Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg)

Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Drotaverine Hydrochloride & Aceclofenac Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Drotaverine Hydrochloride & Aceclofenac Tablets
  Each film-coated tablet contains:
  Drotaverine Hydrochloride IP.……………………80mg
  Aceclofenac IP…………………………………………..100mg
  Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

ACECLOFENAC+DROTAVERINE is used to reduce and relieve abdominal pain which occurs between the chest and pelvic region (below the belly button and leg). Drotaverine works by relieving contractions associated with smooth muscles of the abdomen (belly).

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. 

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 to Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg)

Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) is a combination medicine widely used for the treatment of abdominal pain, cramps, and muscle spasms. It blends the properties of two powerful drugs—Drotaverine, an antispasmodic, and Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID).

This combination helps relieve pain, inflammation, and smooth muscle contractions in conditions like menstrual cramps, renal colic, biliary colic, and gastrointestinal spasms. It is one of the most prescribed formulations in gastrointestinal and gynecological therapy segments.

With growing global demand for safe and effective pain-relief combinations, Taj Pharma Ltd, based in Vapi, Gujarat, has become a top manufacturer, supplier, and exporter of Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) from India, serving healthcare systems worldwide with unmatched quality and reliability.

Mechanism of Action

• Drotaverine Hydrochloride (80mg):
  Works as an antispasmodic by inhibiting the enzyme phosphodiesterase IV, which increases cAMP levels in smooth muscle cells, leading to relaxation and relief from spasms.

• Aceclofenac (100mg):
  Functions as an anti-inflammatory and analgesic by blocking prostaglandin synthesis, the chemical messengers responsible for pain, swelling, and inflammation.

Together, they provide dual action relief—Drotaverine relaxes the muscles, while Aceclofenac reduces inflammation and pain.

Therapeutic Uses

• Abdominal pain and cramps

• Gastrointestinal colic

• Biliary colic

• Menstrual cramps (Dysmenorrhea)

• Postoperative abdominal discomfort

• Renal colic

• Spastic pain due to muscle contractions

Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) Manufacturer from Vapi, Gujarat, India

Taj Pharma Ltd is a WHO-GMP certified pharmaceutical manufacturer and exporter headquartered in Vapi, Gujarat, India. With advanced infrastructure and a global footprint, Taj Pharma is renowned for its commitment to quality, compliance, and affordability.

The company specializes in the production and export of Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) under stringent manufacturing and quality control processes, ensuring consistency, safety, and efficacy.

Key Highlights:

• WHO-GMP and ISO 9001:2015 Certified

• State-of-the-art facility with EU-GMP standards

• CTD/ACTD-compliant product dossiers

• Customized packaging and branding for export markets

• Strong supply chain network across 80+ countries

Side Effects and Precautions

Most patients tolerate Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) well. However, some may experience mild side effects such as:

• Nausea or vomiting

• Dizziness or vertigo

• Dryness of mouth

• Abdominal discomfort

• Diarrhea or constipation

• Indigestion

• Sweating or flushing

• Hypotension (low blood pressure)

• Fatigue or drowsiness

These effects usually resolve as the body adjusts to the medication. If they persist, consult your physician.

Precautions:

• Avoid alcohol while taking this medicine.

• Take with food to prevent stomach irritation.

• Use caution while driving due to possible drowsiness or dizziness.

• Avoid use in patients with severe liver or kidney disorders.

Dosage and Administration

• Recommended Dose: One tablet (80mg Drotaverine + 100mg Aceclofenac) twice daily or as prescribed.

• Administration: Take with meals and a full glass of water.

• Storage: Keep below 30°C, away from direct sunlight and moisture.

Regulatory Documentation & Export Details for Importers/Buyers

Taj Pharma offers complete regulatory and technical support for pharmaceutical importers, distributors, and tenders. Every batch of Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) is backed with internationally recognized documentation and certifications.

Documentation Provided:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certificate

• Free Sale Certificate (FSC)

• Certificate of Analysis (COA)

• Manufacturing License

• Stability Data (Zone II–IV)

• CTD/eCTD Dossier

• Method of Analysis (MOA)

• Batch Manufacturing Record (BMR)

Packaging & Labeling Options:

• 10×10 Blister / Alu-Alu Packs

• Cartons with multilingual labeling (Arabic, French, Spanish, English, etc.)

• Custom branding for private labeling and franchise partners

Shelf Life & Storage:

• Shelf Life: 24–36 months

• Storage Conditions: Below 30°C, dry place, away from sunlight

Certifications:

• WHO-GMP

• EU-GMP equivalent

• ISO 9001:2015

• FDA (India) Approved

• COPP for multiple export markets

Export Markets for Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg)

The demand for Drotaverine + Aceclofenac combination tablets continues to expand across Asia, Africa, CIS, and Latin America, where cost-effective, high-quality pain management products are in demand.

Taj Pharma’s key 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

Taj Pharma’s global distribution network ensures timely delivery and regulatory compliance across all major international markets.

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

1. Advanced Manufacturing Facilities

Taj Pharma operates world-class manufacturing units with:

• Dedicated production lines for solid oral dosage forms

• In-house analytical and microbiological laboratories

• Strict adherence to international pharmacopoeias (IP, BP, USP)

• Robust validation and documentation processes

2. Regulatory Excellence

Taj Pharma’s regulatory team ensures every dossier complies with WHO, EU, and country-specific guidelines—a major advantage for global buyers seeking seamless product registration.

3. Quality Assurance

• 100% quality-tested raw materials

• In-process quality checks

• Finished product analysis before dispatch

• Stability and bioequivalence testing

4. Affordable and Scalable Supply

Taj Pharma delivers competitive pricing for large-volume procurement while maintaining global quality benchmarks. Ideal for:

• Government tenders

• Institutional supply

• Private label distribution

• PCD Pharma partnerships

5. Global Presence

With exports to 80+ countries, Taj Pharma provides end-to-end logistics, technical support, and marketing assistance to partners worldwide.

Technical Product Specification Table

PCD Pharma Franchise Opportunity with Taj Pharma

Taj Pharma offers PCD Pharma Franchise partnerships for Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) across India and international territories.

Benefits include:

• Monopoly marketing rights

• Attractive profit margins

• Marketing and promotional support

• Guaranteed product availability

This opportunity allows distributors to partner with a top-tier pharmaceutical company that delivers both profitability and credibility.

Top 20 FAQs 

1. What is Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) used for?
It treats abdominal pain, cramps, and spasms caused by smooth muscle contractions.

2. Who manufactures this combination in India?
Taj Pharma Ltd, based in Vapi, Gujarat, is a leading WHO-GMP certified manufacturer.

3. How does the combination work?
Drotaverine relaxes muscles, while Aceclofenac reduces inflammation and pain.

4. Is it safe to use during pregnancy?
Consult a doctor before use. It should be taken only if prescribed.

5. Can it cause dizziness?
Yes, mild dizziness may occur; avoid driving immediately after consumption.

6. What is the recommended dose?
Usually, one tablet twice daily with food, as directed by a physician.

7. What certifications does Taj Pharma have?
WHO-GMP, ISO 9001:2015, COPP, CTD-compliant dossiers.

8. Is custom branding available for export?
Yes, private labeling and multilingual packaging are available.

9. What is the shelf life?
Typically 24 to 36 months.

10. What documentation is provided for registration?
CTD Dossier, COPP, COA, Stability data, and Free Sale Certificate.

11. Which countries import from Taj Pharma?
Nigeria, Vietnam, Kenya, Philippines, and over 80 other nations.

12. Is the product available for PCD franchise?
Yes, Taj Pharma offers PCD franchise opportunities PAN India.

13. What are common side effects?
Nausea, dry mouth, dizziness, and mild stomach discomfort.

14. Can it be used for menstrual cramps?
Yes, it is effective for dysmenorrhea (menstrual pain).

15. Is it WHO-GMP certified?
Yes, all batches are manufactured in WHO-GMP compliant facilities.

16. What kind of packaging is available?
Alu-Alu and blister packs in 10×10 configurations.

17. What is the export lead time?
30–45 days, depending on order volume.

18. Does Taj Pharma assist with registration?
Yes, full regulatory and technical support is provided.

19. Is it safe for long-term use?
Short-term use is recommended; consult a physician for long-term treatment.

20. How to contact Taj Pharma for bulk purchase?
Email  info@tajpharma.com or visit www.tajpharma.com.

Call to Action 

If you’re a pharmaceutical importer, distributor, or PCD franchise seeker, looking for a trusted Drotaverine Hydrochloride & Aceclofenac Tablets (80mg+100mg) Manufacturer in India, Taj Pharma Ltd is your perfect global partner.

📍 Head Office: Taj Pharma Ltd, Vapi, Gujarat, India
🌐 Website: www.tajpharma.com
📧 Email: info@tajpharma.com
📞 Phone: +91 74 0000 9975