GeoPharma Receives FDA Approval To Manufacture Carprofen
GeoPharma has received an approval from the FDA to begin producing Carprofen.
Commonly marketed by Pfizer as Rimadyl, Carprofen is a non-steroidal anti-inflammatory drug (NSAID) that is used by veterinarians for the relief of pain and inflammation associated with osteoarthritis in dogs. Additionally, Carprofen is often used in the treatment of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.
"This is a major step forward in the company's tactical plans to offer generic drugs," stated GeoPharma CEO Mihir K. Taneja. "We are tremendously pleased to have received final approval on Carprofen from the FDA for both the company and our shareholders. GeoPharma has anticipated this approval and is well prepared to have its arrival begin to translate into sales and net income almost immediately. This is the first of what we anticipate will be many approvals for GeoPharma. We continue to be enthusiastic about our drug pipeline which holds 12 ANDAs and other drug products in various stages of development and the approval process. It is our hope to receive additional approvals by the end of our fiscal year on other drugs, as well as a production approval of our dedicated 100,000 Sq. Ft. Beta Lactam manufacturing facility located in Baltimore, Maryland," added Mr. Taneja.
The company detailed its plans to produce Carprofen in three strengths 25 mg, 75 mg, and 100 mg caplets, allowing for appropriate dosing and cost effective pain management for the animals. Furthermore, the company reiterated its strategic commitment to aggressively pursue attractive generic drug and medical device opportunities wherever they present themselves.