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ANFARM HELLAS S.A. sell "Omeprazole Gr.Cap 20mg & 40mg (EU CTD Available)"

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Basic Information

124
7
2
4.5(63)

Trade Type

Sell

Product Name

Omeprazole Gr.Cap 20mg & 40mg (EU CTD Available)

Manufacturer(s)

Specifications

  • Indication: Proton-pump inhibitor (PPI) providing marked, long-lasting reduction of stomach acid production, referencing Losec®/AstraZeneca.
  • Dosage Form: Gastro-resistant capsule, intended for the labeled route of administration.
  • Storage Conditions: Store below 25°C in a dry place, protected from direct sunlight, in the original tightly closed packaging.

Other Information

Additional Description:

Available as 20 mg and 40 mg gastro-resistant omeprazole capsules, referencing Losec®/AstraZeneca. Omeprazole belongs to the proton-pump inhibitor (PPI) class, which markedly and durably reduces stomach acid production; PPIs' potent acid-suppressing effect supports approval for numerous indications, including short-term management of GERD, erosive esophagitis, H. pylori, and duodenal and gastric ulcers, as well as long-term use for NSAID-associated gastric ulcers, hypersecretory conditions, and maintaining healed erosive esophagitis. An EU CTD dossier is available, with stability studies for Zone II/IVb, shelf life of 24 months (20 mg) and 36 months (40 mg), batch sizes of 213,675 capsules (20 mg) and 100,000 capsules (40 mg), and packs of 14 and 28 capsules.
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