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USFDA INSPECTION

Cipla announces closure of USFDA inspection at Patalganga facility

Cipla recently announced the closure of inspection by United States Food and Drug Administration (USFDA) at the Patalganga manufacturing facility in Maharashtra. Shares of Cipla were trading 0.40 per cent lower at Rs 478.35 apiece on the BSE in the morning trade.

Biocon Bengaluru unit pre-approval inspection by USFDA concludes with zero observations

Biocon on Monday said that pre-approval inspection of...

USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility

As per the USFDA, a Form 483 is issued to Biocon's management at the...

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  • USFDA issued a form 483 with two observations, the drug firm said in a filing to BSE.

    Indian drug makers in the last few years have diversified their portfolio towards complex generics in an attempt to insulate themselves from pricing pressure in the US. The complex generic pipeline of Indian generic makers stands at 25%, it is this pipeline that is expected to pump up the sales numbers for Indian companies.

    The inspection of company's Vizag API manufacturing facility by the United States Food and Drug Administration (USFDA) has been completed, Lupin said in a filing to BSE. The inspection was carried out between January 13, 2020 and January 17, 2020, it added. The inspection for the API facility at Vizag closed with five 483 observations, Lupin said.

    According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. The company, however, said that it does not believe this inspection classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.

    "The inspection closed with two 483 observations," Lupin said.

    Alembic Pharma manufactures and markets generic pharmaceutical products across the globe.

    SMS Pharma today informed exchanges that the United States Food and Drug Administration (USFDA) conducted a cGMP inspection at Kandivalasa, Vipanagaram, Andhra Pradesh API manufacturing facility from January 13-17.

    The facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs, the company said. Strides has a portfolio of approved SGCs in the US and other regulated markets.

    The warning letter issued by USFDA to large pharma companies more than doubled in the first 10 months of 2019 compared with the previous year, CRISIL said, adding that close to 180 generic drug launches will be pushed out from their intended launch dates due to it.

    The sale of the gynac business comes two years after it sold its orthopedic business to the same company. Integrace will pay Rs 115 crore for four products of the portfolio that includes products like Dubagest, Mumfer and Fenza. These three products currently have sales of Rs 60 crore and are growing by 15%.

    "The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales," the drug firm said. Citing IQVIA, the company said Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of USD 469 million for 12 months ending September 2019.

    The tablets are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the United States Food and Drug Administration (USFDA), as per the company's announcement posted on the website of the US health regulator.

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