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Description
PRODUCT DESCRIPTION:
Somatropin is a recombinant human growth hormone (rhGH) identical to natural growth hormone produced by the pituitary gland. It plays a crucial role in growth, metabolism, and cellular regeneration. This injectable formulation is used for a wide range of growth hormone deficiencies and related disorders in both pediatric and adult populations.
Our product is developed through advanced recombinant DNA technology, ensuring high purity, bioactivity, and international compliance. It is manufactured in GMP-certified and regulatory-audited facilities, suitable for global distribution under hospital supply, specialty endocrine programs, and biosimilar markets.
Formulation & Presentation:
- Dosage Form: Injections
- Presentation: Vial or pre-filled ampoules (customizable as per market demand)
- Available Strengths: 4 IU, 10 IU, 12 IU, 16 IU, 24 IU
- Route of Administration: Sub-Cutaneous (As per physician’s discretion or therapeutic indication)
Therapeutic Indications:
- Growth Hormone Deficiency (GHD) in children and adults
- Turner Syndrome
- Chronic Renal Insufficiency–related growth failure
- Short stature associated with Noonan Syndrome or Prader-Willi Syndrome
- HIV/AIDS-related muscle wasting
- Small for Gestational Age (SGA) with no catch-up growth
- Adjunct in ART (investigational)
- Off-label uses under physician guidance: Anti-aging, muscle mass enhancement (regulated use only)
Side Effects:
- COMMON: Injection site pain or redness, Edema (fluid retention), Joint pain (arthralgia), Muscle pain, Headache
- SERIOUS (RARE): Intracranial hypertension, Slipped capital femoral epiphysis in pediatric use, Hyperglycemia or insulin resistance, Hypothyroidism, Allergic reactions or anaphylaxis
- PRECAUTIONS:
- Use only under supervision of an endocrinologist or qualified healthcare provider
- Contraindicated in patients with active malignancy
- Monitor blood glucose and thyroid function regularly
- Rotate injection sites to avoid lipodystrophy
- Do not use if hypersensitive to somatropin or any excipients
- Not for use in patients with acute critical illness (e.g., post-surgical complications)
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TECHNICAL INFORMATION
Product Specifications:
- HSN Code: To be assigned per international classification standards
- Weight: Approx. 40g per Carton (With Packaging)
- Dimensions: 15x1x8 CMS
- Shelf Life (Subject To Country Specific Guidelines): Typically 24 to 36 months from date of manufacture or as per label specifications
- Storage: Store below 2°C to 8°C. Protect from moisture and direct sunlight. Do not refrigerate unless specified on the label. Reconstituted solution should be used 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?
- Endocrinology clinics and hormone therapy centers
- Government and hospital procurement departments treating GHD and pediatric growth conditions
- NGOs and humanitarian organizations supporting chronic pediatric care
- Pharmaceutical distributors focusing on biologics and recombinant hormone therapies
- Clinical research organizations and specialty medicine programs
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation support for effective registration support in
- 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 flexibility
- End to End Logistics support flexibility & support
- Deep expertise in exporting specialty injectables & ART products
CONTACT DETAILS:
- E-MAIL: hello@pharmet.io
- Phone/WhatsApp Number: +91 9999091881
- Website: www.pharmet.io
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