Granules India Secures USFDA Approval for Generic Pantoprazole Sodium Tablets

The company clarified that these tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg, and 40 mg strengths, of Wyeth Pharmaceuticals LLC.

Hyderabad-based Granules India Limited, a leading Indian pharmaceutical company, has received approval from the US Food & Drug Administration (USFDA) for its generic pantoprazole sodium delayed-release tablets. 

These tablets are utilised for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD).

The approval covers the abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets with strengths of 20 mg and 40 mg. The company clarified that these tablets are bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg and 40 mg strengths, of Wyeth Pharmaceuticals LLC.

Pantoprazole sodium delayed-release tablets are specifically designed for addressing erosive esophagitis linked to GERD, a condition characterised by the backward flow of stomach acid causing heartburn and potential esophageal injury. Additionally, the medicine is indicated for the maintenance of healing of erosive esophagitis and pathological hypersecretory conditions, including Zollinger-Ellison (ZE) syndrome.

According to data from IQVIA/IMS Health (MAT Oct 2023), the current annual market for pantoprazole tablets in the US is estimated to be around USD 233 million.

Granules India Limited, established in 1991 and headquartered in Hyderabad, operates as a vertically integrated pharmaceutical company, covering active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).

In a related development, Granules India Limited had previously received USFDA approval for its Sildenafil for oral suspension, 10 mg/mL, indicated for treating pulmonary arterial hypertension (PAH) in adults. The drug aims to enhance exercise capacity and delay clinical deterioration.

Furthermore, in related approvals, Zydus, another prominent Indian pharmaceutical company, gained USFDA approval for its Methylene Blue injection, available in 10mg/2ml and 50mg/5ml formulations. This injection, classified as an oxidation-reduction agent, is indicated for treating paediatric and adult patients with acquired methemoglobinemia.

Additionally, Zydus Lifesciences has secured final approval from the USFDA for its generic Ivabradine tablets, used in treating heart failure. The approved tablets, with strengths of 5 mg and 7.5 mg, will be manufactured at the company's formulation manufacturing facility in Ahmedabad SEZ, India.