USFDA INSPECTION
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
Zydus Biologics’ Ahmedabad injectable facility gets 7 observations in USFDA inspection
Zydus Lifesciences has made headlines as its Zydus Biologics injectable plant in Ahmedabad underwent a USFDA inspection between April 27 and May 5, 2026. The inspection yielded seven observations, but significantly, there were no issues regarding data integrity. Zydus Lifesciences is already in discussions with the USFDA to ensure these observations are addressed in a timely manner.
Natco Pharma, 3 other pharma stocks decline up to 2.5% after important inspections at their units. Do you own?
Indian pharmaceutical stocks, including Lupin, Shilpa Medicare, and Natco Pharma, are under scrutiny following recent USFDA inspections at their manufacturing sites. These audits yielded regulatory observations, prompting companies to address the findings. Alkem Laboratories, however, reported no critical issues from a separate Armenian health ministry audit at its Sikkim facility.
Sun Pharma gets eight observations from USFDA for Halol plant
Sun Pharma announced that the USFDA issued a Form 483 with eight observations after inspecting its Halol manufacturing plant in Gujarat. The USFDA conducted a Good Manufacturing Practices (GMP) inspection at the facility from June 2-13, 2025. The Form 483, issued at the inspection's conclusion, highlights conditions that may violate the Food, Drug, and Cosmetic Act and related regulations.
India pharma units fare better in US checks in 2023
The drug regulator United States Food and Drug Administration (USFDA) has classified 13%, or 19 out of 145 inspections it carried out against Indian facilities, as Official Action Indication (OAI) in 2023, which is lower than the global average of 15% OAIs, according to a report by Indian Pharmaceutical Alliance and McKinsey & Company said.
Zydus Lifesciences gets 6 observations from USFDA for API plant
The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing.
Dr Reddy's clears USFDA inspection for two plants
Dr Reddy's said it has received establishment inspection report (EIR) for its formulations manufacturing unit in Srikakulam (FTO SEZ PU2), Andhra Pradesh. EIR means closure of inspection. The inspection was conducted from June 12, 2023 to June 16, 2023.
Lupin gets 2 observations from USFDA for Nagpur facility
"The inspection closed with two 483 observations," Lupin said.
Cipla announces closure of USFDA inspection at Bengaluru facility
The company had earlier said that USFDA issued seven observations after conducting a routine 'CGMP inspection' at Cipla's API manufacturing facility in Virgonangar, Bengaluru.
USFDA conducts inspection of Sun Pharma’s Halol site: Sources
The USFDA inspection at Halol in 2015 had resulted in 23 observations – a set of deficiencies in the manufacturing processes.
FDC sinks 8% as USFDA tightens screws
The stock fell 7.74 per cent to hit a low of Rs 232.30 on the BSE today morning.
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.
Strides Shasun R&D unit gets USFDA inspection closure report
USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
Dishman Pharma gets EIRs for 3 sites from USFDA
"Company's wholly owned subsidiary Carbogen Amcis AG, Switzerland has successfully completed United States Food and Drug Administration (USFDA) inspection for its two sites."
Sharon receives EIR report from USFDA on inspection closure
Sharon Bio-Medicine said it has received the establishment inspection report (EIR) from the USFDA on closure of inspection of its Dehradun manufacturing plant.
USFDA inspects Sharon Bio-Medicine's Dehradun-based plant
Last month, USFDA had issued a warning letter to the firm for failing to pay generic drug user fee by its owner for three years starting 2013.
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