Daiichi-Sankyo's $5.3 billion acquisition of India's biggest drugmaker will help the Japanese company compete in the US markets with rivals such as Mylan and Israel-based Teva Pharmaceuticals and climb to become the world's 15th largest pharmaceutical company. Thus it is an important move on the part of an original drug research company to attach generic business portfolio," noted Ranjit Shahani, the vice-chairman and managing director of Novartis India.
'The world over, everybody is asking for the same medicines, same APIs, same KSMs.' 'However, there is just one supplier -- China -- for the entire world.'
Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India seeking emergency use authorisation for their COVID-19 vaccines.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
Indian government has extended price caps to 39 more medicines ranging from commonly used diabetes drugs to antibiotics.
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.
The transition of Class A and Class B medical device makers to the licensing regime by October 1 seems to be an uphill task with several small and medium manufacturers saying they are still awaiting the audit from the government authorities. If the licenses don't come through, either due to lack of audits or MSME units not clearing the audits, then a few thousand small-scale medical device units will face the issue of business continuity in three weeks. Class A medical devices are those with low to moderate risk to the patient or user (surgical dressings for example), while Class B medical devices refer to devices with moderate risks that require special controls (catheters for example).
The $66 million (Rs 272.8 crore) Leiner Health Products is likely to sue DRL for the early divorce (the agreement has lasted only four years) from the alliance.
The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has received nod for it's Hydrocortisone Butyrate Cream USP (0.1 per cent), abbreviated new drug approval from the United States Food and Drug Administration, Glenmark Pharmaceuticals said in a statement.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
Sun Pharmaceutical's acquisition of Ranbaxy has received final approvals.
The pharmaceutical companies may suffer sales loss of Rs 3,000 crore (Rs 30 billion) if the government's span of control increases, as proposed in the new pricing policy for the medicines, a section of the industry said on Monday.
Perched in the hills of Darjeeling, the factory was set up in 1874, but has remained shut since 2001. Efforts to reopen the colonial era establishment are now on a war footing.
The Rs 1,027-crore (Rs 10.27 billion) company has filed 13 abbreviated new drug applications and 22 drug master files with the US Food and Drug Administration and regulatory agencies in Europe for supply of formulations and active pharmaceutical ingredients. Some of the ANDAs challenge innovator patents and the company's strategy will be to partner with established companies in the US and Europe for marketing formulations, said Pranav Amin, director, Alembic.
The third-quarter financials didn't excite market watchers. But equity investors can still make money if they invest in the right stocks.
Netmed plans to procure from drug manufacturers and sell to pharmacies it has tie-ups with, and to spread its network to all tier-II and tier-III cities.
In a fresh round of patent battle over the launch of generic drugs in the US market, domestic pharmaceutical majors Orchid, Sun Pharma and Ranbaxy Laboratories have been sued by Cima Labs, Otsuka Pharmaceutical Co and Abbott Laboratories, respectivel
'The worst case scenario is a rebound of the virus.' 'Life is not going to be what it was.' 'Life as we know it has changed forever.' 'The new normal therefore is test, trace and treat.'
US President Donald Trump thanked PM Modi for lifting curbs on the export of hydroxychloroquine.
As cases of 'black fungus' among COVID-19 patients in the country rise to cross 7,000, the Centre on Thursday urged all states and union territories to declare it as a notifiable disease under the Epidemic Diseases Act to ensure mandatory surveillance to tackle the 'new challenge'.
Excise duty on drugs likely to be halved
Ranbaxy Laboratories has acquired a generic product portfolio accounting for eighteen products belonging to the Spanish pharmaceutical Company Efarmes, S. A. Unipersonal for sale in the Spanish market.
The Indian Medical Association on Monday expressed shock over the 'blatant lie of World Health Organisation certification' for Patanjali's Coronil tablet, which the company claims is an evidence-based medicine to fight COVID-19, and demanded an explanation from Union Health Minister Harsh Vardhan in whose presence the medicine was launched.
If the vaccine is recommended for use as a booster against Omicron, it may significantly boost the demand for Covishield in India.
'We expect to get the approval in the next few weeks,' says Deepak Sapra, CEO, API and pharmaceutical services, Dr Reddy's Laboratories (DRL).
Takeda had filed a case of patent infringement in response to Zydus' abbreviated new drug application.
A government committee is looking at going beyond mere economic considerations and recommend an essentiality-linked pricing structure, it is learnt.
Ajit Mishra, vice president, research, Religare Broking, answers your stockmarket queries.
The Bharatiya Janata Party in Maharashtra objected to the pharma executive's grilling by Mumbai police, saying the Shiv Sena-led government in the state was playing politics amid the pandemic.
This unprecedented rate could attract more global companies to enter the domestic drug market, thus triggering more buyouts of Indian companies by multinational drug makers, said industry experts.
India's exports during the first week of September jumped 13.35 per cent year-on-year to $ 6.12 billion, official data released on Thursday showed. At the same time, imports declined by 21.37 per cent to $ 6.85 billion. Consequently, the deficit during September 1 to 7 worked out to $ 730 million.
Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy
Medicine prices in India are set to go up by 1-2 per cent as the National Pharmaceutical Pricing Authority has decided to permit companies to factor in the rising packaging and processing costs into the retail price. The panel will notify the revised three costs -- for conversion, packaging and packing material -- shortly. The norms were finalised last week after a six-month-long analysis of the market.
'The government wants farmers to diversify from rice and wheat, and create another green revolution. Cannabis can play a big part in that'
Sun Pharmaceutical Industries and its subsidiary, Caraco Pharmaceutical Laboratories, have reached a settlement agreement with drugmaker Forest Laboratories and licensing partner H Lundbeck AS, over a pending patent infringement dispute over Forest's blockbuster antidepressant, Lexapro.
Biocon was scouting for more strategic alliances and exploring opportunities for outlicensing its biotech drugs under development, as it pitches for a slot among the top three bio-pharmaceutical players across the globe, said Kiran Mazumdar-Shaw, chairman and managing director.
