Indian pharmaceutical powerhouse, Marksans Pharma has achieved a significant milestone, securing the coveted US Food and Drug Administration (FDA) nod for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets in both 600 mg and 1200 mg concentrations. These breakthrough tablets are confirmed to be bioequivalent to the acclaimed Mucinex Extended-Release Tablets of the […]
Marksans Pharma said that it has been granted final approval for the over-the-counter (OTC) use of Famotidine Tablets USP, 10 mg and 20 mg from the US Food and Drugs Administration (FDA). Famotidine Tablets is bioequivalent to Pepcid AC tablets, said the India-based pharma company. The reference listed drug (RLD) is owned by Johnson & […]
Marksans Pharma has secured final approval for its abbreviated new drug application (ANDA) for Pregabalin Capsules from the US Food & Drugs Administration (FDA). The approval is for the 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths of Pregabalin Capsules. It is indicated in relieving pain […]
Marksans Pharma Limited said that its fully-owned subsidiary Relonchem Limited has secured market authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Loperamide 2mg hard capsules. The Indian pharma company will manufacture the Loperamide 2mg hard capsules at its oral dosage facility in Goa. The facility has the approval of the UK […]