Enteric-coated granules | 800 mg sodium aminosalicylate per gram | Anti-tuberculosis medicine
Composition: Each 1 g of enteric-coated granules contains Sodium Aminosalicylate IP 800 mg (80% w/w); Quinoline Yellow Lake, Titanium Dioxide IP and excipients as supplied in the source composition (quantities to be confirmed).
Therapeutic category: Anti-tuberculosis medicine / para-aminosalicylate (PAS).
Dosage form: Enteric-coated granules (not tablets).
SKU: Sodium Aminosalicylate Granules 80%.
Categories: Pharmaceutical Exporter India · Pharmaceutical Formulations India · WHO GMP Certified Formulations
Sodium Aminosalicylate Granules 80% w/w is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Sodium aminosalicylate is a para-aminosalicylate (PAS) medicine used as part of selected combination regimens for drug-resistant tuberculosis when recommended by a TB specialist. The supplied product is an 80% w/w enteric-coated granule formulation: each gram contains 800 mg sodium aminosalicylate IP. Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied product description; certification, export status and facility capabilities should be confirmed against current documents.
| Product | Sodium Aminosalicylate Granules 80% w/w |
|---|---|
| Composition | Each 1 g of granules contains Sodium Aminosalicylate IP 800 mg |
| Strength | 80% w/w (800 mg/g) |
| Dosage form | Enteric-coated / delayed-release granules |
| Other ingredients stated | Quinoline Yellow Lake, Titanium Dioxide IP and excipients (verify approved formulation and permitted colorants in destination market) |
| Therapeutic class | Anti-tuberculosis / para-aminosalicylate |
| Standard | IP listed for active ingredient; finished-product specification to be verified |
| Packaging and shelf life | To be confirmed from registered product label and stability studies; sachet fill weights are not established by the composition |
Enteric coating is intended to protect acid-sensitive material during gastric transit and enable intestinal release. Relevant formulation controls include coating integrity, granule size distribution, uniformity, moisture exposure and stability. Fluid-bed coating and high-barrier sachets are described in the supplied background, but actual equipment, validated process parameters and packaging options require manufacturer confirmation.
Appropriate tests may include identity, assay or content, uniformity, acid resistance, dissolution in suitable buffer, related substances (including aminophenol degradation products), moisture and microbiological quality as required by the approved specification. Do not assume universal numerical limits such as 10% acid-stage release or 80% buffer-stage release without the relevant validated monograph and registered dossier.
Sodium aminosalicylate has antimycobacterial activity and may be included in specialist-selected multidrug regimens for drug-resistant tuberculosis. It must not be used alone to treat TB. Regimen selection depends on susceptibility testing, current national/WHO guidance, tolerability and availability of more effective medicines. Enteric coating is intended to improve formulation performance and gastrointestinal tolerability; it does not eliminate adverse effects.
For institutional and international procurement, request evidence of current manufacturing authorization, applicable GMP certification, country-specific product registration, batch certificates of analysis, stability data, approved artwork and required CTD/ACTD documentation. The availability of COPP, FSC, specific dossiers and FOB/CIF shipping terms should be confirmed with Healthy Life Pharma Pvt. Ltd. / Healthy Inc before making commitments.
Q: What does 80% w/w mean?
A: Each 1 g of granules contains 800 mg of sodium aminosalicylate. This is a mass concentration, not a ready-to-use patient dose.
Q: Are these tablets?
A: No. The supplied product is enteric-coated granules.
Q: Can the granules be chewed?
A: Do not crush or chew enteric-coated granules. Follow the specific approved label for permitted food or drink mixing.
Q: Is this used alone for tuberculosis?
A: No. It is used only as part of a clinician-selected combination regimen.
Dosing must be prescribed by a specialist TB service and calculated using the specific formulation, patient weight, age, renal/hepatic status and the approved local label. The supplied 80% concentration means 1 g of granules provides 0.8 g of sodium aminosalicylate; it does not mean 1 g of granules is equivalent to 1 g of PAS acid. Do not automatically apply dosing instructions from a different PAS formulation or assume that a 4 g sachet contains 4 g active drug. Swallow the enteric-coated granules without chewing; follow the approved instructions for administration with food or acidic liquids.
Adverse effects can include nausea, vomiting, diarrhea, abdominal discomfort and hypersensitivity. Hepatic injury, hypothyroidism and impaired vitamin B12 absorption are clinically relevant concerns. Thyroid and liver monitoring may be required during prolonged therapy. Seek urgent medical assessment for jaundice, severe rash, persistent vomiting or other serious symptoms. Potential interactions and contraindications must be reviewed against the approved product information.
Store in the original sealed, moisture-protective packaging at the temperature specified on the approved label. Avoid excessive heat, humidity and light. Do not use granules from damaged or swollen packaging, or granules with abnormal appearance, until assessed by a pharmacist or supplier. The source mentions storage below 25°C and a 24-month shelf life; both must be checked against product-specific stability and registration records.
For professional and B2B reference. Prescribing information, manufacturing claims, certification and market-specific approvals require verification.