Indian generic manufacturer Wockhardt has begun to feel the sting of an FDA ban on drugs made at two of its plants, with fourth quarter profits falling 78%. And worse may still be to come, with the FDA issuing a Form 483 to the facility in Illinois that is the engineroom of its U.S. business.
Over the past decade patent expiries have forced many Big Pharma to close production plants that supported decades of growth. With the current and next generations of small molecules and biologics raising the bar for manufacturing complexity, Eli Lilly, Merck and their peers face a choice: build plants or outsource?
With the list of generic drugmakers in the FDA's bad books growing longer by the week, how to improve evaluation of its drugs was a top priority when the agency recently compiled its regulatory science goals.
To the casual observer, the International Conference on Harmonisation (ICH) could appear to be a fusty but uncontroversial group. Yet ICH's position in the highly charged debate over how quality standards affect the cost and availability of drugs--coupled with its links to the pharma industry--have made it a target of criticism.
Continuous manufacturing can reduce cycle times and make drug production more environmentally friendly, but it has yet to replace batch production in any significant way. Chemical & Engineering News revisited the benefits of continuous manufacturing and dug into why it has yet to take off in a feature this week.
Jubilant will use some of the cash to improve its generic drug manufacturing plants in India while also tapping the bank's emerging market healthcare expertise.
German company Fresenius has had multiple runs with the FDA in recent years, with the agency hitting its plants in the U.S., Puerto Rico and India with warning letters. Fresenius' Montreal, Canada, plant has caused it fewer problems, but it too has now encountered quality-control failings.
Over the past 18 months, India's SeQuent Scientific has won FDA approval of its API plant, sold its specialty chemicals business and acquired a stake in Shasun Pharma. The Bangalore-based business is maintaining the pace and further bolstering its API production business by agreeing to buy Arvee Synthesis.
When the FDA issued an import alert against Sun Pharma's plant in Gujarat in March, the drugmaker reassured investors the facility accounted for just 1% of U.S. sales. But with the allegations of failings at the plant becoming more and more damning, the FDA is reportedly following its now-familiar strategy of going after other facilities in the network.
Authorities recovered drugs worth $31.4 million, arrested 237 people worldwide and were able to close down 10,603 websites over a 10-day crackdown.
The FDA has been harping at the industry to make sure it gets its manufacturing right and Moderna Therapeutics, which is developing a way to enable the in vivo production of therapeutic proteins, intends to make sure it does.
The company is recalling about 40,000 bottles of drugs manufactured for it by Emcure Pharmaceuticals in India for deviations in lab testing, an issue the FDA has frequently uncovered at Indian plants.
The FDA this week sent U.S. Marshals into an Ohio warehouse to seize more than $11 million worth of drugs marketed by Ascend Pharmaceuticals which it claims are unapproved. But a mention in the FDA press release that the drugs were warehoused by Masters Pharmaceutical has brought a world of pain down on the third-party logistics company.
In the face of FDA actions against some of India's biggest drugmakers and a barrage of criticism of its regulators, the Indian government and industry have already responded with a PR campaign, and now India says it will spend more than $500 million to double its inspection staff and upgrade capabilities.
Merck KGaA has been investing steadily in its manufacturing operations the last couple of years, and now a fill-finish plant in Italy is slated to get a €50 million infusion as Merck forges ahead in preparation for selling more biologic drugs.
An FDA warning letter for a now banned Sun Pharmaceutical plant in India shows employees routinely deleted records of batch failures then retested drugs, reporting they met the standards that they previously couldn't hit.
The FDA talks a lot about how working with other countries, sharing information and insights, can allow it to stay on top of of the ever-expanding global supply chain while working within a finite budget. But even with Europe, whose geography includes countries as different as the U.K. and Romania, it can be harder to walk the walk than to talk the talk.
More growth in its manufacturing operations helped pharma services company WuXi PharmaTech to another strong quarter.
Abbott gets a portfolio of 1,000 new drugs and expects to see its sales in the Latin American market double with its $3 billion buyout out of Chile's CFR Pharmaceutical.
French contract manufacturer Novasep says that its expansion of its highly potent active pharmaceutical ingredients manufacturing operations at its plant in Le Mans, France, is complete, signed off on by the FDA and now being scaled up for commercial use.