Sun Pharmaceutical subsidiary Taro Pharmaceuticals was the one bright spot in the Indian-based drugmaker's Q3 fiscal universe reported late last week.
Federal authorities hoped to make an example of the owner of a small Connecticut pharma manufacturing operation that they said ignored warnings and had polluted waste water dumped into the sewers.
South Korea's Samsung BioLogics has pledged to be a big deal in biosimilars, but so far its biologics subsidiary has produced mostly operating losses for its parent. In anticipation of turning that around, the company will undertake a significant expansion of the biologics plant in Songdo, Incheon, that it opened in 2013.
Sun Pharmaceutical's revenues have taken a double whammy from quality problems the FDA cited at a plant in India. The drugmaker said they were down, both because of the costs of fixing the plant and because the of supply interruption from that effort.
Sixty-four jobs are at risk as a result of AMRI's proposal to close an API plant in Wales. A final decision for the plant will come after a consultation with employees and discussions on ways to reduce "redundancies" at the former Excelsyn facility.
Companies with the ability and capacity to manufacture sterile injectable drugs are becoming popular targets. The injectables business of Claris Lifesciences is now said to be drawing attention from potential buyers.
Actavis says it needs to concentrate on integrating the manufacturing network it will soon get from Allergan and so decided to sell back to private equity investor TPG a small piece of Aptalis. TPG sold Aptalis to Forest Laboratories a year ago just ahead of Forest's buyout by Actavis.
Videos touting manufacturing processes are again being used by a drugmaker to help launch a new product: GlaxoSmithKline's new over-the-counter version of allergy fighter Flonase, which appeared on retailers' shelves this week.
Three years out, French drugmaker Sanofi continues to reap benefits from having opened a U.S. biologics plant that added capacity for some of the rare disease meds developed by its Genzyme unit.
Hospira said on Tuesday that it was recalling more than 60 lots of the pain reliever ketorolac tromethamine injection in the U.S. and Singapore just 5 days after Pfizer said it would pay $15 billion for the specialist in sterile injectable drugs. In fact, on the day the deal was announced, the FDA announced a Hospira recall of the sedative propofol.
Federal authorities have extracted another guilty plea from a doctor found to be using unapproved foreign versions of drugs on his patients, including Rituxan, Remicade and Prolia. The Kentucky physician, who bought the drugs at a deep discount from the U.K., will pay more than half a million dollars in restitution and has received a year of probation.
Canada will now require drugmakers to report drug shortages, a practice that has been voluntary. But a new report from Pew Charitable Trusts says solving the problem of drug shortages will require a multipronged attack by regulators, payers and the industry.
After more than a year of upgrades, GSK says it believes Nicorette Mini Lozenges will be on retailers' shelves in April and full size later this year. It is none too soon for dedicated users of the over-the-counter product, who have been scrounging for them since supplies began to dry up.
Enteris BioPharma, which was formed in August 2013, will offer contract manufacturing after investing about $1 million into its 32,000-square-foot, FDA-approved manufacturing plant where it makes active pharmaceutical ingredients (APIs) up to commercial scale using microbial expression systems.
Cipla, which has been building beachheads and production capacity in hot spots where most Western drugmakers are loath to go, will now create a joint venture in Morocco and build a drug manufacturing facility there.
SINGAPORE--The China FDA ordered Shangdong Qidu Pharmaceutical to recall 21,700 bottles of an injectable API combination for treating respiratory, urinary and reproductive infections. The agency said impurities "similar to furs" were found in sampled bottles.
Count another Indian API producer on the FDA's regulatory radar. Four months after issuing an import ban on products made at a Micro Labs plant in Bangalore, the agency outlined the violations last month.
U.S. contract manufacturer Cambrex is ready to again expand a plant in Iowa. It will invest about $50 million for manufacturing and warehouse operations there and also plans to put money into sites in Sweden and Italy.
Vertex Pharmaceuticals is building a $30 million, 4,000-square-foot continuous manufacturing facility in Boston in anticipation that it will get approval for a new cystic fibrosis drug.
Wockhardt Chairman Habil Khorakiwala claims the company has satisfied FDA concerns laid out in a Form 483 by inspectors last year for a plant in Morton Grove, IL.