Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat. "The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021. This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company's management of objectionable conditions. Alembic Pharma said none of the observations were related to data integrity and were procedural in nature. "The company is preparing the response to the observations, which will be
Healthcare companies to post decent growth in revenues in Q3FY21
A financial analyst recently told that Pfizer's involvement in the coronavirus pandemic was about "as much public relations as it is a financial return
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the USFDA
The incentive will be in the range of 5-10 per cent of production value, sources said.
Till Nifty Pharma holds above the 11,180 mark, the bullish bias will prevail, charts suggest.
In the past month, the S&P BSE Healthcare index underperformed the market by falling 5 per cent, as compared to 5.4 per cent rise in the S&P BSE Sensex
Firm prunes net debt by 40% since March 2020; consolidated income up 13%
The pharmaceutical sector is the top performer in India's $2.1 trillion equity market this year after the coronavirus pandemic turned global investors' spotlight on health-care companies
Glenmark Pharma announced the launch of its generic version of Nintedanib (NINDANIB), used for the treatment of pulmonary fibrosis, in India
Driven by industries like pharma, fast-moving consumer goods, education and IT, hiring activity in India saw a growth of 24% in September compared to the previous month
In its judgment the court said India can not be dependent on China for APIs and ordered the formation of a five member committee to ensure self-reliance
A Delhi court on Monday declared four directors of a Gujarat-based pharma firm,Sterling Biotech Ltd (SBL), fugitive economic offenders in a Rs 8,100-crore bank fraud case
Drug firm Hetero on Friday said it has launched a pack of its generic oral antiviral drug-- Favivir 800/200-- for the treatment of mild-to-moderate symptomatic COVID-19 patients in India.
Living up to its moniker of a defensive bet, the Rs 2.8 trn Indian pharmaceutical sector is set to emerge more or less unscathed from the Covid-19 pandemic this fiscal, CRISIL said on Thursday.
In the probe, the directorate will determine the existence, degree and effect of any alleged dumping in respect of the product from China
Pharmaceutical companies are committed to a science first approach in the development of COVID-19 vaccines even as the pressure piles on to end the pandemic
Zydus Cadila said it has received approval from USFDA to market potassium chloride extended release tablets, a mineral supplement used to treat or prevent low amounts of potassium in the blood
The next upside for Nifty Pharma is located above the resistance of 12,100 levels.
Gilead Sciences Inc will acquire biopharmaceutical company Immunomedics Inc for $21 billion, a move that will strengthen its cancer portfolio by gaining access to a promising drug