GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Anidulafungin 100mg
Tartaric Acid USP-NF
(as buffer) 11.2mg
10% w/w Solution of Sodium Hydroxide
USP-NF(pH adjustment) q.s.
10% w/w Solution of Sodium Hydroxide Acid
USP-NF (pH adjustment) q.s.
Excipients q.s.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
SCHEDULE: SCHEDULE H: Not to be sold by retail without the prescription of a Registered medical practitioner.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Anidulafungin for injection 100mg/Vial Technical Specification:
| Product Name: | Anidulafungin for injection 100mg/Vial |
| Brand Name: | (Fungsafe) |
| Strength: | 1mg/vial |
| Dosage Form: | Injection |
| Route of Administration: | Via Oral Route |
| Packing: | 1mg / 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: | Treatment of severe, invasive fungal infections |
| Indication: | is administered as an injection by a healthcare professional. Kindly do not self-administer. Do not skip any doses and finish the full course of treatment even if you feel better. Your liver function should be monitored regularly during treatment. |
| Storage: | Store at 2°C -8°C. Do not freeze . if not used. immediately , the reconstituted solution can be stored at up to 25° C for up to 24 hours. Discard unused portion. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Anidulafungin for injection 100mg/Vial
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Composition : Each vial contains:
Anidulafungin 100mg
Tartaric Acid USP-NF
(as buffer) 11.2mg
10% w/w Solution of Sodium Hydroxide
USP-NF(pH adjustment) q.s.
10% w/w Solution of Sodium Hydroxide Acid
USP-NF (pH adjustment) q.s.
Excipients q.s.
THERAPEUTIC INDICATIONS:
is administered as an injection by a healthcare professional. Kindly do not self-administer. Do not skip any doses and finish the full course of treatment even if you feel better. Your liver function should be monitored regularly during treatment.
CAUTION & WARNING:
CAUTION: should never be given intravenously . store in a cool and dry place.
SCHEDULE: SCHEDULE H: Not to be sold by retail without the prescription of a Registered medical practitioner.
STORAGE & DOSAGE:
Storage: Store at 2°C -8°C. Do not freeze . if not used. immediately , the reconstituted solution can be stored at up to 25° C for up to 24 hours. Discard unused portion.
Dosage: As directed by the Physician.
Anidulafungin for Injection 100mg/Vial Manufacturer in India
The global demand for injectable antifungal medicines continues to grow as healthcare providers require effective treatments for serious fungal infections. Anidulafungin for Injection 100mg/Vial is among the most widely used echinocandin antifungal medicines for treating invasive Candida infections in hospitalized patients.
Taj Medico is an Indian pharmaceutical manufacturer and exporter supplying Anidulafungin for Injection 100mg/Vial to international pharmaceutical distributors, hospitals, government procurement agencies, and institutional buyers. Based in Vapi, Gujarat, India, the company focuses on manufacturing quality pharmaceutical formulations while supporting worldwide export requirements.
Introduction to Anidulafungin for Injection 100mg/Vial
Anidulafungin for Injection 100mg/Vial is a prescription antifungal medicine belonging to the echinocandin class. It works by inhibiting fungal cell wall synthesis, thereby killing fungi responsible for severe systemic infections.
The medicine is primarily prescribed for:
- Candidemia (bloodstream Candida infections)
- Invasive candidiasis
- Intra-abdominal candidiasis
- Esophageal candidiasis
- Serious Candida infections in hospitalized patients
The increasing incidence of fungal infections among immunocompromised patients has significantly increased worldwide demand for Anidulafungin for Injection 100mg/Vial Manufacturer in India.
Medical Information
Anidulafungin for Injection 100mg/Vial is administered only by a qualified healthcare professional.
Patients should never self-administer this medicine.
It is important to:
- Complete the prescribed treatment course
- Avoid skipping doses
- Monitor liver function during therapy when recommended by the treating physician
- Follow medical advice regarding infusion schedules
Common side effects may include:
- Nausea
- Vomiting
- Diarrhea
- Headache
- Fever
- Low blood potassium
- Injection site pain
- Swelling
- Redness
Patients who are pregnant, planning pregnancy, or breastfeeding should consult their healthcare provider before treatment.
Why Global Buyers Source Anidulafungin for Injection 100mg/Vial from India
India has become one of the world’s leading pharmaceutical manufacturing hubs because of:
- Advanced manufacturing technology
- Skilled pharmaceutical professionals
- International quality standards
- Competitive manufacturing costs
- Reliable export logistics
As an experienced Anidulafungin for Injection 100mg/Vial Supplier, Taj Medico supports pharmaceutical importers seeking dependable supply and export documentation.
Export Services for International Buyers
International pharmaceutical buyers often require complete regulatory support in addition to product supply.
Taj Medico assists customers with documentation that may include, where applicable and available:
- Certificate of Pharmaceutical Product (COPP)
- WHO-GMP documentation
- Manufacturing License
- Free Sale Certificate
- Certificate of Analysis (COA)
- Batch Manufacturing Record
- Product Specification Sheet
- Stability Data
- CTD Dossier support
- Shipping Documentation
- Commercial Invoice
- Packing List
- Certificate of Origin
Documentation availability depends on product registration requirements and destination-country regulations.
Custom Packaging and Labeling
Taj Medico offers flexible pharmaceutical packaging solutions for international buyers.
Available options may include:
- Hospital pack
- Institutional pack
- Export packaging
- Private label manufacturing
- Country-specific labeling
- Multi-language artwork
- Barcode printing
- Batch coding
- Serialization support
These services help importers meet local regulatory and branding requirements.
Storage and Shelf Life
Proper storage ensures medicine stability throughout transportation and distribution.
Typical specifications include:
- Dosage Form: Lyophilized Powder for Injection
- Strength: 100mg/Vial
- Route of Administration: Intravenous Infusion
- Storage: Store as directed on the approved product label
- Packaging: Sterile glass vial
- Prescription Status: Prescription-only medicine
Importers should always follow the approved storage conditions specified for the supplied product.
Why Taj Medico is a Trusted Manufacturer and Exporter
Taj Medico has established itself as a pharmaceutical manufacturer and exporter serving international healthcare markets.
Its strengths include:
Modern Manufacturing
Production is carried out using pharmaceutical manufacturing practices designed to support consistent quality.
Quality Assurance
Each batch undergoes quality control testing before release according to applicable specifications.
Competitive Pricing
Efficient manufacturing enables competitive pricing for wholesalers, distributors, and institutional procurement.
Export Support
The export team assists buyers with logistics coordination, documentation, and shipment planning.
Global Supply Chain
Products are supplied through distributors, pharmaceutical importers, hospitals, NGOs, government tenders, and institutional procurement organizations.
Major Export Markets
Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||
Technical Product Specification
| Specification | Details |
|---|---|
| Product Name | Anidulafungin for Injection |
| Strength | 100mg/Vial |
| Dosage Form | Lyophilized Powder for Injection |
| Route | Intravenous Infusion |
| Category | Antifungal |
| Drug Class | Echinocandin |
| Indications | Invasive Candida infections |
| Administration | By healthcare professional only |
| Packaging | Sterile Glass Vial |
| Storage | As per approved labeling |
| Shelf Life | As stated on product label |
| Export Markets | Asia, Africa, Middle East, Latin America |
| Manufacturer | Taj Medico, Vapi, Gujarat, India |
Frequently Asked Questions
1. What is Anidulafungin for Injection 100mg/Vial used for?
It treats serious Candida fungal infections.
2. Can patients self-administer it?
No. It must be administered by trained healthcare professionals.
3. Which class of medicine is it?
It belongs to the echinocandin antifungal class.
4. Is liver monitoring required?
Healthcare providers may recommend liver function monitoring during treatment.
5. What are common side effects?
Nausea, diarrhea, vomiting, headache, fever, and injection-site reactions.
6. Is it effective against invasive candidiasis?
Yes, it is commonly used for invasive Candida infections.
7. Does it require dose adjustment in renal impairment?
Prescribing decisions should follow the approved prescribing information.
8. Is it metabolized by the liver?
Anidulafungin undergoes slow chemical degradation rather than significant hepatic metabolism.
9. Is it suitable for hospitals?
Yes, it is primarily used in hospital settings.
10. Can distributors import it from India?
Subject to local regulatory approvals and import requirements.
11. Does Taj Medico support export documentation?
Documentation support may be available depending on destination-country requirements.
12. Is private labeling available?
Private-label services may be offered for eligible customers.
13. What packaging options are available?
Institutional and export packaging options may be available.
14. What certifications are commonly requested by buyers?
Depending on the product and market, buyers may request documents such as WHO-GMP-related certifications, COPP, or CTD dossiers.
15. Which countries import this product?
Many markets in Asia, Africa, and the Middle East import antifungal medicines, subject to registration.
16. Is bulk supply available?
Bulk supply depends on manufacturing capacity and commercial agreements.
17. Can hospitals purchase directly?
Institutional procurement policies and local regulations determine purchasing arrangements.
18. What is the dosage strength?
100mg per vial.
19. Is prescription required?
Yes.
20. How can international buyers inquire?
Interested buyers can contact Taj Medico’s export team to discuss regulatory requirements, product availability, minimum order quantities, and shipment options.
Contact Taj Medico
If you are a pharmaceutical importer, distributor, institutional buyer, or healthcare procurement organization seeking Anidulafungin for Injection 100mg/Vial Manufacturer in India, Taj Medico welcomes inquiries regarding product availability, export documentation, packaging options, and international supply capabilities. Buyers should ensure compliance with all applicable regulatory and registration requirements in their destination markets.
Mobile: +91 74 0000 9975 / +91 74 0000 9976 (WhatsApp Support)
Email: info@tajpharma.com






