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Pharmaceutical industry

Glenmark Generics Receives Final ANDA Approval for Norethindrone Tablets

Strategic Insights

— 1 min read

Glenmark Generics Inc., USA, a subsidiary of Glenmark Pharmaceuticals, has been granted final approval by the United States Food and Drug Administration (U.S.FDA) for its generic version of Micronor tablets, a progestin-only oral contraceptive. This is the company's third female hormonal product approval and second approval for an oral contraceptive. Glenmark's previous approvals include the Heather tablets, a generic version of Nor-QD tablets by Watson, and Norethindrone Acetate. Notably, Glenmark remains the only Indian company to have received ANDA approval for a female hormonal product and an oral contraceptive.

Key Takeaways:

  • Glenmark Generics Inc., USA has been granted final ANDA approval for Norethindrone tablets 0.35 mg, a generic version of Micronor tablets by Ortho McNeil Jassen Pharmaceuticals Inc.
  • This is Glenmark's third female hormonal product approval and second approval for an oral contraceptive.
  • Glenmark previously received approval for Heather tablets, a generic version of Nor-QD tablets by Watson, and Norethindrone Acetate.
  • Glenmark remains the only Indian company to receive ANDA approval for a female hormonal product and an oral contraceptive.
  • This approval is a significant milestone for Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, which aims to be a global integrated generic and API leader.

Statistics:

  • Glenmark Generics has received three female hormonal product approvals, including two oral contraceptives.
  • Glenmark remains the only Indian company to have received ANDA approval for a female hormonal product and an oral contraceptive.
  • The Norethindrone tablets 0.35 mg are indicated for the prevention of pregnancy and are the progestin-only oral contraceptive.

Sources:

  • Glenmark Generics' subsidiary, Glenmark Generics Inc., USA, has been granted final ANDA approval from the United States Food and Drug Administration (U.S.FDA) for Norethindrone tablets 0.35 mg, their generic version of Micronor tablets by Ortho McNeil Jassen Pharmaceuticals Inc.
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