Description
Loperamide Tablet
Loperamide Hydrochloride Tablets USP / BP / IP (2 mg)
High-Velocity Peripheral Mu-Opioid Receptor Anti-Diarrheal
Healthy Life Pharma Private Limited, alongside our specialized global export and marketing division Healthy Inc, is a leading Indian manufacturer, CDMO partner, and wholesale exporter of advanced gastroenterology, internal medicine, and over-the-counter (OTC) public health therapeutics. We manufacture ultra-high-purity, structurally stable Loperamide Hydrochloride Tablets inside our state-of-the-art, WHO–GMP certified, high-capacity solid dosage manufacturing complexes.
Serving as the frontline therapeutic cornerstone for the immediate stabilization of acute diarrheal episodes, this essential public health commodity represents a high-velocity strategic export to retail pharmacy distribution franchises, travel health immunization centers, national institutional tenders, and international digital B2B marketplaces across Sub-Saharan Africa, the CIS region, LATAM, and South-East Asia.
Product Overview
This formulation operates as an “Intestinal Peristalsis Decelerator & Fluid Reabsorption Optimizer.” It ensures immediate gastrointestinal stabilization and prevents critical dehydration during acute diarrheal distress by directly dampening hyperactive gut motility signals.
Mechanism 1 (Peripheral Mu-Opioid Receptor Activation): Loperamide physically targets and selectively binds to $\mu$-opioid receptors located on the circular and longitudinal smooth muscle layers of the intestinal wall. It acts strictly peripherally and does not cross the blood-brain barrier at therapeutic doses, eliminating central narcotic side effects.
Mechanism 2 (Peristaltic Velocity Deceleration): By activating these local receptors, it chemically inhibits the release of Acetylcholine and Prostaglandins from the mesenteric plexus. This physical blockade immediately slows down the frequency and intensity of peristaltic contractions, expanding the transit time of intestinal contents.
Mechanism 3 (Fluid & Electrolyte Reabsorption Boost): The extended intestinal transit window allows the mucosal lining to physically reabsorb trailing water, sodium, and essential electrolytes from the fecal mass. This increases stool viscosity, decreases fecal volume, and reduces the life-threatening risk of acute systemic dehydration.
Product Composition & Configuration
We supply Loperamide Hydrochloride in the internationally standardized 2 mg therapeutic dosage configuration, engineered for rapid disintegration and fast symptomatic relief.
| Active Ingredient Monograph | Calibrated Strength | Formulation Delivery Matrix | Primary Clinical Application |
| Loperamide Hydrochloride USP / BP / IP | 2 mg | Oral Solid Immediate-Release Uncoated Tablet | Fast-Acting Anti-Diarrheal: Non-specific acute diarrhea management, chronic diarrheal stabilization, and ileostomy output reduction. |
| Excipients | Pharma Grade | Lactose Monohydrate, Microcrystalline Cellulose, Corn Starch, Magnesium Stearate | The Disintegration Scaffold: Optimized matrix for high mechanical stability and rapid water wicking. |
Technical & Logistics Specifications
HS Code: 3004.90.39 (Medicaments acting on the alimentary tract / Anti-diarrheals) or 3004.90.99 (General Category)
CAS Number: 34552-83-5 (Loperamide Hydrochloride) / 53179-11-6 (Loperamide Base)
Dosage Form: Oral Solid Tablet (Engineered as compact, easy-to-swallow micro-tablets)
Packaging Configurations:
OTC & Retail Packs: 4 / 6 / 10 / 20 Tablets per Blister Strip packed in high-barrier Alu-Alu (Cold-Form Foil) or silver PVC/PVDC strips (optimized for standard 2-to-4 day acute travel diarrheal cycles).
Institutional Tenders: Bulk packs of 100 / 500 / 1000 Tablets per induction-sealed HDPE Bottle to minimize baseline unit and freight costs for national public health ministries. Our premium tropicalized packaging completely prevents environmental moisture transit, guaranteeing a full 36-month shelf life in hot, humid Zone IVb export environments.
Advanced Manufacturing Integrity & Quality Controls
High-Velocity Multi-Million Unit Compression: To satisfy heavy volume procurement demands and urgent international relief tenders, we utilize high-speed rotary press blocks equipped with Automated Forced-Feeder Die Matrices and Electronic Weight Variation Regulators, physically ensuring absolute content uniformity across continuous high-output million-unit production runs.
Zero-Carryover Cleanroom Separation: Although Loperamide operates entirely peripherally, it belongs to the chemical piperidine class. To satisfy strict international B2B regulatory audits, our processing lines utilize Dedicated Cleanroom Blocks equipped with isolated differential pressure systems, completely eliminating the risk of active chemical carryover into other manufacturing lines.
Rapid Disintegration Kinetics Verification: Every single production batch physically undergoes automated multi-pH dissolution profiling, chemically validating that our generic tablets achieve immediate disintegration (under 3 minutes), ensuring fast systemic absorption and rapid clinical intervention.
Primary Indications
Gastroenterology: Symptomatic control and relief of acute, non-specific diarrhea and chronic diarrheal conditions associated with Inflammatory Bowel Disease (IBD).
Surgical Adjuvant: Reduction of fecal volume and optimization of stool consistency in patients presenting with an Ileostomy.
Usage Instructions
The Initial Induction Protocol: For acute diarrheal stabilization in adults, the standard protocol demands an initial induction dose of two tablets (4 mg) taken orally immediately, followed by one tablet (2 mg) after each subsequent unformed or loose bowel movement.
The Daily Ceiling Limit Rule: Advise clinical and retail distribution networks that the standard maximum daily dosage for adults must never exceed 16 mg (8 tablets) within a 24-hour window.
Hydration Reinforcement Requirement: Loperamide addresses the physical motility symptom of diarrhea but does not replace fluid loss. It is clinically mandatory to administer this therapeutic alongside comprehensive Oral Rehydration Salts (ORS) to completely neutralize the risk of dehydration.
Safety Warning: POTENT PERIPHERAL ANTI-DIARRHEAL. For Professional and OTC Supervision Guidelines Only. The Toxic Megacolon Warning: Do not utilize as a primary clinical management tool if diarrhea is accompanied by high fever or bloody stools (acute dysentery). Halting motility under these conditions chemically traps invasive bacterial pathogens (Salmonella, Shigella, Campylobacter) or C. difficile toxins inside the intestinal lumen, physically risking Toxic Megacolon, intestinal perforation, and systemic sepsis. Cardiac Misuse Note: High dosages far exceeding standard therapeutic ceilings can cause severe cardiac conduction abnormalities ($QT$ prolongation / Torsades de Pointes); strictly enforce approved label protocols. Absolute Contraindications: Absolute contraindications in pediatric patients aged less than 2 years, acute ulcerative colitis, pseudomembranous colitis related to broad-spectrum antibiotics, bacterial enterocolitis, or known hypersensitivity to loperamide matrices.
Global CDMO Services & Wholesale Tender Supply
Healthy Life Pharma Private Limited and Healthy Inc provide complete, internationally validated Third-Party Contract Manufacturing (CDMO Services) and bulk private-label export pipelines for the entire Loperamide Hydrochloride portfolio. Because this molecule faces zero controlled-substance dual-licensing hurdles, our high-capacity lines can rapidly manufacture, release, and ship multi-container shipping loads. We handle all mandatory documentation (WHO-GMP Certificate, Certificates of Pharmaceutical Product – COPP, Certificates of Analysis – COA, Stability Testing Matrix Sheets, and Complete CTD Format Dossier sets) for seamless entry registration.
Commercial & Bulk Procurement Inquiries:
Corporate Head Office: Mumbai, Maharashtra, India
Primary Manufacturing Base: Boisar, Maharashtra, India
WhatsApp / Direct Call: +91 7710003340
Corporate Email: info@healthyinc.co.in
