Business Standard

Intas Pharmaceuticals

USFDA issues warning letter to Intas Pharma for lapses at Sanand plant

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

USFDA issues warning letter to Intas Pharma for lapses at Sanand plant
Updated On : 06 Aug 2023 | 12:13 PM IST

CCI clears ADIA's minority stake buy in Intas Pharmaceuticals

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 .

CCI clears ADIA's minority stake buy in Intas Pharmaceuticals
Updated On : 10 Oct 2022 | 11:08 PM IST

Intas Pharmaceuticals to go for $4-billion deals in a month

Teva's units in Europe and Mallinckrodt's US generic business among the planned bids

Intas Pharmaceuticals to go for $4-billion deals in a month
Updated On : 15 Sep 2017 | 12:38 AM IST

Meet Intas' Chudgars who silently made to the top

The company is the largest privately held pharmaceutical company in India with an annual turnover of $1 billion

Meet Intas' Chudgars who silently made to the top
Updated On : 06 Oct 2016 | 12:02 PM IST

Intas buys Teva assets for Rs 5,100 cr

Ahmedabad-based firm beats domestic rival Aurobindo, global giants Mylan and Novartis

Intas buys Teva assets for Rs 5,100 cr
Updated On : 06 Oct 2016 | 1:05 AM IST

Intas enters big league with $1-bn bid for Teva assets

The presence of PEs on the company's board has ensured our strategies are validated: Binish Hasmukh Chudgar

Intas enters big league with $1-bn bid for Teva assets
Updated On : 22 Sep 2016 | 2:01 AM IST

Intas plans to go for FDA nod for its newly acquired Ankleshwar API unit

The Gujarat based company acquired the biotech unit from RPG Life Sciences

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Updated On : 27 May 2016 | 2:28 PM IST