Gabapentin Companies

Latest Gabapentin Companies Update

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  March 2023: Granules India Ltd., a pharmaceutical company, obtained authorization from the United States health regulator to market its generic gabapentin tablets, which are designed to treat postherpetic neuralgia in adults. Granules India stated in a regulatory filing that the US Food and Drug Administration (FDA) has granted approval for the abbreviated new drug application (ANDA) for Gabapentin tablets with concentrations of 600 mg and 800 mg. These tablets are bioequivalent to the reference listed drug product of Viatris Specialty LLC, Neurontin Tablets, 600 mg and 800 mg. The company added that gabapentin tablets are approved for the treatment of postherpetic neuralgia in adults and partial onset seizures, with or without secondary generalization, in adults and pediatric patients with epilepsy aged 3 years and older as an adjunctive therapy.

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  January 2023: The United States Food and Drug Administration (FDA) granted final approval to Glenmark Pharmaceuticals Limited (Glenmark), a research-driven multinational pharmaceutical company, for Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg. Tadalafil is the generic equivalent of Cialis®1 Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, manufactured by Eli Lilly and Company. Based on sales data from IQVIA™ for the twelve-month period concluding in November 2020, the market for Cialis® Tablets in the following strengths (2.5 mg, 5 mg, 10 mg, and 20 mg) generated an estimated annual revenue of $125.5 million*. Gabapentin Enacarbil Extended-Release Tablets, 300 mg and 600 mg, the generic equivalent of Horizant®1 Extended-Release Tablets, 300 mg and 600 mg, manufactured by Arbor Pharmaceuticals, LLC, have also been provisionally approved by the U.S. FDA for Glenmark.

• Zydus Pharmaceuticals, Inc


• Glenmark Pharmaceuticals Limited


• Sun Pharmaceutical Industries Ltd.


• Ascend Laboratories, LLC


• Apotex Inc.


• Teva Pharmaceutical Industries Ltd.


• Aurobindo Pharma.


• Amneal Pharmaceuticals LLC.


• Cipla USA, Inc.


• BP Pharmaceuticals Laboratories Company


• Assertio Holdings, Inc.


• Arbor Pharmaceuticals, Inc.


• Pfizer Inc.