SSRI Antidepressant | Film-coated tablets | Pharmaceutical supply enquiries
Simvastatin Tablets USP 20 mg: Each film-coated tablet contains Simvastatin USP 20 mg.
Simvastatin Tablets USP 40 mg: Each film-coated tablet contains Simvastatin USP 40 mg.
Usage: Lowering elevated cholesterol and reducing cardiovascular risk in appropriately selected patients.
Therapeutic category: Antilipidemic / HMG-CoA reductase inhibitor (statin).
SKU: Simvastatin Tablets
Categories: Pharmaceutical Exporter India · Pharmaceutical Formulations India · WHO GMP Certified Formulations
Simvastatin Tablets USP is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.
Simvastatin is an HMG-CoA reductase inhibitor (statin) prescribed to reduce elevated LDL cholesterol and, for selected patients, the risk of cardiovascular events. The supplied formulations are Simvastatin Tablets USP 20 mg and 40 mg, both film-coated. Healthy Life Pharma Pvt. Ltd. is named as manufacturer and Healthy Inc as exporter in the supplied product information. Verify certifications and market-specific registrations before publication.
| Product | Simvastatin Tablets |
|---|---|
| Active ingredient | Simvastatin USP |
| Confirmed strengths | 20 mg / 40 mg |
| Dosage form | Film-coated tablets |
| Standard | USP (as supplied) |
| CAS number | 79902-63-9 |
| Therapeutic class | Antilipidemic / Cardiovascular Agent / Statin |
| SKU | Simvastatin Tablets |
| Other strengths | 5 mg, 10 mg and 80 mg mentioned in background information; not confirmed as supplied products. The 80 mg dose is subject to major safety restrictions. |
| Packaging / shelf life | Confirm from approved product specifications and stability data |
Manufacturing considerations include controlling oxidation and moisture exposure, validating the active ingredient and excipients, achieving dosage-unit uniformity, and establishing appropriate film-coating and packaging protection. Simvastatin is a lactone prodrug; formulation stability and impurity formation should be assessed. Specific antioxidants, granulation techniques and coating brands must be supported by actual manufacturing records.
Quality testing should follow the applicable USP monograph and approved registration specifications, including identity, assay, dissolution, uniformity of dosage units, related substances and stability. Numeric acceptance limits and shelf life should be taken from validated methods and approved batch specifications rather than assumed.
Simvastatin reduces hepatic cholesterol synthesis by inhibiting HMG-CoA reductase and increases clearance of circulating LDL cholesterol. It may be used for primary hyperlipidemia and cardiovascular risk reduction when clinically indicated. Treatment is generally combined with dietary and lifestyle measures. It is not a treatment for an acute heart attack or stroke.
For B2B procurement and export enquiries, confirm destination-country marketing authorisation, product registration, current GMP documentation, certificate of analysis, approved labelling, dossier availability, and shipping terms directly with the manufacturer or exporter. CTD/ACTD, COPP, FSC and other certificates should only be promised when actually available for the relevant product and market.
Q: What strengths are confirmed?
A: The supplied compositions specify USP 20 mg and USP 40 mg film-coated tablets.
Q: Why is simvastatin commonly taken in the evening?
A: Because simvastatin is relatively short-acting and cholesterol synthesis is higher overnight, once-daily evening administration is commonly recommended; follow the prescribed label.
Q: Can grapefruit be consumed?
A: Grapefruit products can increase simvastatin exposure and muscle-toxicity risk and should generally be avoided.
Simvastatin is commonly prescribed once daily in the evening; dose selection and adjustment depend on cholesterol goals, comorbidities, interactions and local prescribing information. The supplied product strengths are 20 mg and 40 mg. The 80 mg dose is restricted because of increased myopathy risk and must not be presented as a routine dose. Patients should not change their dose without medical advice.
Potential adverse effects include muscle aches, gastrointestinal symptoms, headache and liver-enzyme elevations. Rare but serious muscle injury (myopathy or rhabdomyolysis) requires urgent evaluation, particularly with marked muscle pain, weakness or dark urine. Important interactions include strong CYP3A4 inhibitors and certain cardiovascular medicines; dose restrictions may apply. Simvastatin should generally be discontinued during pregnancy, with decisions individualized by a clinician; breastfeeding while taking simvastatin is not recommended. Check liver disease, interacting medicines and grapefruit intake.
Store according to the approved product label, protected from excessive heat and moisture and out of reach of children. A specific temperature limit and expiry period must be confirmed against the registered packaging and stability documentation.
For professional and B2B reference. Prescribing information, manufacturing claims, certification and market-specific approvals require verification.