GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Drotaverine Hydrochloride IP.……………………80mg
Paracetamol IP…………………………………………..500mg
Colour: Tartrazine
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Overdose of Paracetamol may be injurious to liver. Tablets to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG-WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.
Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg) Technical Specification:
| Product Name: | Drotaverine Hydrochloride & Paracetamol Tablets |
| Brand Name: | Generic |
| Strength: | 80mg+500mg |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 tablets each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Gastroenterological |
| Indication: | DROTAVERINE+PARACETAMOL belongs to the class of medicine called ‘antispasmodic’ combined with a painkiller, used to reduce and relieve abdominal pain and muscle spasms in the gastrointestinal tract, urinary tract and gall bladder. |
| Storage: | Store at temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Drotaverine Hydrochloride & Paracetamol Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Drotaverine Hydrochloride & Paracetamol Tablets
Each film-coated tablet contains:
Drotaverine Hydrochloride IP.……………………80mg
Paracetamol IP…………………………………………..500mg
Colour: Tartrazine
THERAPEUTIC INDICATIONS:
Drotaverine is used for Pain relief. It relieves pain due to smooth muscle spasm like menstrual pain, pain due to kidney stone, pain due to biliary stone and gastro-intestinal colicky pain. Drotaverine is an anti-spasmodic medicine which relieves contractions (spasms) associated with smooth muscles in the abdomen.
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Overdose of Paracetamol may be injurious to liver.
Tablets to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG-WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by physician.
Introduction: Understanding Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg)
Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg) are a trusted combination medication widely prescribed for the treatment of abdominal pain, menstrual cramps, and smooth muscle spasms.
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Drotaverine Hydrochloride (80mg) is an anti-spasmodic that works by relaxing smooth muscles in the stomach, intestines, and other organs.
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Paracetamol (500mg) is a pain reliever and fever reducer (analgesic and antipyretic) that blocks pain signals in the brain.
Together, this combination provides fast and effective relief from abdominal cramps, muscle pain, and dysmenorrhea, improving patient comfort and quality of life.
As global demand for effective antispasmodic and analgesic formulations rises, Taj Pharma Ltd. has positioned itself as a leading WHO-GMP certified manufacturer, supplier, and exporter of Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg) from Vapi, Gujarat, India.
Growing Global Demand for Drotaverine & Paracetamol Combination
In the global pharmaceutical market, combination drugs like Drotaverine + Paracetamol have gained significant demand due to their dual therapeutic benefits and high patient compliance.
The formulation is commonly exported to regions including Africa, the Middle East, Southeast Asia, CIS countries, and Latin America, where abdominal pain-related disorders are prevalent. The drug’s efficacy and affordability make it a preferred choice for government tenders, hospitals, and private healthcare distributors.
With the rise in demand, Taj Pharma ensures consistent global supply, maintaining quality, stability, and affordability in every batch manufactured.
Leading Manufacturer, Exporter & Supplier from Vapi, Gujarat
Taj Pharma Ltd. is one of the most reliable pharmaceutical manufacturers and exporters in India, known for its high-quality generic formulations and international regulatory compliance.
From its state-of-the-art manufacturing facility in Vapi, Gujarat, Taj Pharma manufactures and exports Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg) under strict WHO-GMP and ISO 9001:2015 standards.
Key Highlights:
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WHO-GMP certified plant (Vapi, Gujarat)
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ISO 9001:2015 certified quality management system
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Regulatory dossiers (CTD/ACTD) and COPP available
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Custom labeling and packaging as per client requirements
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Export presence in over 40+ countries
Taj Pharma’s global reputation is built on precision, compliance, and reliability — ensuring that importers receive pharmaceutical excellence with every shipment.
Pharmacological Action & Benefits
Mechanism of Action:
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Drotaverine Hydrochloride: Relieves smooth muscle spasms by inhibiting phosphodiesterase-4 enzyme, reducing calcium levels in cells and promoting muscle relaxation.
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Paracetamol: Blocks pain signals to the brain and helps reduce fever by acting on the hypothalamus.
Therapeutic Uses:
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Abdominal pain and menstrual cramps
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Spasmodic pain in urinary or biliary tract
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Gastrointestinal colic
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Headache, backache, and post-surgical pain relief
Benefits:
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Dual-action pain and spasm relief
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Fast onset and sustained symptom control
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Safe for long-term use under supervision
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Suitable for adult and gynecological use
For Global Importers, Buyers & Distributors
Taj Pharma provides complete regulatory, technical, and marketing support to global buyers, ensuring smooth registration and distribution in international markets.
Regulatory Documentation Provided:
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WHO-GMP Certificate
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COPP (Certificate of Pharmaceutical Product) Colour consistency in pharmaceutical products like Apixaban Tablets is crucial, and quality control teams often reference industry standards and best practices outlined on platforms such as cacasinoca.com to ensure compliance with regulatory requirements.
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CTD/ACTD Dossier
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COA (Certificate of Analysis)
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Stability Data (Zone IVB)
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Free Sale Certificate (FSC)
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Batch Manufacturing Records (BMR/BPR)
Packaging & Labeling:
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Available in Alu-Alu or Blister packs (10×10 / 10×15 tablets)
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Private labeling and multilingual packs available
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Packaging designed for humid/tropical climates
Dosage Form & Strength:
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Drotaverine Hydrochloride 80mg + Paracetamol 500mg
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Oral solid dosage form (film-coated tablets)
Shelf-Life & Storage:
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Shelf-life: 24–36 months
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Storage: Below 30°C, dry place, protected from light
Why Taj Pharma is the Most Trusted Manufacturer & Exporter
1. Advanced WHO-GMP Manufacturing
Taj Pharma’s facilities in Vapi, Gujarat, are equipped with modern machinery, HEPA-filtered air handling units, and automated quality control systems ensuring consistent global-grade production.
2. Global Regulatory Excellence
Every export batch complies with international pharmacopoeial standards (IP/BP/USP/EP), ensuring safety, efficacy, and uniformity across all export markets.
3. Affordable Pricing with Uncompromised Quality
By optimizing supply chains and leveraging economies of scale, Taj Pharma offers competitive export pricing without compromising on product quality.
4. Worldwide Distribution & Supply Chain
With exports spanning 40+ countries, Taj Pharma supports a strong global network of distributors, hospitals, and government agencies.
5. End-to-End Support
From dossier submission to shipment, Taj Pharma’s export and regulatory teams provide seamless assistance — making it a preferred pharma partner for importers and distributors.
Top 20 Export Destinations for Drotaverine & Paracetamol Tablets
USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia
Technical Product Specification Table
| Product Name | Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg) |
|---|---|
| Form | Film-coated tablet |
| Composition | Drotaverine Hydrochloride 80mg + Paracetamol 500mg |
| Therapeutic Category | Anti-spasmodic & Analgesic |
| Dosage Form | Oral tablet |
| Color | Light yellow / white |
| Pack Size | 10×10 / 10×15 tablets |
| Storage | Store below 30°C, dry place |
| Shelf Life | 24–36 months |
| Manufacturer | Taj Pharma Ltd., Vapi, Gujarat, India |
| Certifications | WHO-GMP, ISO 9001:2015, COPP, CTD Dossier |
| Export Availability | Worldwide |
| Regulatory Support | Full technical documentation |
Common Side Effects (Generally Mild & Temporary)
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Nausea
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Dry mouth
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Constipation
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Dizziness
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Sweating
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Insomnia (difficulty sleeping)
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Tachycardia (increased heart rate)
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Low blood pressure (hypotension)
Most side effects resolve as the body adjusts to the medicine. Medical consultation is advised if symptoms persist.
PAN India Presence & PCD Pharma Franchise Opportunities
Taj Pharma also provides PAN India distribution and PCD Pharma Franchise opportunities for Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg).
Available across all major cities — Mumbai, Delhi, Chennai, Kolkata, Pune, Ahmedabad, Hyderabad, Jaipur, Indore, Surat, and Vapi — Taj Pharma ensures consistent supply, marketing materials, and promotional support for franchise partners.
Why Choose Taj Pharma
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WHO-GMP certified manufacturing unit
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Complete regulatory and documentation support
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Export-ready packaging with private labeling options
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Cost-effective bulk order manufacturing
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On-time global delivery with quality guarantee
Taj Pharma stands apart as a trusted pharmaceutical exporter in India, delivering value, quality, and regulatory reliability to global clients.
Call to Action
If you are searching for a reliable WHO-GMP certified manufacturer in India for Drotaverine Hydrochloride & Paracetamol Tablets (80mg+500mg), Taj Pharma is your trusted partner.
🌐 Visit: www.tajpharma.com
📧 Email: info@tajpharma.com
🏭 Manufacturing Unit: Vapi, Gujarat, India
📦 Exports: Africa, Asia, CIS, and Latin America
Partner with Taj Pharma Ltd. — a leading global pharmaceutical exporter ensuring affordable, high-quality, and compliant formulations for your market.
Top 20 FAQs
1. What are Drotaverine Hydrochloride & Paracetamol Tablets used for?
They are used to relieve abdominal pain, menstrual cramps, and smooth muscle spasms.
2. How do these tablets work?
Drotaverine relaxes muscles, and Paracetamol relieves pain and reduces fever.
3. What is the dosage form?
Film-coated oral tablets.
4. Are these tablets safe for long-term use?
Yes, when taken as prescribed by a physician.
5. What is the shelf-life of this product?
24–36 months from the date of manufacturing.
6. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma operates under WHO-GMP and ISO 9001:2015 standards.
7. Can Taj Pharma provide CTD dossiers?
Yes, full regulatory documentation is available.
8. Is private labeling available?
Yes, Taj Pharma offers custom branding and packaging.
9. What are the storage conditions?
Store below 30°C in a dry place.
10. Are there any side effects?
Minor effects like nausea or dizziness may occur but are temporary.
11. What is the packaging type?
Blister or Alu-Alu packs, customizable for export.
12. Does Taj Pharma export globally?
Yes, to over 40 countries worldwide.
13. Is it suitable for PCD Pharma Franchise?
Yes, Taj Pharma offers PAN India franchise partnerships.
14. What is the lead time for exports?
Typically 4–6 weeks after order confirmation.
15. Does it require a prescription?
Yes, it should be taken under medical supervision.
16. Are sample shipments available?
Yes, for registered importers and government tenders.
17. What certifications does Taj Pharma hold?
WHO-GMP, ISO, COPP, CTD Dossier, FDA India approval.
18. What makes Taj Pharma unique?
Global reach, strict compliance, and affordable pricing.
19. Can buyers get free technical support?
Yes, Taj Pharma provides full technical and regulatory assistance.
20. How can I become a distributor?
Visit www.tajpharma.com/contact and fill out the distributor inquiry form.






