Cortef hydrocortisone Sodium succinate for injection
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Each vial contains:
Hydrocortisone Sodium
Succinate (Sterile) USP
e.q. to Hydrocortisone 100mg
Hydrocortisone Sodium
Succinate (Sterile) USP
e.q. to Hydrocortisone 100mg
THERAPEUTIC INDICATIONS:
is used to treat certain medical conditions, such as inflammation (swelling), severe allergic reactions, kidney diseases, adrenal problems, arthritis, blood or bone marrow problems, eye or vision problems, lung or breathing problems (eg, asthma), lupus, skin conditions, and ulcerative colitis.
CAUTION & WARNING:
CAUTION: used to treat severe allergic reactions, adrenal crises, acute asthma, shock, and various inflammatory, autoimmune, or rheumatic conditions
Warning: Use only if solution is clear Unused solution should be discarded after three days.
Warning: Use only if solution is clear Unused solution should be discarded after three days.
STORAGE & DOSAGE:
Storage: Store solution at controlled room temperature 20°C to 25°C (68° to 77°F) and protect from light. use solution only if it is clear. Unused solution should be discarded after 3 days.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
hydrocortisone Sodium succinate for injection USP 100mg/vial Technical Specification:
| Product Name: | Cortef hydrocortisone Sodium succinate for injection USP 100mg/vial |
| Brand Name: | (Ladex Cortef) |
| Strength: | 100mg/vial |
| Dosage Form: | injection |
| Route of Administration: | Via Oral Route |
| Packing: | 1 vial |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | anti-inflammatory |
| Indication: | emergency or severe medical conditions requiring fast-acting relief, acute adrenal crisis, severe allergic reactions, and acute flare-ups of inflammatory or autoimmune diseases. |
| Storage: | Store solution at controlled room temperature 20°C to 25°C (68° to 77°F ) and protect from light . use solution only if it is clear . Unused solution should be discarded after 3 days. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Cortef hydrocortisone Sodium succinate for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Each vial contains:
Hydrocortisone Sodium
Succinate (Sterile) USP
e.q. to Hydrocortisone 100mg
THERAPEUTIC INDICATIONS:
is used to treat certain medical conditions, such as inflammation (swelling), severe allergic reactions, kidney diseases, adrenal problems, arthritis, blood or bone marrow problems, eye or vision problems, lung or breathing problems (eg, asthma), lupus, skin conditions, and ulcerative colitis.
CAUTION & WARNING:
CAUTION: used to treat severe allergic reactions, adrenal crises, acute asthma, shock, and various inflammatory, autoimmune, or rheumatic conditions
Warning: Use only if solution is clear Unused solution should be discarded after three days.
STORAGE & DOSAGE:
Storage: Store solution at controlled room temperature 20°C to 25°C (68° to 77°F) and protect from light. use solution only if it is clear. Unused solution should be discarded after 3 days.
Dosage: As directed by the Physician.
Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer in India
When global pharmaceutical buyers seek a trusted Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer in India, Taj Pharma stands among the most respected names in the international pharmaceutical industry. With decades of manufacturing excellence, stringent quality standards, and extensive export capabilities, Taj Pharma delivers premium-quality injectable corticosteroid products to regulated and semi-regulated markets worldwide.
Taj Pharma, the well-known Cortef Hydrocortisone Sodium Succinate for Injection USP manufacturer in India, gives assurance of high quality, purity, efficacy, and compliance with international pharmaceutical standards. The company serves hospitals, government tenders, distributors, importers, institutional buyers, and pharmaceutical companies across multiple continents.
Introduction to Cortef Hydrocortisone Sodium Succinate for Injection USP
What is Cortef Hydrocortisone Sodium Succinate for Injection USP?
Cortef Hydrocortisone Sodium Succinate for Injection USP belongs to the corticosteroid drug class and functions as a glucocorticoid. It is a synthetic version of cortisol, a hormone naturally produced by the adrenal glands. Hydrocortisone sodium succinate is widely used in emergency and critical care settings due to its rapid anti-inflammatory and immunosuppressive action.
The medication is indicated for:
- Adrenal insufficiency
- Severe allergic reactions
- Anaphylaxis
- Asthma exacerbations
- Autoimmune disorders
- Rheumatic diseases
- Dermatologic disorders
- Endocrine disorders
- Shock management
- Severe inflammatory conditions
The global demand for Hydrocortisone Sodium Succinate Injection continues to increase due to rising incidences of autoimmune diseases, allergies, endocrine disorders, and emergency medical requirements.
Taj Pharma is well established Manufacturer, Exporter and Supplier of Cortef Hydrocortisone Sodium Succinate for Injection USP from Vapi, Gujarat, India.
Therapeutic Benefits of Cortef Hydrocortisone Sodium Succinate for Injection USP
Hydrocortisone Sodium Succinate Injection is highly valued because of its fast onset of action and broad therapeutic applications.
Major benefits include:
- Rapid suppression of inflammation
- Effective treatment of adrenal crisis
- Management of severe allergic reactions
- Reduction of immune-mediated tissue damage
- Emergency treatment for shock conditions
- Supportive treatment in critical care settings
Healthcare providers globally depend on hydrocortisone injections for lifesaving interventions and acute care management.
Side Effects and Safety Information
Like all corticosteroid medications, Hydrocortisone Sodium Succinate Injection may produce side effects.
Common side effects include:
- Nausea
- Drowsiness
- Dry mouth
- Insomnia
- Weight gain
- Fluid retention
- Mood changes
- Mild skin irritation
- Burning sensation
- Dryness at injection site
- Stomach upset
Long-term corticosteroid therapy may increase risks of:
- Osteoporosis
- Elevated blood sugar
- Increased infection susceptibility
- Hypertension
- Cataracts
- Adrenal suppression
Patients should always use this medication under medical supervision.
Contraindications
Hydrocortisone Sodium Succinate Injection should not be administered in certain medical conditions.
Contraindications include:
- Systemic fungal infections
- Known hypersensitivity to hydrocortisone
- Hypersensitivity to formulation components
- Certain untreated infections
- Idiopathic thrombocytopenic purpura (for intramuscular administration)
Cortisone injections should also be avoided in patients with:
- Active infections
- Unhealed fractures
- Severe bleeding disorders
Because corticosteroids suppress immune responses, they may delay healing and increase the risk of serious complications.
Why Global Buyers Choose Taj Pharma
Leading Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer in India
Taj Pharma has built a strong reputation as a trusted pharmaceutical exporter and manufacturer serving international markets.
State-of-the-Art Manufacturing Facilities
The manufacturing facilities are equipped with:
- Advanced injectable manufacturing lines
- Modern sterile processing systems
- Automated filling equipment
- High-efficiency HVAC systems
- Cleanroom production environments
- Stringent contamination control procedures
Every batch undergoes extensive testing to ensure compliance with USP and international quality standards.
Quality Assurance Excellence
Taj Pharma maintains rigorous quality assurance procedures including:
- Raw material testing
- In-process quality monitoring
- Finished product analysis
- Stability testing
- Microbiological testing
- Sterility testing
Each product batch is manufactured according to international Good Manufacturing Practices (GMP).
Affordable Pricing
Global importers benefit from:
- Competitive pricing
- Bulk order discounts
- Tender participation support
- Long-term supply agreements
- Cost-effective export solutions
Reliable Global Supply Chain
Taj Pharma ensures:
- Timely shipment execution
- Secure logistics management
- Regulatory compliance support
- Continuous inventory management
- International documentation assistance
Regulatory Documentation for Importers and Distributors
Global pharmaceutical importers require comprehensive regulatory support.
Taj Pharma provides:
Regulatory Documents Available
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Analysis (COA)
- Certificate of Origin (COO)
- Manufacturing License
- Free Sale Certificate
- Product Registration Dossier
- Stability Data
- Validation Reports
- Method of Analysis
- Batch Manufacturing Records
- GMP Certificates
CTD and ACTD Dossier Support
Available documentation includes:
- CTD Dossier
- ACTD Dossier
- eCTD Support
- Bioequivalence Data (where applicable)
- Product Specifications
These documents simplify product registration in international markets.
Custom Packaging and Labeling Solutions
Taj Pharma offers customized packaging services tailored to importer requirements.
Options include:
- Private labeling
- Contract manufacturing
- OEM manufacturing
- Country-specific packaging
- Multilingual labeling
- Customized carton design
- Serialization support
- Tamper-evident packaging
This flexibility allows distributors to market products under their own brand names.
Shelf Life, Storage and Dosage Information
Storage Conditions
- Store below 25°C
- Protect from moisture
- Protect from direct sunlight
- Store in original packaging
Shelf Life
- Typically 24 to 36 months
- Subject to stability data approval
Dosage Form
- Sterile Injectable Powder
- Lyophilized Injection
- Intravenous Administration
- Intramuscular Administration
Dosage should always be determined by qualified healthcare professionals.
Export Certifications Available
Taj Pharma supports international pharmaceutical registration with globally accepted certifications.
Certifications
- WHO-GMP
- EU-GMP (where applicable)
- COPP
- ISO Certification
- GLP Compliance
- CTD Dossier
- ACTD Dossier
- Product Registration Support
These certifications make Taj Pharma a preferred WHO-GMP Manufacturer India for global pharmaceutical procurement.
Target Export Markets
Taj Pharma exports pharmaceutical products to regulated and semi-regulated markets worldwide.
Major Export Regions
Africa
- Nigeria
- Ghana
- Kenya
- Uganda
- Tanzania
- Ethiopia
- South Africa
Asia
- Philippines
- Vietnam
- Myanmar
- Cambodia
- Sri Lanka
- Nepal
CIS Countries
- Kazakhstan
- Uzbekistan
- Kyrgyzstan
- Armenia
- Azerbaijan
Middle East
- UAE
- Saudi Arabia
- Oman
- Qatar
- Yemen
Latin America
- Peru
- Bolivia
- Guatemala
- Honduras
- Ecuador
Top 20 Countries Exporting Support by Taj Pharma
Taj Pharma actively supplies and supports registration requirements in:
🌍 Nigeria 🌍 Kenya 🌍 South Africa 🌍 UAE 🌍 Saudi Arabia 🌍 Oman 🌍 Vietnam 🌍 Philippines 🌍 Myanmar 🌍 Peru 🌍 Chile 🌍 Bolivia 🌍 Egypt 🌍 Ethiopia 🌍 Tanzania 🌍 Indonesia 🌍 Malaysia 🌍 Colombia 🌍 Ecuador 🌍 Thailand
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Product Name | Cortef Hydrocortisone Sodium Succinate for Injection USP |
| Generic Name | Hydrocortisone Sodium Succinate |
| Therapeutic Class | Corticosteroid |
| Pharmacological Class | Glucocorticoid |
| Dosage Form | Injection |
| Route of Administration | IV / IM |
| Pharmacopoeia | USP |
| Strength | As per buyer requirement |
| Packaging | Vial |
| Shelf Life | 24–36 Months |
| Storage Condition | Below 25°C |
| Regulatory Documents | COA, COPP, CTD, FSC |
| Manufacturing Standard | WHO-GMP |
| Origin | India |
| Manufacturer | Taj Pharma |
Cortef Hydrocortisone Sodium Succinate for Injection USP PAN India Manufacturer
Taj Pharma has established itself as a premier:
- Cortef Hydrocortisone Sodium Succinate for Injection USP PAN India Manufacturer
- Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer Supplier and PCD Pharma Franchise
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- Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer from Mumbai
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- Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer in Mumbai
- Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer Vapi Gujarat
- Leading #1 Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer & Supplier in India
- Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturers Exporters India
Top 20 FAQs
1. What is Hydrocortisone Sodium Succinate Injection used for?
It treats severe inflammation, allergies, adrenal insufficiency, and emergency conditions.
2. Is it a corticosteroid?
Yes, it belongs to the glucocorticoid corticosteroid class.
3. Who manufactures it in India?
Taj Pharma is a leading manufacturer and exporter.
4. Is WHO-GMP certification available?
Yes, Taj Pharma provides WHO-GMP compliant manufacturing.
5. Can distributors obtain private labeling?
Yes, OEM and private labeling services are available.
6. Is CTD dossier support available?
Yes, complete CTD dossier support is provided.
7. What is the shelf life?
Generally 24–36 months.
8. What packaging options are available?
Custom vial and export packaging options are available.
9. Can it be exported globally?
Yes, subject to local regulatory approvals.
10. Is COPP available?
Yes, upon request.
11. Is the product sterile?
Yes, it is manufactured under sterile conditions.
12. Is registration support provided?
Yes, complete regulatory assistance is available.
13. What are common side effects?
Nausea, insomnia, weight gain, and fluid retention.
14. Is it suitable for emergency use?
Yes, it is commonly used in emergency medicine.
15. Can hospitals purchase directly?
Yes, institutional procurement is supported.
16. Are bulk orders accepted?
Yes, large commercial orders are welcomed.
17. What export documents are supplied?
COA, COO, COPP, FSC, and GMP certificates.
18. Can country-specific labels be printed?
Yes, customized labeling is available.
19. What markets does Taj Pharma serve?
Africa, Asia, CIS, Middle East, and Latin America.
20. Why choose Taj Pharma?
Quality assurance, regulatory support, competitive pricing, and global export expertise.
Contact Taj Pharma
If you are searching for a trusted Cortef Hydrocortisone Sodium Succinate for Injection USP Manufacturer in India, Taj Pharma offers comprehensive manufacturing, export, private labeling, contract manufacturing, registration support, and global distribution services.
Whether you are an importer, distributor, government procurement agency, hospital chain, or pharmaceutical company, Taj Pharma provides reliable supply solutions backed by WHO-GMP quality standards, competitive pricing, and international regulatory support.
