GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Hyoscine Butylbromide Tablets BP 10mg
2. Hyoscine Butylbromide Tablets BP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Hyoscine Butylbromide Tablets BP 10mg
Each sugar coated tablet contains:
Hyoscine Butylbromide BP…………..10mg
Excipients…………………………………….q.s
Color: Sunset yellow FCF


2. Hyoscine Butylbromide Tablets BP 20mg
Each sugar coated tablet contains:
Hyoscine Butylbromide BP……………20mg
Excipients………………………………………q.s
Color: Alizarin cyanine green F

THERAPEUTIC INDICATIONS:

Hyoscine Butylbromide is an antispasmodic drug indicated for the treatment of abdominal pain associated with cramps induced by gastrointestinal (GI) spasms.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Store in a dry place.
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Hyoscine Butylbromide Tablets 10mg Technical Specification:

Product Name: Hyoscine Butylbromide Tablets BP
Brand Name: Generic
Strength: (10mg), (20mg)
Dosage Form: Tablets (sugar coated)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Analgesic, Muscle Relaxant, Gastroenterological
Indication: Hyoscine Butylbromide is an antispasmodic drug indicated for the treatment of abdominal pain associated with cramps induced by gastrointestinal (GI) spasms.
Storage: Store at 20° to 25°C (68° to 77°F). Store in dry place.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Hyoscine Butylbromide Tablets BP 10mg
2. Hyoscine Butylbromide Tablets BP 20mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Hyoscine Butylbromide Tablets BP 10mg
Each sugar coated tablet contains:
Hyoscine Butylbromide BP…………..10mg
Excipients…………………………………….q.s
Color: Sunset yellow FCF

2. Hyoscine Butylbromide Tablets BP 20mg
Each sugar coated tablet contains:
Hyoscine Butylbromide BP……………20mg
Excipients………………………………………q.s
Color: Alizarin cyanine green F

THERAPEUTIC INDICATIONS:

Hyoscine Butylbromide is an antispasmodic drug indicated for the treatment of abdominal pain associated with cramps induced by gastrointestinal (GI) spasms.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Store in a dry place.

Dosage: As directed by the Physician

Introduction to Hyoscine Butylbromide Tablets 10mg

Hyoscine Butylbromide Tablets 10mg is a well-known anticholinergic medication used to treat pain and discomfort caused by smooth muscle spasms in the stomach, intestines, bladder, and ureter. It is also highly effective in relieving the symptoms of Irritable Bowel Syndrome (IBS) and other gastrointestinal conditions.

Taj Pharma, the leading Hyoscine Butylbromide Tablets 10mg manufacturer in India, offers premium-grade formulations that ensure efficacy, safety, and consistency for global buyers. Manufactured at the company’s WHO-GMP-certified facility in Vapi, Gujarat, Taj Pharma’s Hyoscine Butylbromide Tablets are formulated with precision under stringent quality controls.

This medicine works by relaxing the muscles in the stomach and gut (intestine), reducing painful cramps, spasms, bloating, and discomfort. It acts by blocking the effects of acetylcholine, thereby preventing involuntary muscle contractions.


Global Demand and Market Potential

The global pharmaceutical market for antispasmodic and gastrointestinal medications has seen consistent growth due to rising incidences of abdominal cramps, IBS, and urinary tract-related discomfort. Hyoscine Butylbromide Tablets 10mg remains one of the most prescribed drugs for such conditions worldwide.

India, known as the “Pharmacy of the World,” plays a vital role in fulfilling global demand for affordable yet high-quality formulations. Taj Pharma Ltd, with decades of manufacturing excellence, has emerged as one of the top Hyoscine Butylbromide Tablets 10mg exporters from India, supplying to more than 80 countries across Africa, Asia, Latin America, and the Middle East.


Detailed Information for Importers, Exporters & Buyers

Taj Pharma provides complete technical, regulatory, and export support to international clients. The company ensures smooth registration, export documentation, and customized packaging to meet country-specific regulatory needs.

Regulatory Documentation Provided

  • WHO-GMP Certificate

  • Certificate of Pharmaceutical Product (COPP)

  • Certificate of Analysis (COA)

  • CTD / ACTD Dossier

  • Free Sale Certificate (FSC)

  • Stability Data (Zone-wise)

  • Batch Manufacturing Records (BMR)

  • Analytical Method Validation (AMV)

Custom Packaging & Labeling Options

  • Alu-Alu / Blister / Strip Pack formats available

  • Custom labeling for regulatory compliance

  • Export-oriented packaging with tamper-proof seals

  • Multilingual labeling for specific countries

  • Private Label and OEM (contract manufacturing) options

Dosage Form, Shelf Life & Storage

  • Dosage Form: Film-coated tablets

  • Strength: Hyoscine Butylbromide 10mg

  • Shelf Life: 24–36 months

  • Storage: Store below 30°C, in a cool, dry, and dark place

Export Certifications

  • WHO-GMP Certification

  • ISO 9001:2015 Certified

  • EU-GMP Compliant Facilities

  • COPP (Certificate of Pharmaceutical Product)

  • GLP & GDP Certified

  • Dossier Support (CTD/ACTD Format)

Target Export Markets

Taj Pharma’s export network spans 80+ countries, including:

  • Africa: Nigeria, Kenya, Ghana, Tanzania, Ethiopia

  • Middle East: UAE, Saudi Arabia, Iraq, Yemen, Jordan

  • Asia-Pacific: Sri Lanka, Vietnam, Philippines, Myanmar

  • CIS & Europe: Ukraine, Russia, Georgia, Armenia

  • Latin America: Peru, Bolivia, Ecuador, Chile


Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

1. WHO-GMP Certified Manufacturing Excellence

Taj Pharma’s production facility in Vapi, Gujarat, is a modern, WHO-GMP-compliant plant adhering to international pharmaceutical manufacturing standards. Each batch of Hyoscine Butylbromide Tablets 10mg undergoes multiple levels of quality assurance and process validation.

2. Quality Assurance and Purity

Taj Pharma ensures unmatched product consistency and purity. The QA/QC team performs comprehensive testing for dissolution, stability, uniformity, and microbial safety to meet IP/BP/USP pharmacopeial standards.

3. Affordable and Competitive Pricing

Taj Pharma is committed to offering affordable pricing without compromising on quality. Global buyers and PCD Pharma franchise partners benefit from competitive costs, robust packaging, and strong regulatory backing.

4. Strong Global Presence

Taj Pharma has a global footprint in over 80 countries, making it one of the most reliable Hyoscine Butylbromide Tablets 10mg exporters from India. The company’s international regulatory expertise ensures seamless compliance and timely delivery.

5. End-to-End Regulatory Support

Taj Pharma provides complete technical support — from dossier preparation and COPP issuance to custom labeling and country registration. This makes it the preferred partner for international importers, government tenders, and institutional buyers.


Top 20 Countries Exporting 

Country Region Regulatory Status
Nigeria Africa Registered
Kenya Africa Registered
Ghana Africa Registered
Tanzania Africa Registered
Ethiopia Africa Registered
Vietnam Asia Under registration
Sri Lanka Asia Registered
Philippines Asia Registered
Cambodia Asia Registered
UAE Middle East Registered
Iraq Middle East Registered
Saudi Arabia Middle East Registered
Yemen Middle East Registered
Ukraine Europe Registered
Russia CIS Registered
Georgia CIS Registered
Peru South America Registered
Bolivia South America Registered
Chile South America Registered
Myanmar Asia Registered

Technical Product Specification 

Parameter Specification
Product Name Hyoscine Butylbromide Tablets 10mg
Manufacturer Taj Pharma Ltd., Vapi, Gujarat, India
Dosage Form Tablet
Strength 10mg
Composition Each tablet contains Hyoscine Butylbromide 10mg
Pharmacopoeia Standard IP / BP / USP
Packaging 10×10 Tablets / Customizable
Shelf Life 24–36 Months
Storage Conditions Store below 30°C in a dry place
Certifications WHO-GMP, ISO 9001:2015, COPP, GLP
Export Formats CTD / ACTD Dossier
Regulatory Support Full Documentation for Product Registration
Market Availability PAN India and Global Exports

Dosage, Administration & Usage Instructions

  • Take Hyoscine Butylbromide Tablets 10mg exactly as directed by your physician.

  • It can be taken with or without food, preferably at the same time each day.

  • Do not skip doses and complete the full course as prescribed.

  • Avoid consuming alcohol while on medication.

  • Use caution while driving or performing tasks requiring focus, as the medicine may cause dizziness or drowsiness.


Precautions, Side Effects, and Warnings

Common Side Effects:

  • Nausea, Constipation, or Dry Mouth

  • Dizziness and Sleepiness

  • Hypotension (Low Blood Pressure)

  • Sweating, Blurred Vision

  • Abdominal Pain, Flatulence, or Bloating

Serious but Rare Side Effects:

  • Heartburn, Depression, Confusion

  • Allergic Skin Reactions (Rash, Itching)

  • Agranulocytosis or Decrease in Blood Cells

Precautions:

  • Use with caution in patients with kidney, liver, or heart disorders.

  • Not recommended during pregnancy or breastfeeding unless prescribed.

  • Ensure adequate hydration to avoid dehydration due to diarrhea.

PAN India Manufacturing & PCD Franchise Opportunities

Taj Pharma is a PAN India manufacturer and supplier of Hyoscine Butylbromide Tablets 10mg, offering PCD Pharma Franchise and third-party manufacturing services. The company caters to domestic distributors, government supply chains, and export clients.

With a strong base in Mumbai, Maharashtra, and advanced WHO-GMP-approved plants in Vapi, Gujarat, Taj Pharma ensures consistent quality, affordable pricing, and wide distribution across the Indian subcontinent and global markets.


Call to Action 

If you’re seeking a reliable and globally recognized Hyoscine Butylbromide Tablets 10mg Manufacturer in India, Taj Pharma is your trusted partner for excellence, compliance, and cost-effectiveness.

Contact Taj Pharma Ltd Today:
📍 Address: Vapi, Gujarat, India
🌐 Website: www.tajpharma.com
📧 Email: info@tajpharma.com

Why Choose Taj Pharma?
✅ WHO-GMP Certified Manufacturing
✅ Global Export Experience
✅ Affordable Pricing
✅ Full Regulatory & Dossier Support
✅ Custom Packaging & Private Label Services


Top 20 FAQs  

  1. What is Hyoscine Butylbromide 10mg used for?
    It’s used to relieve cramps and pain caused by smooth muscle spasms.

  2. Is Taj Pharma a WHO-GMP-certified manufacturer?
    Yes, Taj Pharma’s facilities are certified under WHO-GMP and ISO 9001:2015.

  3. Can this medicine be taken on an empty stomach?
    Yes, it can be taken with or without food.

  4. What is the shelf life of Hyoscine Butylbromide Tablets 10mg?
    Typically 24 to 36 months.

  5. Does Taj Pharma provide regulatory dossiers?
    Yes, complete CTD/ACTD dossiers are available.

  6. Which countries does Taj Pharma export to?
    Over 80 countries worldwide, including Africa, Asia, and Latin America.

  7. Are private label options available?
    Yes, OEM and private labeling are supported.

  8. Can it be used for IBS?
    Yes, it’s highly effective for Irritable Bowel Syndrome.

  9. Does it cause drowsiness?
    It may cause mild dizziness or drowsiness in some users.

  10. Is it safe for pregnant women?
    Consult your doctor before use during pregnancy.

  11. How does Hyoscine Butylbromide work?
    It blocks acetylcholine’s action to relax smooth muscles and relieve spasms.

  12. What are common side effects?
    Constipation, nausea, dizziness, and dry mouth.

  13. Is export documentation available?
    Yes, Taj Pharma provides COPP, FSC, COA, and GMP certificates.

  14. Does Taj Pharma offer third-party manufacturing?
    Yes, they offer full contract manufacturing services.

  15. Where is Taj Pharma located?
    Headquartered in Mumbai, with manufacturing in Vapi, Gujarat.

  16. What is the dosage strength available?
    10mg and 20mg formulations.

  17. Is it available for government tenders?
    Yes, Taj Pharma supplies to institutional and government procurement channels.

  18. How is it packaged?
    10×10 Blister or Alu-Alu packs, customizable per export market.

  19. Does Taj Pharma comply with international standards?
    Yes, including WHO-GMP, GLP, and EU-GMP.

  20. How can I place an order?
    Contact Taj Pharma via email or their website’s inquiry form.