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.
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