Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"
The generic ED pills sell for five cents less than Pfizer's branded blue pill, but the undercutting is a bit deeper.
The new rules are expected to do away with the haphazard nature of facility inspections.
Drug quality problems and shortages are behind the shift that will affect antibiotics, painkillers and vitamins.
The drug maker is reportedly talking low rates for India's market.
The generics drugmaker tells Bloomberg the hassle is not worth it.
The company releases 2014 guidance Tuesday, but signals from the previous 12 months indicate the Indiana drugmaker is determined to hit its $20-billion earnings target, patent losses be damned.
The Japanese drugmaker's Israeli operation marks its sixth new sales outpost this year.
The catch is the difference between sales and revenues. Generics will continue to be a force, and small-audience drugs will become increasingly important.
Domestic manufacturers are being pressured to offer domestic discounts to international clients.
GlaxoSmithKline second-quarter sales rose 2% over the same period last year. CEO Andrew Witty says it is too early to tally the impact of China's corruption allegations.
Indian health regulators recently banned Takeda's Actos, a perplexing move that could set a new precedent in the country.
An agency bellwether, PHCG is hoping to return to growth after a tame 2012, its CEO said this week.
Roche and Isis pair up for Huntingtons, Vital's prescription vision app gets approved, FDA approval revives maligned morning sickness drug, Gilead sends hep C therapy to regulators and Sanofi's emerging market exposure grabs attention.
Execs told Booz & Co researchers that the relationships web in emerging markets needs to be deeper than one-on-one sales pitches.
From tech shifts to talent, and from emerging markets to engaging with social media, agency execs offer their predictions for what the New Year will bring.
The amount of revenue pharma leaves on the table due to non-adherence is much more than previously thought, a new study suggests.
A global study of consumer attitudes towards health found evidence for the "empowered consumer" hypothesis, with respondents expressing a greater sense of control over and responsibility for their health.
Merck and GSK are both increasing the number of sales reps operating in China, according to separate presentations given by the two companies. In both cases, added reps in emerging markets are helping to offset significant reductions in US sales forces, company executives said.
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- Apple's ResearchKit: Five Guidelines for Pharma