USFDA okays Aurobindo Pharma's Pantoprazole Injections

The Dollar Business Bureau

The USFDA (United States Food and Drug Authority), a regulator, has approved Aurobindo Pharma's Pantoprazole sodium, in 40 mg per single-dose injection vials. The Abbreviated New Drug Application (ANDA), is classified under the Protonix IV category, a similar product approved for Wyeth Pharmaceuticals.

The generic drug is sold in multiple combinations under various brands in the form of capsules, injectable and oral suspension. Though considered a lucrative product, the estimated market size, according to IMS, the largest vendor of US' physician-prescription data, is $93.5 million for the twelve months ending February 2016. The drug, among 26 others that have received a confirmed ANDA approval would be manufactured at Hyderabad. Aurobindo has a total of 249 ANDA approvals, and 36 additional which await a USFDA nod for ANDA approval. The Indian pharmaceutical major received 3 approvals in Q4'15, for Tranexamic acid, Levetiracetam, and Isosulfan Blue. The approval on Pantoprazole was anticipated earlier within the fourth quarter, but this development has come in late by the end of this quarter.

The USFDA website, explains Aurobindo Pantoprazole, as a "selective-proton-inhibitor", that reduces the amount of acid within the stomach. The drug heals acid-related stomach and intestinal refluxes. The drug can be administered orally, through capsules as well as in injection formats. It has been recommended for adults as well as adolescents over 12 years. Though the drug is available over-the-counter, a physician's guidance is mandated in the event a patient is allergic to proton pump inhibitors or Pantoprazole-based medicines.

Aurobindo has one of the largest R&D facilities in India. Over 650 scientists, 35 PhD-holders with considerable expertise in product development, drug formulation and custom manufacturing are available. The Hyderabad-headquartered pharmaceutical giant has three research centers spread over 16,000 sq m. As per industry sources, and also transcript of a Feb'16 analyst-report available on the company's website, the development is bound to drive valuable forex.