Last month, Becton Dickinson ($BDX) got FDA approval for its antihistamine diphenhydramine hydrochloride injection, the first sterile injectable drug to come out of its new $100 million plant in North Carolina. The company crowed that it intended to bring out 20 to 30 drugs in the next few years. Three weeks later, product number two has gotten the FDA nod, indicating it wasn't just marketing bravado.
The second drug to come out of the new plant will be metoclopramide injection, USP, an injectable antiemetic. BD's niche is its prefilled syringe products in the most common doses used in hospitals and surgical centers. It expects to get a premium for its products which it sells as safer and more convenient than competitors' drugs.
"We're excited to be coming out with a second drug that is commonly used by clinicians," said Mark Sebree, president of BD Rx, the company's drug production unit. "This is just the beginning of our new line of prefilled injectable products."
The products are being produced at a 115,000-square-foot plant in Wilson, NC, which opened in 2010, according to Colleen White, BD's communications director. The plant currently employs more than 115 people and is expected to grow to about 140 by the end of 2013.
The sterile injectables market is growing worldwide, even as some of the established players like Hospira ($HSP) and Boehringer Ingelheim's Ben Venue Laboratories are struggling with manufacturing issues and FDA approvals in the U.S. That has opened up lucrative opportunities for players that have taken particular advantage of drugs, like Metoclopramide, which are in short supply. According to the FDA shortage list, Hospira currently has some of the drug available and Teva Pharmaceutical Industries ($TEVA) has decided to bring its version back to the market by the third quarter of this year.
Teva in October opened a $110 million, 15,000-square-meter facility plant in Gödöllő, Hungary, to make sterile injectables. Generic drugmaker Mylan ($MYL) was so taken with the upside of injectables that it recently agreed to pay $1.6 billion for India's Agila Specialties, which has modern and extensive injectables manufacturing.
- here's the release
- see the FDA shortage listing