Apremilast tablets

Description

Apremilast Film-Coated Tablets (10 mg / 20 mg / 30 mg)

Healthy Inc is a specialized global supplier and exporter of advanced dermatology, rheumatology, and targeted immunomodulatory therapeutics. We provide ultra-high-purity, kinetically optimized Apremilast Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Small-Molecule PDE4 Inhibitor” is a premium strategic export to dermatology hospitals, psoriasis clinics, and government health ministries, serving as the globally mandated intervention for Moderate-to-Severe Plaque Psoriasis and Psoriatic Arthritis.

Product Overview

This formulation operates as an intracellular “Inflammation Dimmer.” Unlike steroids that broadly suppress the immune system, Apremilast targets the specific chemical messengers inside the cell that trigger skin and joint inflammation.

• Mechanism 1 (PDE4 Inhibition): Apremilast specifically inhibits the enzyme Phosphodiesterase-4 (PDE4). In patients with Psoriasis, PDE4 is overactive, breaking down a natural anti-inflammatory molecule called cAMP (cyclic Adenosine Monophosphate).

• Mechanism 2 (cAMP Elevation): By blocking PDE4, Apremilast causes a surge in intracellular cAMP levels. High levels of cAMP act as a “stop signal” for the production of pro-inflammatory cytokines like TNF-alpha, IL-17, and IL-23.

• Mechanism 3 (The Systemic Balance): By modulating the balance of pro-inflammatory and anti-inflammatory mediators, it reduces the rapid turnover of skin cells (scaling) and the swelling in the joints, providing systemic relief without the need for injections.

Product Composition & Strength

We supply this product in a standardized titration pack format or individual strengths to ensure patient safety during the initial phase.

Technical & Logistics Specifications

• HS Code: 3004.90.99 (Medicaments containing other active substances – Immunomodulator)

• CAS Number: 608141-41-9 (Apremilast)

• Dosage Form: Film-Coated Tablet

• Packaging: Alu-Alu Blisters or Starter Titration Packs. Protects the API from environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

• Small-Molecule Precision: Our manufacturing process focuses on absolute chemical purity to ensure the PDE4 selectivity remains exact, providing the predictable clinical response required for autoimmune patients.

• Titration Pack Mastery: We offer specialized 14-Day Starter Packs (10mg/20mg/30mg combinations) to facilitate the globally recommended “Slow-Start” protocol, enhancing patient adherence and reducing GI drop-outs.

Primary Indications

• Dermatology: Treatment of adult patients with moderate-to-severe Plaque Psoriasis who are candidates for phototherapy or systemic therapy.

• Rheumatology: Treatment of adult patients with active Psoriatic Arthritis.

• Specialist Use: Management of oral ulcers associated with Behçet’s Disease.

Dosage & Administration

• Standard Dosing: Following the initial 5-day titration, the maintenance dose is 30 mg twice daily.

• Administration: Can be taken with or without food. Tablets must be swallowed whole; do not crush or chew.

Safety Warning: Gastrointestinal Tolerability. Common side effects include diarrhea and nausea, especially during the first two weeks. Monitor for Weight Loss and unexplained changes in mood or Depression. Use with caution in patients with severe renal impairment (requires dose reduction).

Global Export & Contract Manufacturing

Healthy Inc is a premier Specialty Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for next-generation Oral Biologic Alternatives. Whether you are a Dermatology Clinic Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.