Sun Pharma gets 10 observations from U.S. FDA for Halol plant
The Hindu
New Delhi
Sun Pharma on Tuesday said the U.S. health regulator has issued a 'Form 483' with ten observations after inspecting its Halol-based manufacturing plant in Gujarat.
As per U.S. FDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The U.S. Food and Drug Administration conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, the Mumbai-based drug maker said in a regulatory filing.
"At the conclusion of the inspection, U.S. FDA issued a Form-483, with 10 observations. The company is preparing the response to the observations, which will be submitted to the U.S. FDA within 15 business days," it added.
The company is committed to addressing the observations promptly, Sun Pharma noted.
It remains committed to working closely with U.S. FDA and continues to enhance its GMP compliance on an ongoing basis, it added.
Adani Group plans a ₹1.5 lakh crore investment in Kutch, focusing on renewable energy, ports, and logistics over five years.
Mukesh Ambani announces ₹7 lakh crore investment in Gujarat, emphasizing clean energy, AI, and support for Olympic ambitions.
India mandates selfies and 'penny drop' for crypto KYC, discouraging ICOs and ensuring strict anti-money laundering measures.
Mukesh Ambani announces ₹7 lakh crore investment in Gujarat, emphasizing clean energy, AI, and support for Olympic ambitions.
The All India Cashew Association calls for urgent action against illegal cashew imports threatening India's domestic processing industry.
Moody’s upgrades Shriram Finance’s outlook to positive, citing strategic benefits from MUFG Bank's upcoming investment and improved financial stability.
India's rice exports soar to near record levels in 2025, driven by lifted curbs and increased global demand.
Dr. Reddy's responds to U.S. FDA queries regarding its Hyderabad biologics facility following a recent inspection.
Techno Paints plans a ₹500 crore IPO in FY27, featuring Sachin Tendulkar as brand ambassador to boost growth.
India's shift from Russian oil imports will have limited fiscal impact due to low global prices and reduced discounts.
The latest Household Consumption Expenditure Survey (HCES) by MoS&PI reveals a transformative shift in India’s economic landscape. For the first time in over a decade, granular data on Monthly Per Capita Expenditure (MPCE) highlights a significant decline in the proportional share of food spending—a classic validation of Engel’s Law as real incomes rise. Between 1999 and 2024, both rural and urban consumption pivoted away from staple-heavy diets toward protein-rich foods, health, education, and conveyance. As Indian households move beyond subsistence, these shifting Indian household spending patterns offer vital insights for social sector policy, poverty estimation, and the lived realities of an expanding middle-income population.
Investors shifted to Gold ETFs in December 2025, with record inflows amid macro uncertainty and declining equity returns.
Aurobindo Pharma's subsidiary receives Health Canada NOC for Dyrupeg, confirming its pegylated filgrastim biosimilar's safety and efficacy.