Sun Pharmaceutical Industries Ltd has informed about the Press Release of Caraco Pharmaceutical Laboratories Ltd, i.e. Companys U. S. subsidiary company dated September 26, 2007, as follows :
Caraco Pharmaceutical Laboratories, Ltd, (Amex: CPD) on September 26, 2007 has announced that the US Food and Drug Administration (FDA) has granted final approval for the Companys Abbreviated New Drug Application (ANDA) for Methimazole Tablets USP, 5 mg and 10 mg (Methimazole).
Methimazole is indicated in the medical treatment of hyperthyroidism. Caracos Methimazole is therapeutically equivalent to the FDA reference listed drug (RLD) listed in the Orange Book, Methimazole Tablets USP, 5 mg and 10 mg, respectively. According to IMS Data, for the twelve months ended June 2007, Methimazole had annual sales of approximately $21 million.
Daniel H. Movens, Caracos Chief Executive Officer, said, We are pleased to receive this approval from the FDA. This marks the third approval in the last 30 days and the sixth approval this quarter. This is in addition to the two tentative approvals granted by the FDA during the period. One of the main drivers of our growth is to continue to expand and strengthen our product portfolio. This will bring our total product selection to 41different products represented by 86 various strengths.
Detroit-based Caraco Pharmaceutical Laboratories Ltd, develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nations largest wholesalers, distributors, drugstore chains and managed care providers.
Caraco Pharmaceutical Laboratories, Ltd, (Amex: CPD) on September 26, 2007 has announced that the US Food and Drug Administration (FDA) has granted final approval for the Companys Abbreviated New Drug Application (ANDA) for Methimazole Tablets USP, 5 mg and 10 mg (Methimazole).
Methimazole is indicated in the medical treatment of hyperthyroidism. Caracos Methimazole is therapeutically equivalent to the FDA reference listed drug (RLD) listed in the Orange Book, Methimazole Tablets USP, 5 mg and 10 mg, respectively. According to IMS Data, for the twelve months ended June 2007, Methimazole had annual sales of approximately $21 million.
Daniel H. Movens, Caracos Chief Executive Officer, said, We are pleased to receive this approval from the FDA. This marks the third approval in the last 30 days and the sixth approval this quarter. This is in addition to the two tentative approvals granted by the FDA during the period. One of the main drivers of our growth is to continue to expand and strengthen our product portfolio. This will bring our total product selection to 41different products represented by 86 various strengths.
Detroit-based Caraco Pharmaceutical Laboratories Ltd, develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nations largest wholesalers, distributors, drugstore chains and managed care providers.
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