GlaxoSmithKline plans a radical shift in patent policy that seeks to encourage copies of its medicines in poor countries, widening access and possibly diminishing calls for compulsory licenses or other challenges based on price.
India's Lupin said in a Bombay Stock Exchange filing on Tuesday that it had received four observations for two plants at its Mandideep site following a two-week inspection by the FDA in February.
Japan has approved a new biosimilar of Sanofi's blockbuster Lantus (insulin glargine) as its creator Biocon chalks up a much-needed win after a tough 2015.
The World Health Organization (WHO) has suspended its approval of all tuberculosis drugs manufactured by Svizera Labs, saying the Indian drugmaker's production standards and quality management were unreliable.
BioPharmaSpec is expanding its business into the potentially lucrative Asian market as new business development teams begin work in India and the Asia-Pacific region this month.
India's domestic drug market could see an INR38 billion ($570.7 million) hit from a ban on more than 300 fixed-dose drugs that combine therapies often without new clinical trials in a widely used method that has formulations running into the thousands, many of which are approved at the state level.
Indian regulators over the weekend included some popular cough syrups containing codeine in a drug ban in what was deemed an effort to tighten up the nation's supply chain of opiates to fight smuggling and drug addiction. But the action by the Drug Controller General of India has unleashed a firestorm from Western drugmakers that dominate that market.
The other shoe has dropped for an Emcure Pharmaceuticals plant in India. After banning most of the sterile products coming out of the plant last year, the FDA has now issued a warning letter that says the company routinely used "fraudulent" test data to move drugs through the manufacturing process.
The Delhi High Court granted a stay for the Indian unit of Abbott Laboratories and local firm Macleods Pharmaceuticals to respond to a regulator ban halting sales of products that fall under so-called fixed dose formulations that combine medicines, the Economic Times said.
It seems to be two steps forward, one step back for India's Lupin in its efforts to build its business in the U.S. A week after the drugmaker closed a deal that gets it its first U.S. manufacturing facility, another of its plants in India has been found lacking by the FDA.