Contract pharma manufacturing market worth $84B by 2020

More pharma companies are trying to gain competitive advantage in contract pharmaceutical manufacturing by focusing on research and development of drugs, rather than getting involved in the production side, according to a new report from Research and Markets.

The analysis suggests that the global market for contract pharmaceutical manufacturing will be worth as much as $84 billion by 2020, up from $58 billion in 2014. This represents a compound annual growth rate of 6.4 percent over the forecast period.

A variety of factors are driving the growth of pharmaceutical outsourcing, including the increasing consumption of medicines around the globe, aging population, growing rate of approvals, adoption of novel manufacturing technologies, rising demand for generic drugs, robust pipeline of drugs and the increasing number of patents expiring. Challenges facing the industry include the increasing complexity of clinical trials and lack of in-house laboratory capacity, Research and Markets said.

Compounder banned from producing drugs due to adulterating & misbranding

A federal judge has entered an order of permanent injunction against a man who owned and operated numerous compounding pharmacies in Florida over the past 20 years.

The U.S. Food and Drug Administration (FDA) alleged that Paul W. Franck manufactured and distributed drug products that were adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In 2014, Franck’s Trinity Care Solutions recalled all sterile drugs and ceased compounding operations after FDA inspectors found violations including the presence of dead spiders, beetles, ants, wasps and cockroaches in the ceiling panel directly above the area where employees prepared for sterile processing.

In 2012, contaminated ophthalmic drugs compounded by Franck’s Compounding Lab were linked to at least 47 cases of eye infections, including at least 39 cases of temporary or permanent vision loss, the FDA reported.

And in 2009, 21 polo ponies died after receiving a drug product compounded by Franck’s Compounding Lab that contained 100 times the amount of selenium that should have been administered.


AMRI expands its API business with Italian acquisition

Contract research and manufacturing organization AMRI (Albany Molecular Research Inc.) has agreed to acquire Italy-based active pharmaceutical ingredients (API) manufacturer Prime European Therapeuticals, also known as Euticals, for approximately $358 million in stock, cash and a seller note.

Euticals specializes in custom synthesis and the manufacture of APIs. It operates a network of API facilities primarily in Italy, Germany, the U.S. and France.

AMRI expects this acquisition to enhance its capabilities in custom and complex APIs, expanding its expertise in multiple areas, including sterile APIs, steroids, generics, fermentation, controlled substances and monobactams. The acquisition is forecast to be accretive to AMRI’s 2016 non-GAAP diluted earnings per share.