Pantoprazole Tablets Manufacturer India

What We Manufacture

Pantoprazole Tablet — specifications & clinical context

Product Specifications

Generic Name	Pantoprazole Sodium Sesquihydrate
Strength / Dosage	20mg · 40mg
Dosage Form	Enteric-Coated Tablet
Route of Administration	Oral
Pack Size	Strip of 10 · Bottle of 100
Packaging	Alu-Alu cold form blister
Storage	Store below 25°C · Protect from moisture
Shelf Life	24 months
Manufacturing Facility	WHO-GMP Certified · Birkoni, Chhattisgarh
Regulatory Status	DCGI Approved · Manufacturing Licence Held
Available For	Contract manufacturing · Third-party manufacturing · Direct institutional supply

Clinical Context

Pantoprazole is one of the most prescribed drugs globally and the most prescribed PPI in India. On the WHO Essential Medicines List. Indicated for GERD, erosive oesophagitis, peptic ulcer disease, H. pylori eradication (triple therapy), Zollinger-Ellison syndrome and NSAID-related gastroprotection. The 40mg once-daily dose is the standard. Among the single highest-volume tablets in both government procurement and retail pharmacy in India.

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Why 9M India

How Pantoprazole Tablet is manufactured at 9M India

WHO-GMP certified manufacturing process

Pantoprazole EC tablets require technically precise enteric coating — the acid-labile Pantoprazole must be completely protected from gastric acid (0% dissolution at pH 1.2 for 2 hours) while releasing rapidly in the small intestine (>75% dissolution at pH 6.8 within 45 minutes). 9M India uses validated Eudragit L30D-55 or HPMCP-based enteric coating systems with weight gain monitoring per batch. Pantoprazole is also moisture and light-sensitive — Alu-Alu cold form blister mandatory.
In-house QC release testing — every batch

Acid resistance (0% dissolution at pH 1.2 for 2 hours) · Buffer dissolution (>75% at pH 6.8 in 45 min) · Assay by HPLC · Related substances · Water content · Microbial limits — all in-house.
Complete documentation within 24 hours

Manufacturing Licence · DCGI approvals · WHO-GMP Certificate · COA · COC · Stability data — pre-prepared, available within 24 hours.