PROHIBITION OF DRUGS
18% of Indian pharma launches to be delayed in US, says Crisil
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.
Pain for big Indian pharma companies continue warns CRISIL, as FDA woes remains unresolved
Indian drug makers in the last few years have dive...
USFDA in active mode, issues obersvations to 4 drug makers in 3 days!
SMS Pharma today informed exchanges that the United States Food and Dru...
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.
USFDA inspects Alembic Pharma's facility in Karkhadi, Gujarat
USFDA issued a form 483 with two observations, the drug firm said in a filing to BSE.
Strides arm receives EIR for its US facility
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.
Biocon Bengaluru unit pre-approval inspection by USFDA concludes with zero observations
Biocon on Monday said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations.
Illegal medicinal drug ring busted in Punjab, Delhi and UP, 7 lakh tablets seized
The NCB has unearthed an inter-state nexus of psychotropic medicine traffickers with the seizure of over 7 lakh tablets and more than 1,400 ...
Strides gets USFDA nod for anti-allergic drug
The company said, it is focusing on building a private label business in the US by leveraging its portfolio of products across softgels, tablets, capsules and other proprietary formats.
Prohibit use of e-cigarettes on campus, sensitise students of ill effects: UGC tells varsities
"All universities and higher educational institutions are requested to prohibit the use of electronic cigarettes in their campus and make students aware of bad effects of e-cigarettes and the harm that nicotine in any form can do to their growing brain," the UGC said in a letter to Vice Chancellors and heads of institutions.
IIT Roorkee researchers find antibiotic against multi-drug resistant bacteria
In a new study published in the journal, ‘Journal of Antimicrobial Chemotherapy’, IIT Roorkee researchers screened a library of 11,000 compounds against the Gram negative bacteria, Escherichia coli and discovered 30 novel potent antibacterials.
Lupin gets 5 observations from USFDA for its Vizag facility
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.
Wockhardt rallies after revival plan gets a boost from drug nod
Investors cheered the news, sending Wockhardt’s shares up by 5.7 per cent on the BSE on Thursday.
Pharma cos may face Rs 10-lakh penalty, 2-year jail term for deceptive drug ads
Pharmaceutical companies or anybody involved in exaggerating how well their drugs work will face exemplary penalty and imprisonment, according to the proposed amendments to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
Sebi levies Rs 1.83 cr fine on 29 entities for fraudulent trading in Dhanleela
The regulator has imposed fine in the range of Rs 5 to Rs 15 lakh each on the individuals for violating provisions of Prohibition of Fraudulent and Unfair Trade Practices.
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