USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
Maggi has also come on the radar of US Food and Drug Administration.
The only category of pharmaceuticals that showed a negative growth in exports this time was herbal products, exports of which stood at $299 million as compared to $ 312 million in the previous year.
All of Ranbaxy's India-based factories are currently banned by the FDA from exporting medicines to the United States, the company's largest market, after the regulator's inspection found violation of its so-called good manufacturing practices.
The Oxford/AstraZeneca vaccine is also being produced as part of a tie-up by the Serum Institute of India.
India lost its competitive advantage as China gave fiscal benefits to its local manufacturers. Besides, recent policy flip-flops have, however, dented India's image as the 'pharmacy of the world'.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.
The FDA issued the letter on October 15, and has given the company 15 days to respond.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
In March, he had said that China is responsible for the spread of the novel coronavirus and called the COVID-19 as the "Chinese Virus".
Rosier year-end seen for Indian pharma thanks to faster US approvals.
The US Food and Drug Administration said on Sunday that over 70,000 patients in the country had been treated with convalescent plasma, which is made using the blood of people who have recovered from coronavirus infections.
Cambridge, Massachusetts-based Moderna's announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.
A key lesson for the pharmaceutical sector in this case is to not downplay the significant impact that regulatory non-compliance can have on operations.
As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.
The company has launched only 3 new products during 2015 when compared to 14 launches in 2014
The FDA actions eventually led to a $500-million fine for Ranbaxy as well as the effective mothballing of many of its Indian factories.
It is one of 42 drug-making factories in India that the FDA has banned in recent years
Pharma major Ranbaxy Laboratories has set aside Rs 257.4 crore (Rs 2.57 billion) towards the financial impact of a US ban on import of products made at its plant at Toansa.
Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.
An end to Sun Pharma founder Dilip Shanghvi's woes are not in sight.
Pfizer and BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy endpoints.
While the US health regulator did not specify details for issuing the alert, it said 'detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices'.
Credit Suisse analysts cut their rating on Sun Pharma stock to 'neutral' from 'outperform
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
Sayre Therapeutics aims for a spot among top 5 players in oncology.
Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India.
India on Tuesday temporarily licensed the export of paracetamol and anti-malarial drug Hydroxychloroquine in appropriate quantities to some countries, which have been particularly badly affected by the coronavirus pandemic.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
The BSE Midcap also cut all its intraday gains to shed 0.3% at close
Researchers claim to have developed a new treatment for ovarian cancer that can increase the rate of tumour shrinkage and prolong the time until cancers recur.
Vice President Mike Pence said Trump had authorised a ban on entry of foreign nationals who travelled to Iran in the last 14 days. The United States also advised its citizens not to travel to parts of South Korea and Italy, from where reports of coronavirus have appeared.
GE Healthcare has already filed five global patents for its design.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
Sun Pharma and Dr Reddy's top list in terms of those who face most class-action litigation
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
Over 3,66,000 Americans have tested positive for the deadly coronavirus.
Indian companies have made acquisitions of $1 billion so far in January
© 2026 Rediff.com - Advertise with us - Disclaimer - Privacy Policy - Sitemap - Feedback - About us - Terms of use - Grievances