Letrozole Film-Coated Tablets (2.5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced oncology, endocrinology, and fertility-support therapeutics. We provide ultra-high-purity, kinetically precise Letrozole Film-Coated Tablets (2.5 mg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4/5) oral solid dosage facilities. This “Non-Steroidal Aromatase Inhibitor” is a massive-volume, highly lucrative export to oncology centers, breast cancer specialized clinics, major fertility networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for Hormone Receptor-Positive (HR+) Breast Cancer and the primary pharmacological agent for ovulation induction.
Product Overview
This highly advanced formulation operates as a biochemical “starvation agent” for hormone-dependent tumors. By completely neutralizing the enzyme responsible for estrogen production, it plunges the body’s estrogen levels to near-zero, physically starving the cancer cells of the fuel they need to survive and replicate.
The “Aromatase Blockade & Estrogen Starvation” Specialist:
- Mechanism 1 (The Peripheral Estrogen Eradication): In postmenopausal women, the ovaries have stopped producing estrogen. However, the body continues to produce estrogen in peripheral tissues (fat, muscle, and breast tissue) via an enzyme called aromatase, which converts androgens into estrogens. Letrozole violently and competitively binds to the heme group of the cytochrome P450 subunit of this aromatase enzyme. This total blockade reduces systemic estrogen levels by over 95%, completely halting the growth of estrogen-receptor-positive breast cancer.
- Mechanism 2 (The Postmenopausal Requirement): Letrozole is strictly designed for postmenopausal women (or premenopausal women undergoing chemical ovarian suppression). If given to a woman with active ovaries, the brain senses the massive drop in estrogen and triggers a massive surge of gonadotropins to force the ovaries to produce more, defeating the drug’s purpose in oncology.
- Mechanism 3 (The PCOS & Ovulation Induction Paradox): In the booming global fertility market, Letrozole is used off-label precisely *because* of how the brain reacts. In women with PCOS struggling to conceive, a short 5-day course of Letrozole drops estrogen just enough to trick the pituitary gland into releasing massive amounts of Follicle-Stimulating Hormone (FSH). This forcefully triggers the ovaries to mature and release an egg, making it vastly superior to older drugs like Clomiphene for achieving successful pregnancy without thinning the uterine lining.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the micro-dosed endocrine disruptor.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Letrozole USP/Ph.Eur. | 2.5 mg | Global Oncology & Fertility Standard: The universal therapeutic unit utilized for 5-to-10 year daily adjuvant breast cancer therapy, or short 5-day cyclic dosing for ovulation induction. |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Sodium Starch Glycolate / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Opadry Film | Diluent / Binder / Superdisintegrant / Glidant / Slipper-Coating (Engineered specifically using elite geometric dilution to ensure the microscopic 2.5mg active payload is flawlessly distributed throughout the tablet, guaranteeing absolute content uniformity) |
*Pack Sizes: 10×10 Blisters or Bottles of 30 (Optimized specifically for strict, heavily monitored chronic oncology dispensing or monthly fertility cycles).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Oncology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antineoplastics / Hormone Antagonists) |
| CAS Number | 112809-51-5 (Letrozole) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the delicate micro-dose formulation from environmental humidity across Zone IVb tropical climates and provides a physical barrier against unintended handling by caregivers. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Hormonal Segregation & Micro-Dosing (CRITICAL COMPLIANCE): Letrozole is a highly potent endocrine disruptor. Manufacturing this compound in a standard facility is strictly prohibited due to the risk of cross-contaminating other drugs with anti-estrogen particles. Our production occurs in entirely segregated High-Containment Blocks with dedicated HVAC and HEPA filtration. Furthermore, compounding a 2.5 mg API requires elite multi-stage dry blending to ensure Content Uniformity Relative Standard Deviations (RSD) remain below 3%, guaranteeing absolute clinical precision for cancer patients.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of hormone-dependent malignancies and anovulatory disorders:
- HR+ Early Breast Cancer: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
- Advanced Breast Cancer: First-line treatment of postmenopausal women with hormone receptor-positive or unknown advanced breast cancer.
- PCOS & Ovulation Induction (Off-Label): Utilized globally by fertility specialists as a superior alternative to Clomiphene for inducing ovulation in anovulatory infertility.
Dosage & Administration
Recommended Dosage (Strictly as per Oncologist / Fertility Specialist Guidelines):
- Breast Cancer: 2.5 mg taken orally once daily. Therapy is typically continued for 5 to 10 years or until tumor progression.
- Ovulation Induction: Typically 2.5 mg to 5 mg once daily for 5 days, starting on day 3, 4, or 5 of the menstrual cycle.
- Administration: Can be taken with or without food.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Bone Loss & Severe Osteoporosis: By completely eradicating estrogen (which protects bone density), chronic Letrozole therapy rapidly accelerates bone mineral density loss. Patients face a massively increased risk of severe osteoporosis and catastrophic bone fractures. DEXA bone scans and bisphosphonate co-therapy are highly recommended.
- Severe Arthralgia & Myalgia: Over 30% of patients experience crippling joint pain (arthralgia) and muscle stiffness, which is the leading cause of patients abandoning this life-saving therapy.
- Hypercholesterolemia: Letrozole significantly alters lipid profiles, triggering spikes in LDL cholesterol and increasing cardiovascular risk. Cholesterol monitoring is mandatory.
- Embryo-Fetal Toxicity (Absolute Contraindication): FATAL WARNING: Letrozole can cause severe fetal harm or death. It is strictly contraindicated in women who are or may become pregnant (unless utilized specifically and strictly prior to ovulation in monitored fertility protocols).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Oncology/Fertility Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antineoplastics, Hormonal Antagonists, and High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for breast cancer wards in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.