Description
Ulipristal Acetate Tablets
Healthy Inc is a specialized global supplier and exporter of advanced gynecological, reproductive health, and family planning therapeutics. We provide ultra-high-purity, precision-formulated Ulipristal Acetate Tablets (30 mg / 5 mg), manufactured in WHO–GMP certified, high-capacity oral solid dosage facilities. This “Selective Progesterone Receptor Modulator (SPRM)” is a massive-volume, high-value export to women’s health NGOs, government family planning ministries, retail pharmacy networks, and gynecology clinics in LATAM, the Middle East, Africa, and Southeast Asia, serving as the definitive, globally trusted “120-Hour” emergency contraceptive and targeted therapy for uterine fibroids.
Product Overview
This formulation contains Ulipristal Acetate, a highly advanced, synthetic selective progesterone receptor modulator that provides unprecedented control over the ovulatory cycle.
The “Next-Generation 120-Hour Contraceptive” Specialist:
- Mechanism 1 (The LH Surge Override): The primary mechanism of action for emergency contraception is the delay or inhibition of ovulation. Older drugs (like Levonorgestrel) become completely ineffective once the luteinizing hormone (LH) surge has started (the trigger for the egg to release). Ulipristal Acetate binds to progesterone receptors with such high affinity that it can successfully postpone follicular rupture even during the LH surge, effectively closing the window of vulnerability that older drugs leave open.
- The 5-Day Efficacy Window (30 mg): Because sperm can survive in the female reproductive tract for up to 5 days, an emergency contraceptive must cover this entire window. Ulipristal Acetate maintains a consistently high clinical efficacy rate when taken anywhere up to 120 hours (5 days) after unprotected intercourse or contraceptive failure, making it the supreme global standard for emergency intervention.
- Uterine Fibroid Management (5 mg): At lower, chronic daily doses, Ulipristal acts directly on the progesterone receptors in endometrial and fibroid tissues. It rapidly controls severe uterine bleeding and physically shrinks symptomatic uterine fibroids (myomas) prior to surgical intervention.
Product Composition & Strength
We supply this product as a Film-Coated or Uncoated Tablet, packed in highly secure, moisture-resistant Alu-PVC or opaque Alu-Alu blister strips, optimized for both single-dose retail dispensing and chronic gynecological therapy.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Ulipristal Acetate INN/Ph.Eur. | 30 mg | Emergency Contraception: Single-dose therapy taken within 120 hours of unprotected intercourse. |
| Ulipristal Acetate INN/Ph.Eur. | 5 mg | Uterine Fibroids: Chronic daily dosing for pre-operative management of moderate-to-severe fibroid symptoms. |
| Excipients | Lactose Monohydrate / Povidone / Croscarmellose Sodium | Diluent / Binder / Superdisintegrant (Ensures rapid gastric dispersion for urgent absorption) |
*Pack Sizes: Highly specialized 1×1 Blister in a Retail Mono-Carton (for the 30mg EC market), and standard 10×10 Blisters for the 5mg fibroid management sector.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Family Planning NGOs, and Retail Pharmacy Chains.
| HS Code | 3004.39.00 / 3004.90.99 (Medicaments containing hormones – Contraceptives) |
| CAS Number | 126784-99-4 |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | Alu-PVC or Alu-Alu Blisters. Protects the sensitive hormonal API from hydrolytic degradation in high-humidity (Zone IVb) environments. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light. Keep in original packaging. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Hormonal Containment Compliance: Because Ulipristal Acetate is a potent steroidal modulator, its manufacturing is executed within strictly segregated, highly controlled hormonal/steroid blocks to prevent cross-contamination with other pharmaceutical lines, fully satisfying stringent WHO and national health ministry audits.
- 1×1 Mono-Carton Retail Engineering: For the 30mg Emergency Contraceptive market, we offer advanced, automated blistering that isolates a single tablet into a high-quality, tamper-evident retail mono-carton, perfectly optimized for private pharmacy distribution and high-margin OTC-equivalent sales.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of specialized reproductive health requirements:
- Emergency Contraception (30 mg): Prevention of pregnancy when taken within 120 hours (5 days) after unprotected intercourse or a known/suspected contraceptive failure (e.g., torn condom, missed oral contraceptive pills).
- Uterine Fibroids (5 mg): Pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Dosage & Administration
Recommended Dosage (Strictly as per Gynecologist/Family Planning Guidelines):
- Administration (Emergency Contraception – 30 mg): One 30 mg tablet must be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse. It can be taken with or without food, at any point in the menstrual cycle.
- Vomiting Protocol (CRITICAL): If the patient vomits within 3 hours of taking the 30 mg tablet, another tablet must be taken immediately to ensure systemic absorption.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- NON-ABORTIFACIENT STATUS (Crucial for Import Registration): Ulipristal Acetate is an emergency contraceptive designed to prevent ovulation. It is NOT an abortifacient (like Mifepristone). It will not terminate an existing, implanted pregnancy. This distinction is critical for customs clearance and regulatory approval in conservative markets.
- Existing Pregnancy & Ectopic Risk: Strictly contraindicated if a woman is already known or suspected to be pregnant. Furthermore, if a pregnancy occurs after taking Ulipristal, the physician must urgently evaluate the patient to rule out an ectopic (tubal) pregnancy.
- Hepatic Warning (For the 5mg Chronic Dose Only): Rare but serious cases of drug-induced liver injury, including hepatic failure requiring liver transplantation, have been reported with the chronic daily use of the 5mg fibroid dose. Liver function tests (LFTs) must be performed before, during, and after 5mg treatment. Note: This risk has not been associated with the single 30mg emergency contraceptive dose.
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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gynecological 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 family planning initiatives 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 Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.









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