Elite Pharmaceuticals, Inc. (ELTP.OB) announced that it received approval as of September 28th from the U.S. Food and Drug Administration for generic phentermine capsules 15 mg and 30 mg.
Elite also announced that the sole supplier of the active pharmaceutical ingredient or "API" approved for this phentermine capsule product has restricted the amount of API available to Elite and this will delay the launch of this product.
Elite said that the supply restriction also prevents the company, and its sales and marketing partner, from meeting growing demand for the phentermine 37.5 mg tablets and is also expected to restrict sales of this product.
Elite said it believes the supplier is wrongfully limiting supply. If Elite is unable to timely resolve this dispute in a reasonable manner then, unless and until Elite is able to obtain adequate amounts of API, it will not be able to sustain or grow the sales of the generic phentermine products.
Elite noted that it has begun to qualify an alternative supplier, but qualification of an alternative supplier, due to FDA requirements, will entail a significant amount of time and could be expected to take 12 months or longer.
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