November 7, 2023 : Glenmark Pharmaceuticals, a leading global generics, and specialty pharmaceutical company, has received final approval from the United States Food and Drug Administration (USFDA) for its generic formulation of Chlorpromazine Hydrochloride Tablets USP, in the strengths of 10 mg, 25 mg, and 50 mg, 100 mg, and 200 mg. This approval marks a significant milestone for Glenmark as it expands its portfolio of generic drugs in the United States.
Chlorpromazine Hydrochloride, commonly known as Thorazine, is a phenothiazine-based antipsychotic medication primarily used to treat schizophrenia and other psychotic disorders. It works by blocking dopamine receptors in the brain, helping to reduce hallucinations, delusions, and other symptoms of psychosis.
Glenmark’s generic Chlorpromazine Hydrochloride Tablets are bioequivalent to the reference-listed drug, Thorazine, ensuring that it provides the same efficacy and safety profile as the brand-name medication. This approval will provide patients with an affordable alternative for treating schizophrenia and other psychotic disorders.
The USFDA approval of Glenmark’s generic formulation of Chlorpromazine Hydrochloride Tablets is a significant development for the company and patients alike. Glenmark’s proven track record of developing high-quality generic drugs and its commitment to expanding its portfolio makes it a valuable player in the US pharmaceutical market.
The approval of this generic formulation will increase competition in the antipsychotic medication market, potentially leading to lower drug prices for patients. This is particularly important for patients with chronic conditions like schizophrenia, who often require long-term treatment with these medications.
Glenmark’s USFDA approval for its generic formulation of Chlorpromazine Hydrochloride Tablets is a testament to the company’s dedication to providing affordable and effective treatment options for patients with schizophrenia and other psychotic disorders. This approval is a positive step towards ensuring patients have access to the medications they need to manage their conditions and improve their quality of life.