Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg)

Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg)
Each enteric-coated tablet contains:
Trypsin BP………..……….……48mg
Bromelain ….…………….…….90mg
Rutoside Trihydrate BP..….100mg
Diclofenac Sodium IP……….50mg
Excipients…………………………q.s
Colour: Titanium Dioxide IP
[Total proteolytic activity not less than 1095 FIP units per tablet (Papain method)]

THERAPEUTIC INDICATIONS:

TRYPSIN+BROMELAIN+RUTOSIDE TRIHYDRATE+DICLOFENAC SODIUM is used to relieve pain. It is used in the treatment of pain, swelling, and inflammation associated with osteoarthritis (joint pain, especially in the knees, hip, hands, neck, and lower back) and rheumatoid arthritis (joint pain, especially in the hands and feet).

CAUTION & SCHEDULE:

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

Warning: Taking more than daily dose may cause serious liver damage or allergic reactions (e.g., swelling of the face, mouth and throat, difficulty in breathing, itching or rash).

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.

Dosage: As directed by the Physician.

Introduction: Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets 

Trypsin, Bromelain, Rutoside Trihydrate, and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg) is a powerful anti-inflammatory and pain-relief formulation widely used to manage swelling, muscle pain, and post-surgical inflammation. It combines proteolytic enzymes (Trypsin and Bromelain), an antioxidant (Rutoside Trihydrate), and a non-steroidal anti-inflammatory drug (Diclofenac Sodium) to deliver synergistic action against inflammation, pain, and oxidative damage.

Globally, the demand for this combination therapy has been rising, especially in regions like Latin America, Southeast Asia, Africa, and the Middle East, due to its effectiveness in trauma care, arthritis management, and orthopedic recovery.
As one of the leading WHO-GMP certified manufacturers in India, Taj Pharma stands out as the preferred choice for international buyers, distributors, and PCD franchise partners for Trypsin, Bromelain, Rutoside Trihydrate, and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg).

2. In-depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided:

Taj Pharma ensures that every international shipment of Trypsin, Bromelain, Rutoside Trihydrate, and Diclofenac Sodium Tablets is supported by comprehensive regulatory documentation, including:

• WHO-GMP Certificate

• Certificate of Pharmaceutical Product (COPP)

• Certificate of Analysis (COA)

• Free Sale Certificate

• Stability Data (Zone IV)

• CTD/ACTD Dossiers

• Bioequivalence (BE) Reports (if required)

• FDA/EMA-compliant technical files

These documents meet the import requirements of most global regulatory authorities, including those in Africa, Asia, Latin America, and CIS countries.

Custom Packaging & Labeling:

Taj Pharma offers custom packaging solutions tailored to the client’s branding, market requirements, and language preferences.

• Primary Packaging: Alu-Alu or Blister packs

• Secondary Packaging: Printed cartons with customized labeling

• Bulk Packaging: Export-grade corrugated boxes

All packaging adheres to 21 CFR Part 211 and ISO 9001:2015 quality systems.

Shelf-Life, Storage & Dosage Form:

• Dosage Form: Film-coated tablet

• Strength: 48mg (Trypsin), 90mg (Bromelain), 100mg (Rutoside Trihydrate), 50mg (Diclofenac Sodium)

• Shelf Life: 24–36 months from the manufacturing date

• Storage: Store below 30°C in a dry place, away from sunlight

Export Certifications:

Taj Pharma is recognized for holding prestigious international manufacturing and quality certifications, including:

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

• EU-GMP Certification

• ISO 9001:2015, ISO 14001, and ISO 45001

• COFEPRIS, NAFDAC, INVIMA, and PPB approvals for select countries

These certifications allow Taj Pharma to export confidently to regulated and semi-regulated markets worldwide.

Target Countries & Export Markets:

Taj Pharma exports to 70+ countries, including:
Kenya, Nigeria, Uganda, Myanmar, Vietnam, Cambodia, Sri Lanka, Yemen, UAE, Iraq, Peru, Colombia, Chile, Ecuador, South Africa, Ghana, Nepal, Bangladesh, Philippines, and Russia.

Each shipment undergoes QA/QC batch validation and meets country-specific regulatory and labeling standards.

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

State-of-the-Art Manufacturing Facility – Vapi, Gujarat

Taj Pharma operates a WHO-GMP, ISO-certified facility in Vapi, Gujarat, equipped with advanced technology for granulation, compression, coating, and packaging. The plant complies with ICH Q7 & WHO GMP guidelines, ensuring consistent quality, stability, and safety.

Affordable Pricing & Quality Assurance

Taj Pharma offers competitive pricing for Trypsin, Bromelain, Rutoside Trihydrate, and Diclofenac Sodium Tablets without compromising on global standards.
Each batch undergoes rigorous testing at every stage — from raw material procurement to final product dispatch.

Key quality parameters include:

• Assay and purity

• Dissolution rate

• Uniformity of dosage

• Stability and microbial limits

Global Presence & Supply Chain Strength

With over 20 years of export experience, Taj Pharma maintains a robust international supply chain supported by temperature-controlled logistics, export compliance, and documentation assistance.
Buyers receive prompt dispatch, door-to-door delivery options, and dedicated post-shipment support.

Top 20 Countries Taj Pharma Exports To:

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

4. Technical Product Specification Table

5. Partner with Taj Pharma

If you’re a pharmaceutical distributor, hospital, or importer seeking a trusted WHO-GMP-certified manufacturer for Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg), Taj Pharma is your best choice.

✅ Contact Details:
📍 Taj Pharma India Ltd., Vapi, Gujarat, India
📧 Email:  info@tajpharma.com
🌐 Website: www.tajpharma.com
📞 Call:  +9122-2634 1274

Taj Pharma offers custom export pricing, regulatory support, and fast turnaround for bulk and PCD franchise orders.

6. Top 20 FAQs 

1. What are Trypsin, Bromelain, Rutoside Trihydrate, and Diclofenac Sodium Tablets used for?
They are used for pain, inflammation, and swelling after surgery, trauma, or arthritis.

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

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

4. What are the key ingredients’ roles?
Trypsin & Bromelain (enzymes) reduce swelling, Rutoside (antioxidant) protects tissues, Diclofenac (NSAID) reduces pain.

5. What are the side effects?
Nausea, heartburn, diarrhea, or stomach pain may occur; consult your physician if persistent.

6. Is it safe during pregnancy?
Use only under medical supervision.

7. Can it be taken with food?
Yes, preferably after meals to minimize gastric irritation.

8. What is the storage requirement?
Store below 30°C in a dry and dark place.

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

10. Does Taj Pharma supply globally?
Yes, Taj Pharma exports to over 70 countries.

11. Is WHO-GMP certification mandatory for export?
Yes, for regulated markets, WHO-GMP compliance is essential.

12. Can I get custom packaging?
Yes, multilingual and region-specific packaging is available.

13. What dosage forms are available?
Film-coated tablets (10×10 blister/Alu-Alu).

14. Does Taj Pharma provide CTD dossiers?
Yes, full CTD/ACTD dossiers are available for registration.

15. What conditions benefit from this tablet?
Post-surgical swelling, arthritis, sports injuries, trauma.

16. How does the combination work?
It provides enzymatic anti-inflammatory, antioxidant, and analgesic action.

17. Does Taj Pharma offer third-party manufacturing?
Yes, Taj Pharma provides contract and private label manufacturing services.

18. Are bulk export rates available?
Yes, competitive export pricing is offered.

19. How long has Taj Pharma been in business?
Over 20 years of global pharmaceutical manufacturing and export experience.

20. Why choose Taj Pharma?
Quality, affordability, documentation support, and regulatory compliance make Taj Pharma the #1 manufacturer and exporter in India.

Taj Pharma stands as a global pharmaceutical powerhouse, offering unmatched expertise in the manufacturing and export of Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium Tablets (48mg+90mg+100mg+50mg). Backed by WHO-GMP-certified facilities, stringent quality control, and an extensive export network, Taj Pharma ensures each product meets international standards of excellence.

For buyers, distributors, and importers, partnering with Taj Pharma means assured quality, regulatory reliability, and consistent supply for the global market.