Merck's manufacturing network continues to take a beating as the drugmaker acts on its $2.5 billion cost-cutting manifesto which is slated to claim 8,500 positions worldwide in the face of patent losses and revenue shortfalls. Next up, two facilities in Puerto Rico.
Drugmakers outside the U.S. continue to feel the sting of warning letters as FDA inspections of foreign facilities roll on. The most recent foreign plant to come up short is one in Madrid, Spain.
The FDA is seeking 100 volunteers for its Secure Supply Chain Pilot Program that would allow them an easier path for product deliveries if they agree to certain standards.
Chilean drugmaker CFR Pharmaceuticals last week made a $1.3 billion cash-and-share offer for South African drugmaker Adcock Ingram. By filling up Adcock's excess manufacturing capacity and combining their API purchasing power, CFR believes it can reduce production costs.
Fresenius Kabi, the generic drug unit for the German healthcare company, this week received an FDA warning letter for a plant in India. The company said it is dealing with the issues, but its work on the plant will not affect its previous guidance. The company is still expecting its net income to grow 7% to 12% for the year.
Apprehensions have been mounting over the EU Directive on Falsified Medicines, which goes into effect today, but India's exporters are sitting pretty.
The FDA has issued final guidance that spells it out so that there will be no repeat of the problems 5 years ago when dozens of Americans died because of contaminated products.
U.S. API makers couldn't imagine that the European Commission would not give them a pass on the new rule for proving that their manufacturing is equal to standards in Europe. But it took almost up to the last minute for regulators to acknowledge it.
Almac is expanding its contract manufacturing presence in Ireland, spending about $21.5 million to bolster a production facility and add 229 jobs.
With just weeks to go, one India government agency has just laid out the guidelines for API makers to follow in order to meet the new EU standards for certifying APIs that go into effect on July 2.