Description
Serratiopeptidase Tablets (10mg / 20mg)
Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)
1. Product Introduction
Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Serratiopeptidase Tablets in India. Serratiopeptidase (also known as Serrapeptase) is a powerful Proteolytic Enzyme originally derived from the silkworm. It is widely prescribed as an Anti-Inflammatory and Anti-Edematous agent to reduce pain, swelling, and fluid retention following trauma, surgery, or infection.
We offer Contract Manufacturing (Third Party) services for this sophisticated enzyme formulation. Since Serratiopeptidase is highly sensitive to stomach acid (which destroys its enzymatic activity), we manufacture it exclusively as Enteric Coated Tablets. Our WHO-GMP certified facility in Mumbai utilizes advanced coating technologies to ensure the enzyme survives gastric transit and is absorbed fully in the intestine. Healthy Inc manages the export logistics, supplying orthopedic and dental clinics across Southeast Asia, the Middle East, and Latin America.
2. Product Specifications
| Parameter | Specification |
| Product Name | Serratiopeptidase Tablets |
| Generic Name | Serratiopeptidase Tablets IP / BP |
| CAS Number | 37312-62-2 |
| Strength | 10mg (20,000 Units) / 20mg (40,000 Units) |
| Dosage Form | Enteric Coated Tablet (White / Pink) |
| Standard | IP / BP / USP Compliant |
| Therapeutic Class | Proteolytic Enzyme / Anti-Inflammatory |
| Shelf Life | 24 to 36 Months |
| Packaging | 10×10 Blister / 10×15 Blister / Alu-Alu Pack |
3. Manufacturing Technology
The coating is the most critical factor for efficacy.
The Manufacturer: Healthy Life Pharma Pvt. Ltd.
Enteric Coating: Serratiopeptidase is acid-labile; it denatures rapidly in low pH (stomach acid). We apply a precise Methacrylic Acid Copolymer (Enteric) Coating that remains intact at pH 1.2 (stomach) but dissolves at pH > 6.0 (intestine). This ensures the patient receives the full enzymatic activity.
Activity Retention: Enzymes are sensitive to heat and moisture during processing. We manufacture in Controlled Temperature (< 25°C) and Low Humidity suites to prevent loss of enzymatic potency during granulation and compression.
Purity: We source high-activity API to ensure the tablet remains small and easy to swallow while delivering high therapeutic units.
The Exporter: Healthy Inc
Stability: We recommend Alu-Alu Blisters for tropical climates to provide the best protection against moisture, which triggers enzyme degradation.
4. Quality Assurance
We adhere to strict Pharmacopoeial standards:
Enzymatic Activity (Assay): We do not just measure weight; we measure the Proteolytic Activity (Units) to ensure the enzyme is biologically active.
Disintegration (Enteric Test):
Stage 1 (Acid): No disintegration for 2 hours (stomach simulation).
Stage 2 (Buffer): Complete disintegration within 60 minutes (intestine simulation).
Microbial Limits: Strict controls to ensure the biological origin of the material does not introduce contamination.
5. Why Use Serratiopeptidase?
It is a natural alternative to NSAIDs for swelling.
Mechanism: It breaks down (hydrolyzes) proteins like bradykinin (pain mediator), fibrin, and fibrinogen. It thins the fluids formed at the injury site, promoting drainage and reducing swelling (edema). It also helps break down biofilms in chronic infections.
Key Indications:
Post-Traumatic Swelling: Sports injuries, sprains, and fractures.
Post-Surgical: Reduces swelling after dental surgery (wisdom tooth extraction) or general surgery.
ENT Infections: Sinusitis and laryngitis (thins mucus/sputum).
Breast Engorgement: Reduces pain and swelling in lactating women.
6. Export and Regulatory Support
We streamline the registration process for our B2B partners:
Dossier Support: We offer CTD and ACTD Dossiers for quick registration.
Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.
Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).
7. Frequently Asked Questions
Q: Who manufactures Serratiopeptidase Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using specialized enteric coating technology.
Q: Is it a painkiller?
A: It is not a direct analgesic like Paracetamol. It relieves pain indirectly by reducing the pressure from swelling and breaking down pain-causing proteins.
Q: Can I break the tablet?
A: NO. Breaking or crushing the tablet destroys the enteric coating. The stomach acid will then destroy the enzyme, making the medicine useless. Swallow whole.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION
(For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Dosage: 10mg to 20mg taken 3 times daily.
Administration: Must be taken on an empty stomach (at least 30 mins before food or 2 hours after). If taken with food, the enzyme will digest the food proteins instead of working on the inflammation.
9. Side Effects and Precautions
Common Side Effects: Generally well-tolerated. Occasional nausea, vomiting, or diarrhea.
Bleeding Risk: It acts as a mild blood thinner (fibrinolytic). Stop use 2 weeks before scheduled surgery. Use with caution in patients taking Warfarin or Aspirin.
Skin Reaction: Rare allergic skin rash (Stevens-Johnson syndrome has been reported extremely rarely).
10. Storage Instructions
Store below 25°C in a dry place.
Protect from heat and moisture.
