Description
Finasteride Film-Coated Tablets (1 mg / 5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced urology, cosmetic dermatology, and targeted endocrine-modulating therapeutics. We provide ultra-high-purity, kinetically stabilized Finasteride Film-Coated Tablets (1 mg / 5 mg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB) oral solid dosage facilities. This “Type II 5-Alpha Reductase Inhibitor” is a massive-volume, highly lucrative export to urology centers, geriatric care networks, specialized hair-restoration clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for Benign Prostatic Hyperplasia (BPH) and Androgenetic Alopecia (Male Pattern Hair Loss).
Product Overview
This highly advanced formulation operates as a highly specific biochemical blocker. Instead of acting as a broad hormone suppressor, it surgically targets the exact enzyme responsible for converting testosterone into its highly potent, tissue-damaging byproduct, Dihydrotestosterone (DHT).
The “DHT-Blockade & Tissue Regression” Specialist:
- Mechanism 1 (The 5-Alpha Reductase Inhibition): In the prostate gland and the scalp, the enzyme Type II 5-alpha-reductase actively converts circulating testosterone into Dihydrotestosterone (DHT). DHT is the primary androgen responsible for making the prostate grow abnormally large and for choking off hair follicles. Finasteride acts as a potent, competitive, and specific inhibitor of this exact enzyme, violently crashing systemic and tissue DHT levels by up to 70% within days.
- Mechanism 2 (Prostate Shrinkage – 5 mg): In Benign Prostatic Hyperplasia (BPH), an enlarged prostate physically squeezes the urethra, causing agonizing urinary retention and frequent nighttime waking. By cutting off the DHT fuel supply, the 5mg dose forces the hyperplastic prostate tissue to undergo apoptosis (cellular death). Over 6 months of therapy, the prostate physically shrinks in volume, rapidly relieving the mechanical obstruction of the urinary tract and preventing the need for invasive surgery.
- Mechanism 3 (Hair Follicle Rescue – 1 mg): In Androgenetic Alopecia, genetically susceptible hair follicles are highly sensitive to DHT, which causes them to miniaturize and eventually die. The 1mg micro-dose blocks DHT at the scalp level, instantly halting the progression of male pattern baldness and frequently stimulating the robust regrowth of terminal hairs over 3 to 12 months of continuous use.
Product Composition & Strength
We supply this product as a Precision-Blended, Hazard-Shielded 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 highly potent active pharmaceutical ingredient.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Finasteride USP/Ph.Eur. | 1 mg | The Global Dermatology Standard: The definitive micro-dose engineered specifically for the lifelong, daily maintenance of Androgenetic Alopecia (Male Pattern Hair Loss). |
| Finasteride USP/Ph.Eur. | 5 mg | The Global Urology Standard: High-efficacy macro-dose utilized for the aggressive shrinkage of the prostate gland in symptomatic Benign Prostatic Hyperplasia (BPH). |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Sodium Starch Glycolate / Docusate Sodium / Magnesium Stearate / Premium Polymeric Film | Diluent / Binder / Superdisintegrant / Surfactant / Heavy Opadry Film-Coating (Engineered specifically to form an impenetrable physical barrier over the tablet core. This completely seals the teratogenic API, ensuring absolute safety for female pharmacists and caregivers handling the medication) |
*Pack Sizes: 10×10 Blisters or Bottles of 30/100 (Optimized specifically for strict, lifelong chronic urology and dermatology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Urology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Urology/Dermatology) |
| CAS Number | 98319-26-7 (Finasteride) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Ensures the physical integrity of the teratogenic tablet and protects the formulation from degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Teratogenic Containment & Microdose Uniformity (CRITICAL COMPLIANCE): Finasteride is classified as a hazardous, Category X teratogenic compound. Manufacturing this drug in standard generic facilities is strictly prohibited due to the severe risk of aerosolized dust causing birth defects in female factory workers or cross-contaminating other medications. Our production takes place in dedicated, negative-pressure High-Containment Blocks equipped with terminal HEPA filtration. Furthermore, seamlessly blending a 1 mg micro-dose requires elite geometric dilution validated by intensive HPLC batch-testing, guaranteeing absolute clinical uniformity.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of androgen-dependent conditions in adult males:
- Benign Prostatic Hyperplasia (BPH) – 5 mg: Treatment of symptomatic BPH in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for surgery (TURP).
- Androgenetic Alopecia – 1 mg: Treatment of male pattern hair loss (vertex and anterior mid-scalp) in men. (Strictly not indicated for use in women or pediatric patients).
Dosage & Administration
Recommended Dosage (Strictly as per Urologist / Dermatologist Guidelines):
- BPH (5 mg): 5 mg taken orally once daily. Patients must be counseled that while symptom relief may occur early, treatment for at least 6 months is often necessary to assess whether a beneficial response has been achieved.
- Alopecia (1 mg): 1 mg taken orally once daily. Daily use for 3 months or more is necessary before hair growth is observed. Withdrawal of treatment leads to reversal of effect within 12 months.
- Administration: Can be taken with or without meals. Tablets must be swallowed whole and NEVER crushed or broken.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Pregnancy Category X (Absolute Teratogenic Contraindication): FATAL WARNING: Women who are or may potentially be pregnant MUST NOT handle crushed or broken Finasteride tablets. If the active ingredient is absorbed through the skin, it will cause severe abnormalities of the external genitalia of a male fetus.
- The PSA Masking Paradox (Prostate Cancer Risk): Finasteride forcefully shrinks the prostate and drives down Prostate-Specific Antigen (PSA) levels by roughly 50%. When screening a patient for prostate cancer, the physician MUST double the patient’s tested PSA value to get an accurate reading. Failure to do so can mask the presence of high-grade prostate cancer.
- Sexual Dysfunction & PFS: The drug frequently causes decreased libido, erectile dysfunction, and ejaculation disorders. In some cases, these side effects persist long after the drug is discontinued (Post-Finasteride Syndrome).
- Psychiatric Side Effects: Increased risk of severe depression and suicidal ideation has been reported; patients must be monitored for psychiatric changes.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Urology/Dermatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced 5-AR Inhibitors, Teratogenic Compounds, and High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for urology clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.








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