Drotaverine Hydrochloride Tablets 40mg

Drotaverine Hydrochloride Tablets 40mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Drotaverine Hydrochloride Tablets IP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Drotaverine Hydrochloride Tablets IP 40mg
  Each uncoated tablet contains:
  Drotaverine Hydrochloride IP.……………………40mg
  Excipients……………………………………………………q.s

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.
Tablets to be swallowed as a whole, and not to be chewed or crushed. 

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 to Drotaverine Hydrochloride Tablets 40mg

Drotaverine Hydrochloride Tablets 40mg are a well-known antispasmodic medication used widely for pain relief caused by smooth muscle spasms. This formulation effectively relieves menstrual pain, abdominal pain, pain due to kidney stones, biliary colic, and gastrointestinal cramps.

Taj Pharma, the reputed Drotaverine Hydrochloride Tablets 40mg Manufacturer in India, ensures unmatched purity, quality, and consistency in every tablet. As a trusted name in the global pharmaceutical export market, Taj Pharma produces Drotaverine Tablets under strict international quality guidelines.

Drotaverine works by inhibiting the phosphodiesterase enzyme, increasing cAMP levels in smooth muscles, and promoting relaxation, thereby relieving pain without affecting normal body functions like blood pressure or heartbeat.

The global demand for Drotaverine Hydrochloride Tablets 40mg is steadily increasing due to its wide therapeutic use and effectiveness in both acute and chronic spasmodic conditions.

2.  India’s Trusted Drotaverine Hydrochloride Tablets 40mg Manufacturer

Taj Pharma Ltd, headquartered in Vapi, Gujarat, India, is a leading Manufacturer, Exporter, and Supplier of Drotaverine Hydrochloride Tablets 40mg. With WHO-GMP and ISO certifications, Taj Pharma is recognized for consistent quality, affordable pricing, and global compliance standards.

Their commitment to excellence in manufacturing has earned Taj Pharma recognition across Africa, the Middle East, Asia, Latin America, and CIS countries.

Taj Pharma’s Drotaverine Hydrochloride Tablets 40mg are manufactured in state-of-the-art facilities equipped with modern technology, ensuring optimal quality, efficacy, and patient safety.

3. Composition, Uses, and Benefits

Composition:
Each film-coated tablet contains:

• Drotaverine Hydrochloride – 40mg

Dosage Form: Tablet
Therapeutic Class: Antispasmodic

Primary Indications:

• Menstrual pain (Dysmenorrhea)

• Abdominal pain

• Pain due to kidney stones (Renal colic)

• Biliary stone pain

• Gastrointestinal cramps

• Smooth muscle spasms

Mechanism of Action:
Drotaverine acts by inhibiting phosphodiesterase (PDE-4), increasing cyclic AMP levels, and reducing smooth muscle contractility. This leads to effective relief from pain caused by spasms.

Benefits of Drotaverine Hydrochloride Tablets 40mg:

• Provides quick pain relief without sedation

• Non-narcotic and non-addictive

• Does not affect cardiovascular or respiratory systems

• Suitable for long-term use under medical supervision

4. Regulatory Documentation and Export Readiness for Buyers

For global importers, distributors, and PCD franchise partners, Taj Pharma offers a complete regulatory and export documentation package for Drotaverine Hydrochloride Tablets 40mg, ensuring smooth international trade and regulatory approval.

Regulatory Support Includes:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• CTD/ACTD Dossier

• Free Sale Certificate

• Stability Data (Zone III & IV)

• MSDS, Batch Manufacturing Record (BMR), and Validation Reports

Packaging & Labeling:

• Blister packs / Alu-Alu packs

• Custom branding available for private label buyers

• Packaging designed for humidity and temperature protection

Storage & Shelf-life:

• Store in a cool, dry place, away from direct sunlight

• Shelf-life: 24–36 months depending on regulatory requirements

Dosage Form:

• Oral solid dosage (tablet)

• Available in 10×10 or custom configurations

Taj Pharma’s regulatory documentation and export expertise enable global buyers to register Drotaverine Hydrochloride Tablets 40mg in their home markets effortlessly.

5. Export Certifications and Compliance

Taj Pharma’s manufacturing units are certified by:

• WHO-GMP (World Health Organization – Good Manufacturing Practice)

• EU-GMP (European Union GMP Compliance)

• ISO 9001:2015 Quality Management System

• FDA (India) Approved Facilities

These certifications ensure Taj Pharma’s Drotaverine Hydrochloride Tablets 40mg meet stringent international standards for efficacy, safety, and quality consistency.

6. Target Export Markets and Global Presence

Taj Pharma proudly exports Drotaverine Hydrochloride Tablets 40mg to over 70+ countries worldwide.

Top Export Destinations Include:

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

This vast export network solidifies Taj Pharma’s reputation as a global leader in Drotaverine Hydrochloride Tablets 40mg export from India.

7. Why Taj Pharma is the Most Trusted Drotaverine Hydrochloride Tablets 40mg Manufacturer and Exporter

State-of-the-Art Manufacturing

Taj Pharma’s ultra-modern plants at Vapi, Gujarat are fully automated, ensuring precision, hygiene, and contamination-free production.

Quality Assurance

Each batch undergoes stringent in-process checks, microbial testing, and stability studies. Taj Pharma adheres to ICH Q10 and WHO guidelines, ensuring international compliance.

Affordable Pricing

Taj Pharma provides cost-effective pricing without compromising on quality — making it ideal for bulk buyers, government tenders, and private distributors.

Global Supply Chain

Efficient logistics and packaging ensure timely deliveries and compliance with international shipping standards (GDP-compliant).

Comprehensive Regulatory Support

Taj Pharma assists importers with complete dossier preparation, registration, and post-approval documentation, easing market entry for international buyers.

8. Technical Product Specification Table

9. Partner with Taj Pharma Today

If you’re an importer, distributor, or PCD pharma franchise looking for a reliable Drotaverine Hydrochloride Tablets 40mg Manufacturer in India, Taj Pharma is your ideal partner.

With WHO-GMP-certified manufacturing, full regulatory support, and a proven export track record, Taj Pharma ensures global buyers receive unmatched product quality and prompt supply assurance.

📞 Contact Taj Pharma Ltd, Vapi, Gujarat, India
🌐 Website: www.tajpharma.com
✉️ Email: info@tajpharma.com

10. Top 20 FAQs 

1. What is Drotaverine Hydrochloride Tablets 40mg used for?
It’s an antispasmodic medication used to relieve pain from smooth muscle spasms such as menstrual pain, kidney stones, and abdominal cramps.

2. Who manufactures Drotaverine Hydrochloride Tablets 40mg in India?
Taj Pharma Ltd is one of the leading WHO-GMP-certified manufacturers and exporters of Drotaverine Hydrochloride Tablets 40mg in India.

3. Is Drotaverine safe for long-term use?
Yes, it can be used under medical supervision without risk of addiction or sedation.

4. Can pregnant women take Drotaverine?
It is not advisable during pregnancy unless prescribed by a healthcare professional.

5. What are the common side effects?
Mild effects include nausea, vomiting, dizziness, or dry mouth — usually temporary and self-resolving.

6. What is the dosage of Drotaverine Hydrochloride Tablets 40mg?
As prescribed by a doctor, typically 1 tablet two to three times a day.

7. What is the mechanism of action?
It inhibits PDE-4 enzyme, increasing cAMP, resulting in smooth muscle relaxation.

8. Does Taj Pharma export Drotaverine Tablets globally?
Yes, Taj Pharma exports to over 70 countries worldwide.

9. What certifications does Taj Pharma have?
WHO-GMP, EU-GMP, ISO 9001:2015, and COPP certifications.

10. What is the shelf life of Drotaverine Tablets 40mg?
Usually between 24–36 months.

11. What packaging options are available?
Alu-Alu, blister packs, or custom packaging as per buyer needs.

12. How should the tablets be stored?
Store in a cool, dry place below 30°C.

13. Can Drotaverine be used for children?
Only under medical supervision with proper dosage guidance.

14. Is it available under PCD pharma franchise?
Yes, Taj Pharma offers PCD franchise opportunities across India.

15. What makes Taj Pharma’s Drotaverine Tablets unique?
High purity, GMP-compliant production, and global export quality.

16. Does Taj Pharma offer private labeling?
Yes, customized branding and packaging options are available.

17. What is the mode of shipment for export?
By air or sea, depending on order volume and destination.

18. Are sample batches available?
Yes, upon request for regulatory submission or evaluation.

19. How long does export documentation take?
Typically within 2–3 weeks after order confirmation.

20. How to get a quotation?
Contact Taj Pharma via their website or email for detailed price and MOQ