Isotretinoin SoftGel Capsules

Description

Isotretinoin Soft Gelatin Capsules (10 mg / 20 mg)

Healthy Inc is a specialized global supplier and exporter of advanced dermatology, skin health, and retinoid therapeutics. We provide ultra-high-purity, kinetically stable Isotretinoin Softgel Capsules, manufactured in WHO–GMP certified, high-precision softgel manufacturing facilities. This “Systemic Retinoid (Vitamin A Derivative)” is a massive-volume strategic export to dermatology centers, retail pharmacies, and international B2B distributors, serving as the globally preferred intervention for the treatment of severe acne that has not responded to other therapies.

Product Overview

This formulation operates as a “Comprehensive Acne Eradicator.” It is the only medication that physically addresses all four major causes of acne.

• Mechanism 1 (Sebostasis): Isotretinoin physically reduces the size of the Sebaceous Glands by up to 90%. This chemically stops the overproduction of sebum (oil), which is the physical fuel for acne bacteria.

• Mechanism 2 (Follicular Keratinization): It physically prevents the “plugging” of pores by chemically normalizing the shedding of skin cells (keratinocytes), physically preventing the formation of comedones (blackheads/whiteheads).

• Mechanism 3 (Antibacterial/Anti-inflammatory): By drying the skin environment, it physically inhibits the growth of C. acnes bacteria and chemically reduces the deep-seated inflammation and redness associated with cystic acne.

Product Composition & Strength

We supply this product as a Liquid-Fill Softgel, optimized for consistent absorption and gastrointestinal tolerance.

Technical & Logistics Specifications

• HS Code: 3004.90.99 (Medicaments acting on the skin / Others)

• CAS Number: 4759-48-2 (Isotretinoin)

• Dosage Form: Soft Gelatin Capsule (Softgel)

• Packaging: 1 x 10 / 3 x 10 Blister Packs in light-resistant Opaque Foils. Our specialized packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

• Teratogen-Safe Handling: Isotretinoin is a highly sensitive compound. Our manufacturing process utilizes Dedicated Retinoid Suites with HEPA filtration and negative pressure to ensure zero cross-contamination and the highest physical purity.

• Bioavailability Matrix: We utilize Lipid-Based Delivery Systems, physically ensuring that the Isotretinoin is chemically optimized for peak absorption, which is physically critical for the drug’s success.

• Light-Shielded Production: Because Isotretinoin is physically degraded by light, we utilize Amber-Colored Shells and light-protected manufacturing lines to ensure 100% potency at the time of patient consumption.

Primary Indications

• Dermatology: Treatment of Severe Nodular Acne and cystic acne.

• Recalcitrant Cases: Management of acne that has failed to clear with systemic antibiotics and topical treatments.

• Scar Prevention: Early intervention to physically prevent permanent physical scarring and psychological distress.

Dosage & Administration

• Standard Regimen: Typically 0.5 to 1.0 mg/kg/day taken in two divided doses for 15 to 20 weeks.

• Administration: It is physically critical to take the softgel with a high-fat meal to chemically maximize its absorption into the body.

• Cumulative Dose: Treatment is physically aimed at reaching a total cumulative dose (usually 120-150 mg/kg) to ensure long-term remission.

• Lab Monitoring: It is physically critical to monitor Liver Function Tests (LFTs) and Lipid Profiles throughout the treatment course.

Safety Warning: CRITICAL TERATOGENIC RISK. Pregnancy Note: This product physically causes Severe Birth Defects. Female patients must physically use two forms of effective contraception and have regular pregnancy tests. Dryness Note: It physically causes extreme dryness of the lips, skin, and eyes; use of moisturizers and lip balms is mandatory. Contraindication: Do not use during pregnancy, while breastfeeding, or in patients with severe hepatic or renal impairment.

Global Export & Contract Manufacturing

Healthy Inc is a premier Dermatological and Retinoid Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-volume Isotretinoin softgels. Whether you are a National Skin Care Brand in the CIS or a B2B Pharma Marketplace partner in Africa or SE Asia, we ensure secure, WHO-GMP compliant delivery.