9. Fresenius Kabi

2014 Generics Sales: $2.3 billion +0%
Worldwide Market Share: 3.1%

Having spent the past couple of years dealing with FDA warning letters at plants in the U.S., Puerto Rico and India, German generics unit Fresenius Kabi slipped one position among 2014's global generics companies and landed in ninth place.

On the year, Fresenius Kabi saw its generics sales stay flat, bringing in $2.3 billion in both 2013 and 2014. Stagnant sales, coupled with an expanding market, led the company's market share to fall from 3.3% in 2013 to 3.1% in 2014.

During the period, the generics unit of Fresenius completed 41% of its sales in Europe, 30% in North America, 19% in Asia-Pacific and 10% in Latin America/Africa.

Sure to have impacted the generics maker last year were the several FDA warning letters it received for plants in Grand Island, NY; Kalyani, India; and Puerto Rico throughout 2012 and 2013. The agency upgraded the New York facility earlier this year and is currently waiting for FDA reinspection at the other two. In the meantime, it has moved production elsewhere.

In executing on an emerging markets focus, it was able to purchase Brazil's Novafarma Industria Farmaceutica, a deal which is part of the company's "strategy to expand its market presence and product portfolio" in such areas, Fresenius board chair Dr. Ulf Schneider said in the company's year-end report. To add to that, the unit acquired two companies in Ecuador to expand its position and portfolio there.

However, ambitions to expand production capacity in Russia were stymied due to political turmoil last year. In canceling the deal with prospective partner Binnopharm, the pair said they'd look for other ways to work together. Earlier, however, Fresenius Kabi did see some good news through a grant in Australia to help pay for a new $47 million manufacturing plant on the island continent. It also got a boost from the FDA which allowed it to import saline in the midst of a national shortage.

Looking forward, Schneider said in the letter that worldwide drug pricing scrutiny will create opportunities for the company in generics, especially in emerging markets which have seen demand for generics grow "much faster" than in the U.S. and Europe. China's market for generic IV drugs is growing by more than 10% per year, Schneider added, but such products are only a small part of Fresenius Kabi's business there so far.

"To take advantage of this growth opportunity, we have opened a development center for oncological generics in Wuhan that will enable us to respond more quickly to the needs of this key market," Schneider said. "We plan to file a large number of drug approval applications with Chinese regulators in the coming years and will produce drugs in the country."

Not helping so far in 2015, though, was an $844,600 fine Fresenius Kabi and a sister company received from U.K. authorities due to manufacturing lapses tied to a patient death at a hospital there. The patient died in a Sheffield hospital of organ failure triggered by diabetic ketoacidosis because Fresenius sold syringes that contained no insulin.

-- Eric Sagonowsky (email)

For more:
Fresenius Kabi, Calea fined $844,600 for lapses tied to patient death
Fresenius closes out recall started two years ago
Fresenius expansion plans in Russia sidelined by political turmoil
Fresenius awaiting FDA reinspection at plants in NY, India
FDA lets Fresenius import saline to help with shortage
Fresenius to build new plant in Australia
Former Fresenius employee says he was fired for raising red flags

9. Fresenius Kabi

Suggested Articles

In a departure from the usual approval process, the FDA says it doesn't require manufacturing inspections before weighing vaccines for emergency use.

Sanofi and Regeneron released follow-up data from a phase 3 trial for immunology blockbuster Dupixent in an eosinophilic esophagitis.

Singapore has suspended the use of two flu vaccines, from SK Bioscience and Sanofi, amid reports of deaths in South Korea after immunization.