Composition: Misoprostol 100 mcg / 200 mcg / 600 mcg
Dosage form: Uncoated tablet
Usage: NSAID-associated gastric ulcer prevention; other uses under specific clinical protocols
Category: Antacid & Anti Ulcer Drugs
Therapeutic category: Prostaglandin E1 analogue / Uterotonic
SKU: Misoprostol Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Misoprostol Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status subject to verification)
Exporter: Healthy Inc (export credentials subject to verification)
Misoprostol is a synthetic prostaglandin E1 analogue used for prevention of NSAID-associated gastric ulcers in selected patients. Under specific approved protocols it is also used in obstetric and gynecologic care, including cervical ripening, management of miscarriage or abortion, and prevention or treatment of postpartum hemorrhage. Approved indications vary by jurisdiction and formulation.
Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied material. Certification, manufacturing site, export status and individual market registrations should be confirmed against current documents.
| Product name | Misoprostol Tablets |
|---|---|
| Confirmed composition labels | Misoprostol 100 mcg; Misoprostol 200 mcg (including IP 200 mcg); Misoprostol 600 mcg |
| Dosage form | Uncoated tablets, per supplied labels |
| Therapeutic class | Prostaglandin E1 analogue; anti-ulcer agent and uterotonic |
| CAS number | 59122-46-2 |
| Usage | NSAID-induced ulcer prevention; obstetric/gynecologic uses only as locally authorized and clinically appropriate |
| Category | Antacid & Anti Ulcer Drugs |
| SKU | Misoprostol Tablets |
| Packaging / shelf life | Verify against approved label and stability studies |
Strength discrepancy: The heading in the supplied material says “200 MG” but its ingredient line says 200 mcg. These units differ by 1,000-fold; the 200 mg heading must be corrected. The description also mentions 25 mcg, but no 25 mcg finished-product composition was provided.
Misoprostol is moisture-sensitive; a validated stable solid formulation and moisture-protective packaging are important. Content uniformity is particularly important for microgram-dose tablets. Specific HPMC dispersion ratios, humidity set points, equipment and exclusive Alu-Alu packaging are not verified by the supplied information.
Quality control should use approved product-specific tests for identification, assay, content uniformity, dissolution/disintegration where applicable, related substances, packaging integrity and stability. No fixed dissolution percentage, assay acceptance range or shelf life can be confirmed without the relevant monograph and registered specification.
Gastrointestinal: Misoprostol reduces gastric acid secretion and helps maintain mucosal protective mechanisms, reducing the risk of NSAID-induced gastric ulcers in selected patients.
Obstetrics and gynecology: It promotes cervical ripening and uterine contractions. Clinical uses and administration routes depend on the indication, gestational age, patient history and local clinical protocols. It is not a contraceptive or birth-control tablet. It may be used in medication abortion regimens, but that is distinct from preventing pregnancy.
Registration and export may require applicable CTD/ACTD documentation, stability data, product specifications, manufacturing authorizations, labeling and certificates of analysis. WHO-GMP certification, COPP, FSC, Star Export House status and availability in specific countries should be verified before commercial publication. Reproductive-health medicines may have additional country-specific restrictions.
Q: Which strengths are supported by the supplied compositions?
A: 100 mcg, 200 mcg and 600 mcg. The 25 mcg strength is mentioned only in descriptive text and requires confirmation.
Q: Is the label “200 mg” correct?
A: No; the matching composition specifies 200 micrograms (mcg), not 200 milligrams (mg). The printed packaging and regulatory artwork must be checked.
Q: Is misoprostol birth control?
A: No. It does not prevent conception.
Q: Can tablets be removed from their blister in advance?
A: Avoid premature removal; follow the approved packaging and storage instructions because exposure to moisture may reduce stability.
Dosage, route (oral, buccal, sublingual or vaginal where supported) and timing vary substantially by indication. Obstetric use requires an appropriate clinical protocol and assessment for contraindications, including previous uterine surgery in relevant settings. Do not substitute a 600 mcg tablet for a 200 mcg tablet without an authorized prescribing instruction. Patients should follow their prescriber and locally approved product information; no universal regimen is suitable for all indications.
Common adverse effects include diarrhea, abdominal cramps, nausea, chills, shivering and fever. Uterine effects can include heavy bleeding and strong contractions; serious complications may occur in certain pregnancy-related circumstances, including uterine rupture in susceptible patients. Seek urgent medical care for severe or persistent bleeding, fainting, severe abdominal pain or signs of infection.
Pregnancy warning: When prescribed for NSAID-ulcer prevention, misoprostol is contraindicated during pregnancy because it can cause pregnancy loss, premature labor or fetal harm. Pregnancy-related use is a distinct, indication-specific medical treatment. Patients should not use it without appropriate clinical guidance.
Protect from moisture and store in the original intact blister or container according to the approved product label. The proposed below-25°C storage limit and 24-month shelf life require product-specific stability confirmation. Keep out of reach of children.