Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
After spending considerable time and energy in remediation efforts in the wake of the US Food and Drug Administration's warning letter on compliance issues, the company's leadership has finally set out to bring the house in order.
The latest price revision includes mostly cardiovascular drugs, anti-bacterials, anti-herpes, contraceptives and gastrointestinal medicines
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
The Delhi High Court on Friday stayed the ban on some fixed dose combination (FDC) drugs of Glaxo SmithKline, Wockhardt and Laboratories Griffon but said action against their sale could be taken in the absence of valid sale and marketing licence.
'Sharapova has been a US resident since early in her career, which does bring in a question of how or why she is using a drug that is not licensed there'
The World Health Organisation's technical advisory group will meet on October 26 to consider the Emergency Use Listing (EUL) of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech protecting against COVID-19, the global health agency's chief scientist said.
Competition in the US pharmaceutical market swelled in recent years, with increasing generic penetration.
The productivity of the Budget session was abysmal. The Lok Sabha functioned for 33% of its scheduled time (46 hours); the Rajya Sabha 24% (32 hours).
Ranbaxy Laboratories, India's biggest drugmaker, may lose as much as $140 million of revenue in 2009 after the US drug regulator blocked sale of more than 30 generic medicines and 7 APIs made in two factories of the company, according to analysts.
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
Serum Institute of India, the world's largest vaccine manufacturer, has a licence to produce the shot and has already manufactured close to 50 million doses.
Regulator's nod assumed more importance after the Maggi issue.
Substandard and fake drugs are rampant in India because of the highly fragmented industry.
The price regulatory pharma body has set limits to the extent pharma companies can increase the price of medicines in a year.
The high court had given the company six weeks for retesting.
Hetero has priced the injectable drug at Rs 5,400 per 100 mg vial. With More drugmakers in line to launch the drug soon, the prices may see a further erosion.
If any foreign account holder violates Indian laws, tax authorities can enforce repatriation of funds.
The multinational has filed infringement proceedings and is seeking an injunction against the Indian rival at the Delhi High Court, trying to block the Bangalore-based biotechnology firm from launching a generic version of Galvus, also known as vildagliptin.
Drug major Novartis has been slapped with a Rs 300-crore penalty by drug regulator NPPA for overcharging consumers on sale of Voveran, its best-selling painkiller medicine.
Swiss drug maker Novartis might face tough action from the country's drug regulator for allegedly giving fake documents while seeking renewal of registration for Tiamulin Hydrogen Fumerate (80 per cent granules), sources said.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
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The Drug (Prices Control) Order implemented in May last year brought into its purview 652 packs of 348 formulations.
In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.
The further distribution of vaccine to the districts will be done as per the registered beneficiaries, for which a separate communication will be done shortly, the letter stated.
TCS was the top gainer in the Sensex pack, rising around 2 per cent, followed by ONGC, SBI, L&T, Infosys, HCL Tech, ICICI Bank and Axis Bank. The broader NSE Nifty surged hit a record high of 14,109.40.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
The sources said that an ATC posted at the Indira Gandhi International Airport in New Delhi was subjected to the drug test.
The USTR has placed India on its "priority watch" list for two years in a row, saying the country's patent laws unfairly favour local drug makers.
The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.
In a statement, the state government alleged 'malicious attempts' to discourage the use of products lacking a halal certificate not only seek 'unfair financial benefits' but also form part of a 'pre-planned strategy to sow class hatred, create divisions in society, and weaken the country' by "anti-national elements".
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
In a statement on Tuesday, the European Commission said it had requested 'information from certain pharma companies asking them to submit copies of their patent settlement pacts.'
Prime Minister Narendra Modi on Friday received Bhutan's highest civilian award, the 'Order of the Druk Gyalpo', making him the first foreign Head of the Government to receive the honour.
