Hydroxyprogesterone Injection 250 MG/ML
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Hydroxyprogesterone Injection 250 MG/ML

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Description

PRODUCT DESCRIPTION:

 

Hydroxyprogesterone is a long-acting synthetic progestin used to reduce the risk of preterm birth in women with a history of spontaneous preterm deliveries.

It also plays a role in selected gynecological and endocrine disorders, including amenorrhea and abnormal uterine bleeding.

The 250 MG/ML intramuscular formulation provides sustained progestational effect, ensuring consistent hormonal support over a prolonged period.

Manufactured in GMP-compliant facilities, the product offers both efficacy and safety for use in obstetric and gynecological settings.

Formulation & Presentation:

  • Dosage Form: Injectable Solution
  • Presentation: Sterile, single-use ampoule or vial (customizable as per market demand)
  • Available Strengths: 250 MG/ML
  • Route of Administration: Intramuscular Only (IM) or as per clinical indication and severity (As per physician’s discretion or decision)

Therapeutic Indications:

  • Prevention of recurrent preterm birth in women with prior spontaneous preterm delivery
  • Treatment of secondary amenorrhea
  • Management of dysfunctional uterine bleeding due to hormonal imbalance
  • Adjunct in hormone replacement therapy protocols (as clinically indicated)

Side Effects:

  • COMMON:
    • Pain or swelling at injection site
    • Headache or dizziness
    • Breast tenderness
    • Mild nausea
  • SERIOUS (RARE):
    • Allergic reactions
    • Thromboembolic events
    • Jaundice or hepatic dysfunction
    • Depression or mood alterations
  • PRECAUTIONS:
    • Contraindicated in known or suspected cases of breast, liver, or hormone-sensitive cancers
    • Use with caution in patients with a history of thromboembolic disorders
    • Periodic liver function monitoring is advised during prolonged therapy
    • Should be administered under strict medical supervision, especially in obstetric settings

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TECHNICAL INFORMATION

Product Specifications:

  • HSN Code: To be assigned per international classification standards & import jurisdiction
  • Weight: Approx. 40g per Carton (With Packaging)
  • Dimensions: (15x1x8 CMS)
  • Shelf Life (Subject To Country Specific Guidelines): 2 to 3 years under recommended storage conditions from date of manufacture or as per label specifications
  • Storage: Oil-based injectable solution requiring cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. The solution should be used strictly as per label guidelines.

Regulatory Status & Supply Information:

  • Regulatory Status: WHO-GMP Complaint Manufacturing. Further certifications available on request
  • Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
  • Stability: Compliant
  • MOQ: Negotiable. Based on market & registration status
  • Export Options: Available for private label, institutional supply, or branded export

Who Should Source This Product?

  • Hydroxyprogesterone Injection 250 MG/ML is suitable for obstetric and gynecological hospitals, maternal health programs, fertility centers, government healthcare procurement agencies, and NGOs working in women’s health.
  • It is especially relevant in regions across Africa, Latin America, Southeast Asia, and Middle East where reducing preterm birth is a public health priority.

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation support for effective registration
  • Trusted consortium network, simplifying India’s complex pharma supply chain
  • Multiple approved manufacturers for best fit in import country
  • Network of audited, compliant manufacturers across India
  • Customizable & flexible branding, packaging & formulation options
  • End-to-end logistics flexibility & support
  • Deep expertise in exporting specialty injectables & all products

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