Elite Pharmaceuticals has received FDA approval for supplemental application for the manufacturing and packaging of Hydromorphone Hydrochloride USP 8mg.
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The approval will allow the company to initiate the commercial manufacturing and packaging of the product for its sales.
The company’s marketing partner will distribute the product as part of a multi-product distribution agreement.
Hydromorphone hydrochloride is a member of the opioid analgesic and antitussive class which is used primarily for pain relief or as a cough suppressant.