The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
Several companies, including Indian units of Abbott Laboratories and Pfizer Inc, and domestic firms like Cipla Ltd and Macleods Pharmaceuticals, went to the Delhi High Court to try to get the ban lifted.
Food and Drug Authority Ghana said in a statement that officials of Bliss GVS Pharma of India and Ghanaian drug maker Tobinco Pharmaceuticals have apologised to it for importing 'fake malaria medicine' to Ghana to treat malaria in children.
Weak scientific capabilities, lack of desire to advance knowledge, and regulatory uncertainty are some of the hurdles Indian drug companies face, says Chirantan Chatterjee.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
Roadblocks ahead as these medicines could face new clinical tests, more scrutiny
While the opposition party asked the government to stop boasting about India being a pharmacy to the world and take strictest action, the ruling party accused it of deriding India in its "hate" for Prime Minister Narendra Modi.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
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The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.
Dr Reddy's on Monday said it would acquire Switzerland-based Roche's bulk drug business in Mexico for $59 million.
To keep price control to a minimum, the government can act in two areas where it has not done so far.
A bench comprising Chief Justice Ranjan Gogoi and Justice Deepak Gupta held the former Ranbaxy promoters guilty of contempt of court and said that they had violated its earlier order by which the sale of their controlling stakes in Fortis Group to Malayasian firm IHH Healthcare was put on hold.
The world's second-largest drug maker, GlaxoSmithKline (GSK), is making India a major manufacturing hub for its free global drug supply to treat neglected diseases.
In a victory for Indian drug companies, patent protection has been refused to Tenofovir, an anti-AIDS medicine of the US-based Gilead Sciences. The decision was taken by the patent office in New Delhi.
Povidone iodine ointment and solutions are available in the market under various popular brands such as Betadine and Wokadine.
The Mumbai-based firm said it has signed an pact with the Department of Health, Government of Brazil and Farmanguinhos, the largest public sector undertaking in health care in Brazil, to supply the drug.
Hyderabad is likely to lose its status as the pharmaceutical capital of the country if the current political turmoil in Andhra Pradesh continues and the state is bifurcated, according to the head of the Bulk Drug Manufacturers Association (BDMA).
Two employees of a drug manufacturing company in Indore were killed and six others became ill after inhaling poisonous gas leaked from the production unit. The incident took place at Rinilife Science Private Ltd in the city's industrial area on Sanver Road late on Saturday night, the police said, adding that the gas leaked in the production unit of the company. The deceased were identified as Subhash Pal, 28, and Dinesh Borana, 30, the police said today.
The letter was the latest sign of US frustration about the business environment in India.
The government on Wednesday said Indian drug makers Ranbaxy and Cipla have approached it for assistance in manufacturing Tamiflu to fight bird flu
The Union Minister for Chemicals, Fertilisers and Steel Ram Vilas Paswan on Monday said from April 1 onwards, the prices of drugs would include local taxes.
Though there is no official word, the sources said the government is not ready to give in to the indemnity demands of the US drug manufacturers against liabilities in case of adverse effects.
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million. Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
Sources say FDA letter over product and not entire facility
Pulse oximeters, hand sanitisers, temperature check equipment and ambulances too will attract lower 5 per cent tax.
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.
In a move to focus on its core FMCG strength, the Burman family, promoters of Dabur India, last week announced their exit from the pharma business.
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
A random check had found that tests failed to prove the medicines were same as the patented drugs.\n
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.
Several firms are stepping up to help their workforce cope with soaring temperatures
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
Former actress Mamta Kulkarni was on Saturday named as a prime accused in a multi-crore drug racket linked to drug baron Vicky Goswami, with Mumbai police claiming that she was actively involved in the illicit activities and would seek her extradition from Kenya.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
The South African government and large pharmaceutical companies are in combat mode regarding the proposed national policy on intellectual property that hopes to improve access to medicines for the poorer sections of the population.
The Supreme Court on Tuesday tore into Patanjali Ayurved's defence for putting out misleading advertisements, rejecting the apology from yoga guru Ramdev and the firm's managing director Acharya Balkrishna as 'lip service' and warned them against perjury.
K Anji Reddy from a small village near Vijaywada, quit his job with the government-owned Indian Drugs and Pharmaceuticals Limited in 1974 to set up his own company. The rest is history.
National security advisor Ajit Doval on Friday suggested that various central armed police forces of the country should have "jointness" and interoperability among themselves like the ongoing plan for the defence forces.
