Submit detailed rationale for developing Pantoprazole modified dosage form: CDSCO panel tells Lupin
New Delhi: In response to drug-maker Lupin's proposal of manufacturing and marketing Pantoprazole enteric coated delayed release tablets 40 mg (Modified Dosage form), the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has asked the firm to submit the detailed rationale for developing the product.
The SEC expert committee has suggested that the company submit a detailed reason for developing this product, including the benefits and drawbacks of this proposed formulation over the existing formulation supported by literature.
This came after Lupin presented the proposal for the manufacturing and marketing of Pantoprazole enteric coated delayed release tablets of 40 mg (Modified Dosage form) along with the bioequivalence (BE) study protocol.
Pantoprazole is a first-generation proton pump inhibitor (PPI) used for the management of gastroesophageal reflux disease (GERD), for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of NSAIDs, and for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome.
Available brands of PANTOPRAZOLE 40MG in India are Cipla's Pantix 40 Mg Tablet 10s, Abbott India's Pandiff 40 Mg Injection, Sun Pharma's Pantocid-40 Tab, Alkem's Pan-40 Tab and others.
At the latest SEC meeting for Gastroenterology & Hepatology, the committee thoroughly examined Lupin's proposal for manufacturing and marketing of Pantoprazole enteric coated delayed release tablets, 40 mg (Modified Dosage form).
After detailed deliberation, the committee recommended that the firm submit the detailed rationale for developing this product along with the advantages and disadvantages of this proposed formulation over the existing formulation supported by literature.
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To mention, Lupin's research program covers the entire pharma product chain. The company's R&D program is headquartered in the Lupin Research Park located near Pune and Aurangabad that houses over 1,400 scientists. Lupin's R&D covers Generics Research, Process Research, Pharmaceutical Research, Advanced Drug Delivery Systems (ADDS) Research, Intellectual Property Management, Novel Drug Discovery and Development (NDDD), Biotechnology Research.
