Description
Carbimazole Tablets (5mg / 10mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Carbimazole Tablets in India. This antithyroid agent is a first-line treatment for Hyperthyroidism (overactive thyroid) and Graves’ Disease. We produce high-purity tablets that ensure precise regulation of thyroid hormone production. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and endocrinology tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Carbimazole Tablets | | Generic Name | Carbimazole BP / IP | | Strength | 5mg / 10mg / 20mg | | Dosage Form | Uncoated / Film Coated Tablet | | Standard | BP / IP / USP Compliant | | Therapeutic Class | Antithyroid Agent (Thionamide) | | Shelf Life | 24 – 36 Months | | Packaging | 10×10 Blister / 100s HDPE Bottle |
3. Manufacturing Carbimazole Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Carbimazole is sensitive to moisture; if exposed to humidity during production, it can degrade prematurely into Methimazole. To prevent this, we manufacture in Dehumidified Suites and use moisture-protective excipients. This ensures the patient receives the full therapeutic dose in its correct pro-drug form for optimal absorption and conversion.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Carbimazole Tablets. We supply endocrinology clinics and pharmacy chains globally, particularly in Commonwealth regions where Carbimazole is the preferred standard of care over Methimazole.
4. Quality Assurance We test every batch rigorously.
Assay: We confirm the precise dosage (5mg/10mg). Accurate dosing is critical because slight variations can lead to hypothyroidism (underactive thyroid).
Related Substances: We monitor for impurities to ensure the drug is pure and safe for long-term use (12-18 months).
Dissolution: We ensure consistent release profiles to maintain stable thyroid hormone levels throughout the day.
5. Why Use Carbimazole Tablets? This drug stops the thyroid from making too much hormone.
Mechanism: Carbimazole is a pro-drug. After absorption, it is converted into the active form, Methimazole. Methimazole inhibits the enzyme thyroid peroxidase, which is needed to attach iodine to tyrosine residues.
Effect: It prevents the synthesis of thyroid hormones (T3 and T4), gradually bringing the patient back to a “Euthyroid” (normal) state.
Key Indications:
Hyperthyroidism: Reduction of high thyroid hormone levels.
Graves’ Disease: Autoimmune overactivity of the thyroid.
Pre-operative Preparation: Used to stabilize thyroid levels before a thyroidectomy (surgery).
Radioiodine Therapy: Used before and after radioactive iodine treatment.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Carbimazole Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this the same as Methimazole? A: Carbimazole is the pro-drug of Methimazole. 10mg of Carbimazole converts to approximately 6mg of Methimazole in the body.
Q: Can you supply the 20mg strength? A: Yes, we can manufacture higher strengths for severe cases or initial loading doses.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Starting Dose: Usually 15mg to 40mg daily, divided into doses, until the patient becomes euthyroid (usually 4-8 weeks).
Maintenance Dose: reduced to 5mg to 15mg daily.
Administration: Swallow whole with water. Can be taken with or without food.
9. Side Effects and Precautions
Agranulocytosis: A rare but serious drop in white blood cells. Patients must report sore throat, fever, or mouth ulcers immediately.
Liver Function: Can cause liver issues (cholestatic jaundice).
Pregnancy: Methimazole/Carbimazole can cross the placenta. Propylthiouracil (PTU) is often preferred in the first trimester, but Carbimazole may be used later if necessary.
10. Storage Instructions
Store below 25°C in a dry place.
Moisture Sensitive: Keep the container tightly closed.
Keep out of reach of children.
