USFDA
Cipla expects US business to draw support from upcoming product pipeline
Cipla reported a significant decline in its consolidated net profit for the second quarter of FY27. The company's North American revenue fell by 19% due to increased competition impacting sales of generic Revlimid. However, Cipla anticipates that its upcoming product pipeline will support performance in North America. In India, domestic revenue rose, providing some resilience amidst challenges in the US market.
Dr Reddy’s Q2 Results: Net profit falls 36% YoY to Rs 913 crore, revenue declines marginally
Dr Reddy’s Laboratories reported a 36% year-on-year profit decline to Rs 913.4 crore in Q2 FY27, while revenue slipped 1.5%. North America weakness pressured performance, offset partly by growth in India and emerging markets, alongside biosimilar approvals and strategic partnerships.
Cipla subsidiary clears USFDA inspection with zero observations
Cipla on Friday said a routine US Food and Drug Administration (USFDA) inspection at its wholly owned subsidiary InvaGen Pharmaceuticals' manufacturing facility in Hauppauge, Long Island, New York.
Pharma Q2 Outlook: Pricing pressure, US competition to weigh on select players
India's pharmaceutical companies are expected to have a mixed performance in the upcoming September quarter. Companies like Sun Pharmaceutical Industries and Aurobindo Pharma are likely to report good growth. In contrast, Dr Reddy's Laboratories and Lupin may face challenges due to increased competition and a high base. Pricing pressure and elevated raw material costs are also expected to impact overall performance.
Zydus moves closer to US market for Keytruda biosimilar as FDA accepts application
Zydus Lifesciences has received acceptance for its application regarding the biosimilar of Keytruda, which is a major cancer drug. The USFDA is expected to complete its review process by the third quarter of 2027. This biosimilar, named FYB206, was developed without a comparative Phase III efficacy trial. Zydus aims to make effective treatments more accessible in the oncology field in North America.
Dr Reddy’s Laboratories receives two observations for Andhra Pradesh facility
The US health regulator completed a Pre-Approval Inspection (PAI) at the company's FTO-11 manufacturing unit from October 5-7, Dr Reddy's Laboratories said in a regulatory filing on Thursday.
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CPHI Milan: Beyond generics, how Indian pharma is rewriting its global playbook
At CPHI Milan, Indian pharma players are looking beyond traditional exports, using partnerships, licensing, CDMO, and differentiated products to expand their global footprint as geopolitical and supply-chain risks reshape the industry.
Last line of defence! How 7 Nifty stocks survived the market’s two-month bloodbath
In an unprecedented downturn, the Nifty has faced its longest losing streak in 25 years, sliding for over eight weeks as foreign investors withdrew significant funds from Indian equities. Despite this market decline in September, seven stocks, led by Kotak Mahindra Bank and Dr Reddy's Laboratories, demonstrated resilience. Particularly, Kotak Mahindra Bank's performance is linked to robust analyst endorsements and optimism surrounding the banking sector's recovery.
Stocks in news: Tata Group, ITC, IRFC, NCC, Zydus Lifesciences and JSW Energy
The Indian equity markets faced a significant downturn, with benchmark indices slipping past vital support thresholds. The Nifty 50 saw a decline of 360.25 points, reflecting increased investor anxiety. Key players like Tata Group, ITC, and Indian Railway Finance Corporation draw attention following recent news. Analysts suggest that if the market falls further below these critical levels, the correction may continue.
Stocks in news: RVNL, Lenskart, Mazagon Dock, Maruti Suzuki India and Nestle India
Indian equities concluded Friday's session with marginal gains, supported by softer crude prices. Several companies like RVNL and Mazagon Dock are expected to be in focus on Monday. RVNL secured a significant order from East Coast Railway for railway line works. Mazagon Dock plans a substantial investment in a new shipyard project. Lenskart Solutions is anticipated to see a large block deal transaction.
Dr Reddy's inks pact with Gilead for once-yearly HIV prevention drug lenacapavir
Dr Reddy's Laboratories and Gilead Sciences have signed a licensing agreement. This pact involves investigational once-yearly lenacapavir for HIV prevention. The agreement facilitates manufacturing and supply planning for 120 countries. This collaboration builds upon a previous pact for twice-yearly lenacapavir.
Stocks in news: Infosys, Mazagon Dock, Fortis Healthcare, JSW Energy and Kalpataru Projects
On September 16, Indian markets experienced a careful resurgence, with the Nifty and Sensex both moving upwards. This rebound was fueled by increased investments in banking and prominent stocks following a steep drop the previous day. Key players like Infosys and Mazagon Dock are under scrutiny due to recent corporate events.
Alembic Pharma clears USFDA inspection at Vadodara bioequivalence facility with nil observations
Alembic Pharmaceuticals has reported that its Vadodara facility passed the recent inspection by the United States Food and Drug Administration with flying colors. Conducted from August 31 to September 10, 2026, the inspection resulted in zero observations, leading to a clean report from the USFDA and highlighting the facility's commitment to excellence.
How PGIM India's Rs 112 crore Healthcare Fund picks CDMO stocks to generate alpha
PGIM India Healthcare Fund generated a 22% return over the past year by over-allocating to high-growth segments like CDMO, specialty pharma, and hospitals. Anandha Padmanabhan shares insights on navigating hospital capacity expansions, China-plus-one opportunities, GLP-1 dynamics, and key stock-selection strategies across healthcare sub-sectors.
Gland Pharma block deal: Fosun Pharma divests 99 lakh shares worth Rs 2,800 crore
Fosun Pharma sold a 6% stake in Gland Pharma for ₹2,800 crore via a block deal, reducing its holding to 45.77%. Major buyers included Kotak, Axis, and ICICI Prudential Mutual Funds, while Gland Pharma shares closed higher at ₹2,932.40.
Lupin gets USFDA approval for Modafinil tablets to treat excessive sleepiness
Pharmaceutical major Lupin announced its USFDA approval for Modafinil tablets. These tablets are used to treat excessive sleepiness in adult patients. The approved drug is bioequivalent to Provigil Tablets of Nuvo Pharmaceuticals. Modafinil tablets had estimated annual sales of USD 70.7 million in the United States. Lupin currently operates 15 manufacturing facilities globally.
Large trade alert! Gland Pharma shares fall 3% after 1.2 crore shares change hands in 2 block deals; promoter Fosun likely seller
Gland Pharma shares fell 3% after 1.22 crore shares changed hands in two block deals worth nearly Rs 5,818 crore. Promoter Fosun Pharma Industrial was reportedly looking to sell a 5% stake for Rs 2,279.5 crore. Meanwhile, the company’s recent USFDA inspection of two Visakhapatnam facilities concluded with zero Form 483 observations.
Block deal alert! Gland Pharma shares fall 3% as 1.2 crore shares change hands in 2 block deals; promoter Fosun likely seller
Gland Pharma shares fell after a significant block deal involving Fosun Pharma Industrial. The company's VSEZ facility received zero USFDA observations after a recent inspection. Gland Pharma reported strong Q1FY27 results with increased profit and revenue. Its CDMO and B2B businesses showed substantial year-on-year growth. The pharma stock has gained significantly year-to-date.
Gland Pharma shares: Promoter Fosun Pharma likely to divest 5% equity worth Rs 2,279 crore via block deal
Fosun Pharma plans to divest 5% equity in Gland Pharma through a Rs 2,279.5 crore block deal at Rs 2,763 per share. Gland Pharma reported a 47% rise in Q1FY27 profit and operates globally, with strong R&D and growth.
Aurobindo Pharma gains over 3% as subsidiary launches generic Advair Diskus in US; stock up 41% YTD
Aurobindo Pharma shares rose sharply after its subsidiary Lannett Company launched the generic equivalent of Advair Diskus in the US. The inhalation product, available in two strengths, marks the first commercialised product from Aurobindo’s inhalation pipeline. The stock has gained 41.16% year-to-date in 2026.
USFDA ends inspection of Aurobindo Pharma arm's facility with 4 observations
Aurobindo Pharma announced its subsidiary Lannett Company LLC's facility inspection concluded. The US Food and Drug Administration conducted this routine inspection from August 17-21, 2026. Four procedural observations were noted during the Seymour, USA facility's review. The company will provide its response to the USFDA within the required timeframe.
Zydus Lifesciences gets USFDA nod for generic ascorbic acid injection
Zydus Lifesciences secured final USFDA approval for its generic ascorbic acid injection. This approval is for the treatment of scurvy in specific patient groups. The company's product is the generic equivalent of the Ascor injection. The USFDA designated this application as a Competitive Generic Therapy. Zydus will market the product in the United States market.
Strides Pharma Science shares jump 9% after USFDA EIR for Bengaluru facility
Strides Pharma Science shares rise sharply on Thursday after the USFDA issued an Establishment Inspection Report (EIR) for its Bengaluru facility, concluding a recent cGMP inspection. The inspection ended with five observations, which the company addressed through corrective actions. The regulatory closure offers relief after the stock’s recent weakness.
Lupin shares in focus after USFDA nod for drug to treat excessive daytime sleepiness
Lupin received USFDA approval for generic Pitolisant Tablets, strengthening its US portfolio and specialty generics presence. Shares remain technically weak despite strong long-term returns, with FIIs raising their stake while mutual fund holdings declined. The stock trades below most key moving averages, keeping near-term momentum subdued despite the positive regulatory development.
Lupin gets USFDA nod for generic tablets to treat excessive daytime sleepiness
Pharma major Lupin Ltd announced receiving final USFDA approval for its generic Pitolisant tablets. These tablets are indicated for treating excessive daytime sleepiness in patients. The US health regulator approved strengths of 4.45 mg and 17.8 mg. Lupin's Pitolisant tablets are bioequivalent to Wakix, a prescription medicine. This approval marks a significant step for the company in the US market.
Aurobindo Pharma arm Eugia Pharma's Telangana unit gets warning letter from USFDA
Aurobindo Pharma announced its subsidiary Eugia Pharma received a USFDA warning letter. This follows an inspection of their Telangana formulation manufacturing facility. The inspection concluded with four observations and an official action indicated status. The company stated existing US market supplies remain unaffected by this development. Aurobindo Pharma continues its commitment to ongoing compliance with the US FDA.
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, Aurobindo Pharma Ltd (APL) said in a regulatory filing.
USFDA made 9 observations post Halol unit inspection: Sun Pharma
The United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Pharma said in a BSE filing.
USFDA to hold workshops across India on quality requirements
USFDA plans to conduct workshops across India in the next one year in order to sanitise Indian drug cos about the changing quality requirements.
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