Able unable to meet investors

Related tags Paracetamol Attention-deficit hyperactivity disorder

The manufacturing compliance problems affecting US generic drug
manufacturer Able Laboratories, which have prompted a huge recall
of its entire product range, show little signs of being resolved,
reports Phil Taylor.

On Friday, Able cancelled its scheduled shareholders' meeting - scheduled for 8 July - at which it had been scheduled to give an update on its manufacturing woes. The result? Another 16 per cent carved off the share price, which is now languishing at around $3.52, down from nearly $25 before news of the recall broke in May.

Able was forced to cease all its manufacturing and recall products after major problems emerged with its quality control procedures at its manufacturing plant in mid May, prompting the resignation of CEO Dhananjay Wadekar. Since then, the company has announced sweeping job cuts, cutting around half its workforce of 420 staff.

In its latest statement, Able said that it needed to focus its resources on addressing its previously disclosed regulatory issues, including its recall of all products and its suspension of all manufacturing operations.

The US Food and Drug Administration (FDA) has advised consumers to stop taking medicines made by Able - of course after seeking the advice of their physician - and has even listed all the recalled drugs on its website.

In 2004, Able manufactured over 1.3 billion tablets, capsules, and suppositories and its plant in New Jersey, and is part way through building a second facility. Its top products lines included generic versions of the painkillers Ultram (tramadol), Vicodin and Lortab (both acetaminophen and hydrocodone), Darvocet (propoxyphene), Fioricet (butalbital, acetaminophen, and caffeine) and Tylenol (acetaminophen) with codeine; methylphenidate for attention deficit hyperactivity disorder; and various other drugs.

Able said it is continuing to review the issues with the FDA, other government agencies and consultants and is "evaluating all potential strategic options available."

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