Fistulin

Fistulin — Trade/Clinic Specification (India)

AYUSH-GMP • 10 ml / 30 ml • Professional Use • Highly Flammable (91.4% ethanol)

Product Overview

Fistulin is a proprietary homeopathic formulation prepared under AYUSH-GMP. This page summarizes label indications, composition, packaging, quality documentation, and logistics for professional supply.

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Label Indications (verbatim)

• Fistula
• Sinus
• Fissure
• Fistulas ulcer of long standing

Use consistent with the product label and applicable regulations.

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Dosage (label)

• Standard: 10 drops in a tablespoon of water once a week, or as advised by the physician

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Composition & Potency

Actives (per ml label):

• Silicea 30C — 0.40ml
• Calcarea fluorica 30C — 0.30ml
• Hepar sulphur 30C — 0.30ml

Vehicle: High-concentration pharmaceutical-grade ethanol
Alcohol content: 91.4% v/v
Manufacturing standard: Prepared per HPI in an AYUSH-GMP facility.

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Packs & Trade Data

Pack size	SKU	GTIN-13 / EAN
10 ml	FIST-010	________________
30 ml	FIST-030	________________

Label elements present: Product name, composition, potency, batch no., Mfg/Exp dates, storage, cautionary statements, manufacturer details.

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Case Pack & Carton Logistics

Pack size	Units / master carton	Carton dimensions (cm)	Gross wt. (kg)
10 ml	48	__ × __ × __	__.__
30 ml	24	__ × __ × __	__.__

• Palletisation: Specs available on request
• HSN: 3004.90 (confirm at dispatch)
• Ethanol (v/v): 91.4% (per label)

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Storage & Handling

• Store below 25 °C, protected from light and heat sources.
• Keep container tightly closed; keep away from strong odours.
• Highly flammable (91.4% ethanol content).
• Keep out of reach of children.
• Store in well-ventilated area away from ignition sources.

:::danger Highly Flammable Liquid: Keep away from heat/sparks/open flames/hot surfaces. No smoking. Ground/bond container and receiving equipment. Use explosion-proof equipment. Take precautionary measures against static discharge. :::

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Regulatory & Compliance

• AYUSH-GMP: Yes
• Manufacturing documentation: Master formula, batch manufacturing records, change control retained per QMS
• Label compliance: As per Drugs and Cosmetics rules (India); includes mandatory cautionary statements and storage
• Intended audience: Registered practitioners, licensed clinics/hospitals, authorized pharmacies/dispensaries
• Transport classification: Flammable liquid (UN1170) - special handling required

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Quality Control & Documentation

Batch documentation available to professional customers (on request / behind login):

• COA (Certificate of Analysis) per batch
• MSDS/SDS with flammability data
• Stability summary (where applicable)
• Traceability documentation

Routine QC (summary):

• Identity checks (source verification, Silicea authentication)
• In-process controls per HPI/QMS
• Finished product checks: organoleptic, ethanol % (v/v), potency verification, label accuracy, traceability
• Flammability and flash point testing
• High-potency remedy stability monitoring

Access documentation via the professional portal or request from QA with batch number.

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Supply & Dispatch (Logistics)

• Cut-off for same-day dispatch (stocked lines): 14:00 IST
• Typical dispatch window: 2–7 business days India-wide (flammable goods routing)
• Couriers (dangerous goods certified): BlueDart DG, Professional Couriers (limited routing)
• Transport packaging: UN-approved packaging; dangerous goods labeling; special handling protocols

For shipment coordination and documentation support, contact the professional/QA desk with your batch number and destination details.

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Marketing & Professional Materials

Available to professional customers (on request / behind login):

• High-resolution pack images (10 ml / 30 ml)
• Product specification sheet (PDF)
• Clinical reference guide for fistula and sinus management
• Storage & handling poster (A4) with safety protocols
• Safety data sheet (MSDS)
• Dangerous goods transport guide

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Frequently Asked (Trade)

• How do I obtain a COA/MSDS? Provide the batch number to the QA desk or use the professional portal.
• What are the transport restrictions? High ethanol content requires dangerous goods certification; contact logistics for routing options.
• What is the typical treatment duration? Dosing is once weekly for chronic conditions; treatment duration should be determined by the practitioner based on clinical response.
• Is there a topical form available? Yes, Fistulin Oil is available separately for external application in fistula and fissure conditions.
• What shelf-life do shipments carry? Shipments typically maintain ≥80% of labeled shelf-life remaining unless otherwise specified.
• Can I confirm GTIN/EAN for cataloguing? See the Packs & Trade Data table above; QA can re-confirm if needed.

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Document Information

Last Updated: October 23, 2025
Document Version: 1.0
Review Date: May 23, 2026

Professional Contacts (documentation & QA):

• QA/Docs: docs@pbmp.in (include product + batch no.)
• General Information: info@pbmp.in
• Dangerous Goods Shipping: logistics@pbmp.in

Disclaimer: This document is intended for healthcare professionals and authorized trade customers. It does not constitute medical advice. All information aligns with product labeling and applicable regulations. Use per professional judgment and local law. Handle as dangerous goods per transport regulations.