not impacted, the USFDA's action the may affect the process of review of pending submissions from the facility for approval of new products, till the time the OAI status is not resolved.
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The pharma company said it intends to work with the US drug regulator and is confident of securing compliance for the facility soon.
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The management is primarily focusing on Indian assets which can bring synergy, followed by US assets. Cipla’s continued investment in US subsidiary InvaGen would de-risk the business model from a compliance point of view.
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A Republican win could be negative for EMs, while a Democrat victory is likely to be beneficial for countries like India
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Last week, brokerage firm UBS Securities also initiated a 'sell' call on Aurobindo Pharma, assigning it a price target of Rs 1,333, predicting a 12 percent downside.
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Paliperidone extended-release tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg have an estimated market size of $48 million for 12 months ended June 2024.
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In July, Suven Pharma had received a Form 483 from USFDA, with two observations regarding Casper Pharma, which the company said were procedural in nature, assuring these would be addressed in stimulated time.
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The company has received approval from the US Food and Drug Administration (USFDA) to market Amantadine extended-release capsules (68.5 mg) and tentative approval for Gocovri (137 mg) capsules
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Out of the 16 Abbreviated New Drug Applications (ANDAs) pending for the US markets, 11 are associated with this facility. To date, 36 ANDAs from this location have been approved.
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The US health regulator said it inspected the Patancheru (Mandal), Sangareddy, Hyderabad-based plant from January 22 to February 2, 2024.
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Despite the regulatory hiccups, the management of Aurobindo Pharma remains confident of its arm, Eugia Pharma recording sales of $600 million in FY25.
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The approval by the US Food and Drug Administration (USFDA) is for LEQSELVI (deuruxolitinib) 8 mg tablets, Sun Pharma said in a regulatory filing.
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The company has received final approval for its new drug application (NDA) from the US Food and Drug Administration (USFDA) to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets, the drug firm said in a statement.
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The OAI classification happened after the US FDA issued 10 observations for Zydus Life's Jarod facility back in April. It seems that those observations were likely not rectified by the drugmaker, leading to the OAI classification.
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The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) Selexipag for injection of strength 1,800 mcg/vial, Alembic Pharmaceuticals said in a statement.
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The US Food and Drug Administration alerted brand-name and generic companies June 18 about a research company in India that had falsified the data used in key studies to gain approval of their medications.
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The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Bromfenac Ophthalmic Solution, 0.07 per cent, Alembic Pharmaceuticals said in a regulatory filing.
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According to the report, Dr Reddy's Laboratories is recalling drugs to treat insomnia and gout in the American market.
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Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosutinib Tablets.
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The US drug regulator inspected Aurobindo Pharma arm Eugia Pharma's Telangana facility from February 19-29, 2024.
