The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including failure of its quality control unit to ensure CGMP compliance, at its Sanand-based manufacturing plant. In a warning letter dated July 28, 2023, the US Food and Drug Administration (USFDA) pointed out various manufacturing lapses at the plant. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the USFDA said. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.." The USFDA inspected the manufacturing facility from November 22 to December 2, 2022. A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The USFDA said the company "failed to exercise its responsibility to ensure drug products manufactured are
Anti-trust regulator Competition Commission of India (CCI) on Monday cleared Platinum Owl's acquisition of a minority stake in Intas Pharmaceuticals. The proposed transaction involves a secondary acquisition by Platinum Owl of 3 per cent of the equity shareholding of Intas (on an outstanding shares basis). Platinum Owl is acting in its capacity as a trustee for Platinum Jasmine A 2018 Trust and Abu Dhabi Investment Authority (ADIA) is the sole beneficiary and settlor of the Platinum Jasmine A 2018 Trust. Intas is engaged in the business of development, manufacture and marketing of pharmaceutical formulations. In a separate combination, CCI approved acquisition of 100 per cent of the equity and compulsorily convertible debentures of five special purpose vehicles (SPVs) by IndInfravit and allotment of units of IndInfravit to CPHI-4 for the purpose of part-funding the acquisition of SPVs. The five SPVs are engaged in the operation and maintenance of highways in the states of Andhra .
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The company is the largest privately held pharmaceutical company in India with an annual turnover of $1 billion
Ahmedabad-based firm beats domestic rival Aurobindo, global giants Mylan and Novartis
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The Gujarat based company acquired the biotech unit from RPG Life Sciences