Description
Indinavir Sulphate Capsules
Healthy Inc is a specialized global supplier and exporter of advanced antiretroviral (ARV), infectious disease, and immunological therapeutics. We provide high-purity Indinavir Sulphate Capsules (400 mg), manufactured in WHO–GMP certified, ultra-low humidity oral solid dosage facilities. This “First-Generation HIV Protease Inhibitor” is a targeted export to infectious disease hospitals, NGO epidemic response programs, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a vital component of combination antiretroviral therapy (cART) for the management of HIV-1 infection.
Product Overview
This formulation contains Indinavir Sulphate, a highly specific, synthetic inhibitor of the Human Immunodeficiency Virus (HIV) protease enzyme.
The “Viral Maturation Blocker” Specialist:
- Mechanism (Protease Inhibition): During the late stages of the HIV life cycle, the virus uses its own protease enzyme to cleave large, inactive polyprotein precursors (Gag and Gag-Pol) into the smaller, active structural proteins required to build a new virus. Indinavir physically binds to the active site of this protease enzyme, paralyzing it. As a result, the infected T-cell releases immature, defective viral particles that are completely incapable of infecting other human cells.
- The HAART Backbone: Indinavir is utilized strictly as part of Highly Active Antiretroviral Therapy (HAART). It is co-administered with nucleoside reverse transcriptase inhibitors (NRTIs) to attack the virus at multiple stages of its replication cycle simultaneously, drastically reducing the viral load in the patient’s bloodstream.
- Pharmacokinetic Boosting: In modern protocols, Indinavir is frequently “boosted” by co-administering it with a low dose of Ritonavir (another PI that strongly inhibits liver enzymes). This prevents the rapid breakdown of Indinavir, allowing for lower dosing frequencies and higher, more stable antiviral blood levels.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule, packed strictly in high-density polyethylene (HDPE) bottles containing dedicated desiccant canisters to prevent catastrophic moisture degradation.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Indinavir Sulphate USP/BP | 400 mg (Equivalent to Indinavir Base) | Standard Adult Dose for combination antiretroviral therapy (cART). |
| Excipients | Lactose Monohydrate / Magnesium Stearate | Diluent / Lubricant (Optimized for rapid gastric dissolution) |
*Pack Sizes: HDPE Bottles of 90 or 120 Capsules / High-Barrier Alu-Alu Blisters (Specifically optimized for strict 30-day ARV adherence programs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, NGOs, and HIV Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antiretrovirals) |
| CAS Number | 157810-81-6 |
| Dosage Form | Hard Gelatin Capsule |
| Packaging | HDPE Bottle with Desiccant (CRITICAL). Indinavir is extremely hygroscopic. If exposed to ambient humidity, the capsules will deform and the API will degrade. It must be dispensed and stored in the original container with the desiccant intact. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light and Moisture. Keep bottle tightly closed. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dehumidified Encapsulation Suites: To prevent moisture absorption during the manufacturing phase, the blending and encapsulation of Indinavir are performed under intense environmental controls (Relative Humidity strictly maintained below 35%). This ensures perfect powder flow and long-term stability of the active pharmaceutical ingredient.
- Dissolution Integrity: HIV suppression requires constant, uninterrupted blood levels of the drug. Every batch undergoes rigorous dissolution testing to ensure rapid and total release in the gastric environment, preventing sub-therapeutic dosing that leads to deadly viral resistance.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of retroviral infections:
- HIV-1 Infection: Indicated for the treatment of HIV-1 infection in adults, strictly in combination with other antiretroviral agents (such as Zidovudine, Lamivudine, or Tenofovir).
- Post-Exposure Prophylaxis (PEP): Historically utilized as part of multi-drug regimens for occupational (needlestick) or non-occupational exposure to HIV to prevent seroconversion.
Dosage & Administration
Recommended Dosage (Strictly as per Infectious Disease/ARV Specialist):
- Dietary Restrictions (CRITICAL): When taken unboosted, Indinavir must be taken on an empty stomach (1 hour before or 2 hours after a meal) or with a very light, strictly low-fat meal. Consuming a high-fat or high-calorie meal causes a massive 75% drop in drug absorption, leading to clinical failure.
- Mandatory Hydration Protocol: Patients MUST drink at least 1.5 liters (48 ounces) of liquids over the course of the day to ensure adequate urine output and prevent the crystallization of the drug in the kidneys.
- Strict Adherence: Antiretrovirals must be taken exactly on schedule. Missing doses rapidly breeds drug-resistant HIV strains.
Safety Warnings (CRITICAL):
- Nephrolithiasis/Urolithiasis (Kidney Stones): Up to 20% of patients develop kidney stones caused by the crystallization of Indinavir in the urinary tract. This causes severe flank pain and hematuria (blood in urine). If severe, therapy must be interrupted.
- Hyperbilirubinemia: Indinavir frequently causes indirect hyperbilirubinemia, leading to mild jaundice (yellowing of the skin and eyes) without actual liver damage.
- Metabolic Complications (Lipodystrophy): Like many PIs, prolonged use can cause severe fat redistribution (loss of fat in the face/limbs and accumulation of fat in the abdomen and back of the neck), as well as insulin resistance and severe hyperlipidemia.
- Drug Interactions (CYP3A4): Indinavir is a strong inhibitor of CYP3A4. It is contraindicated with numerous drugs, including statins, sedatives, and ergot alkaloids, due to the risk of fatal toxicities.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Essential Antiretroviral Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for global HIV eradication programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Infectious Disease Wholesaler receives WHO-GMP certified products at competitive rates.











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