Colistimethate Sodium for Injection I.P. 4.5 MIU

Colistimethate Sodium for Injection I.P. 4.5 MIU Technical Specification:

GENERIC NAME OF MEDICINAL PRODUCT:

1) Colistimethate Sodium for Injection IP 0.5MIU
2) Colistimethate Sodium for Injection IP 1MIU
3) Colistimethate Sodium for Injection IP 2MIU
4) Colistimethate Sodium for Injection IP 3MIU
5) Colistimethate Sodium for Injection IP 4.5MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Each vial contains:
Colistimethate Sodium IP
5,00,000 IU
(IU: International Units)
This Pack Also Contains one FFS Ampoule of 10ml Sterile Water for Injection IP.
As sterile powder for reconstitution
Excipients……………………….q.s.
Water for injection IP 10 ml

2) Each vial contains:
Colistimethate Sodium IP
1,50,000 IU
(1.2 International Units)
The Pack also contains one FFS Ampoule
of 10ml Sterile Water for Injection IP
as sterile powder for reconstitution
Excipients……………………………….q.s.
Water for Injection IP 10 ml.

3) Each vial contains:
Colistimethate Sodium IP
20,00,000 IU
(IU: International Units)
This Pack Also Contains one FFS Ampoule of 10 ml Sterile Water for Injection IP.
As sterile powder for reconstitution
Excipients………………………….. q.s.
For water for injection IP 10 ml.

4) Each vial contains:
Colistimethate Sodium IP
30,00,000 IU
(IU: International Units)
This Pack Also Contains one FFS Ampoule of 10 ml Sterile Water For Injection IP.
As sterile powder for reconstitution
Excipients…………………….. q.s.
Water for Injection IP 10 mL.

5) Each vial contains:
Colistimethate Sodium IP
45,00,000 IU
(IU: International Units)
This Pack Also Contains one FFS Ampoule of 10 ml Sterile Water For Injection IP.
As sterile powder for reconstitution
Excipients……………………………. q.s.
Water for Injection IP 10 ml.

THERAPEUTIC INDICATION:

Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.

CAUTION AND SCHEDULE:

Caution: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

SCHEDULE H PRESCRIPTION DRUG – CAUTION: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light & moisture. Keep all medicines out of reach of children.

DOSAGE: As directed by the physician. Use reconstituted Solution immediately.

Colistimethate Sodium for Injection I.P. 4.5 MIU Manufacturer Supplier in India – Why Taj Medico is the Best Exporter for Global Buyers

Introduction to Colistimethate Sodium for Injection I.P. 4.5 MIU

Colistimethate Sodium for Injection I.P. 4.5 MIU is a sterile injectable antibacterial medicine used in hospital and critical-care settings for selected serious bacterial infections caused by susceptible Gram-negative organisms. Colistimethate sodium is a prodrug of colistin and may have an important role when antimicrobial resistance limits alternative treatment options. Because of its clinical profile, treatment should be determined and supervised by an appropriately qualified healthcare professional.

Taj Medico is an established Colistimethate Sodium for Injection I.P. 4.5 MIU manufacturer in India, supplying pharmaceutical products to domestic and international buyers. Located in Vapi, Gujarat, the company focuses on quality-oriented manufacturing, pharmaceutical supply, documentation, and export support. Reliable access to critical-care antibiotics is increasingly important as healthcare systems address the continuing challenge of antimicrobial resistance.

Understanding Colistimethate Sodium for Injection I.P. 4.5 MIU

Colistimethate sodium is converted in the body to colistin, an antibacterial agent active against certain Gram-negative bacteria. It is generally associated with the management of serious infections where the causative organisms are susceptible and alternative antibacterial options may be inadequate.

The 4.5 MIU presentation provides a specific strength for pharmaceutical and hospital procurement requirements. The appropriate dose, dosing interval, preparation, and treatment duration must be determined by a healthcare professional based on the patient’s condition and relevant clinical factors, including renal function.

For this reason, buyers looking for a dependable Colistimethate Sodium for Injection I.P. 4.5 MIU Supplier should consider product quality, manufacturing controls, regulatory documentation, packaging, storage requirements, and supply reliability rather than focusing exclusively on price.

Global Demand for Critical-Care Antibiotics

Antimicrobial resistance has created an ongoing need for effective medicines used against difficult-to-treat bacterial infections. Hospitals and healthcare procurement organizations therefore require dependable pharmaceutical supply chains capable of maintaining product quality and continuity.

For international buyers, sourcing from an experienced Indian pharmaceutical manufacturer can provide access to established manufacturing capabilities and export infrastructure. Taj Medico supports inquiries from pharmaceutical distributors, importers, institutional buyers, and other authorized healthcare-sector organizations, subject to applicable regulations.

Information for Importers, Exporters and Pharmaceutical Buyers

International procurement involves regulatory, commercial, logistical, and product-specific considerations. Before placing an order, buyers should identify the destination market, required quantity, registration status, packaging requirements, and documentation needed by the importing authority.

Regulatory Documentation

Depending on the country and registration pathway, buyers may require a range of pharmaceutical documents. These can include a Certificate of Analysis, product specifications, manufacturing information, stability documentation, certificates of pharmaceutical product where applicable, and other quality or regulatory records.

For markets using the Common Technical Document framework, appropriate technical information may be organized into relevant CTD sections. Documentation availability should be confirmed for the specific product and destination market rather than assumed.

Custom Packaging and Labeling

International pharmaceutical markets can have different requirements concerning labels, languages, artwork, pack sizes, batch information, manufacturing details, expiry information, storage conditions, and regulatory statements.

Taj Medico can discuss packaging and labeling requirements with prospective buyers according to approved product specifications and destination-market regulations. Any customized packaging should be agreed upon before production and shipment.

Shelf Life, Storage and Dosage Form

Dosage form: Sterile injectable pharmaceutical preparation.

Strength: 4.5 MIU per specified product presentation.

Administration: Parenteral administration under appropriate healthcare supervision.

Shelf life: The exact shelf life should be confirmed from the current approved product specification and packaging.

Storage: Follow the manufacturer’s approved storage instructions and product label.

Preparation, reconstitution, dilution, administration, and dosing should be performed according to the approved product information and the instructions of qualified healthcare professionals.

Export Certifications and Compliance

International pharmaceutical buyers may request documentation relating to WHO-GMP, EU-GMP, COPP, CTD dossiers, manufacturing authorization, stability, quality control, and other regulatory requirements.

Good Manufacturing Practice principles are designed to help ensure that medicinal products are consistently produced and controlled according to appropriate quality standards. Buyers should verify the current certification status of the manufacturing facility and the specific documentation available for the product.

For companies considering Colistimethate Sodium for Injection I.P. 4.5 MIU export from India, the required documentation should be matched to the importing country’s regulatory authority and applicable pharmaceutical legislation.

Target 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 ||

Why Taj Medico is a Preferred Pharmaceutical Supplier

State-of-the-Art Manufacturing Approach

Taj Medico is an established Manufacturer, Exporter and Supplier of Colistimethate Sodium for Injection I.P. 4.5 MIU from Vapi, Gujarat, India. Its manufacturing approach emphasizes controlled processes, quality assurance, testing, documentation, and product consistency.

For sterile injectable medicines, appropriate manufacturing and quality-control systems are essential. Buyers should evaluate the manufacturer’s credentials, product specifications, regulatory documentation, and quality systems before procurement.

Competitive Pricing and Quality Assurance

Competitive pricing is important for pharmaceutical importers and distributors, particularly when purchasing products for institutional or large-scale healthcare supply. Taj Medico aims to provide commercially competitive solutions while maintaining a quality-focused approach.

A comprehensive supplier evaluation should consider product quality, regulatory compliance, documentation, packaging, lead times, logistics, and continuity of supply alongside purchase price.

Global Supply Chain Support

International pharmaceutical exports require careful coordination between manufacturers, exporters, logistics providers, importers, distributors, and regulatory stakeholders. Taj Medico can discuss quantities, packaging preferences, destination requirements, documentation, and shipment arrangements with qualified buyers.

This supply-chain approach helps international customers plan procurement and manage their pharmaceutical sourcing requirements more efficiently.

Colistimethate Sodium for Injection I.P. 4.5 MIU – Technical Specification

Safety and Responsible Use

Colistimethate sodium should be administered only under appropriate medical supervision. The medicine can have significant adverse effects, particularly involving renal and neurological function. Healthcare professionals may therefore monitor kidney function and other relevant clinical parameters during treatment.

Patients should inform their healthcare provider about kidney problems, previous antibiotic allergies, pregnancy, breastfeeding, and other medicines they are taking. The dosage should never be changed independently.

Possible adverse effects can include dizziness, paresthesia, gastrointestinal symptoms, neurological effects, and kidney-related complications. Any severe, unusual, or persistent reaction should be reported promptly to a healthcare professional.

Colistimethate Sodium for Injection I.P. 4.5 MIU PAN India Manufacturer

Taj Medico serves buyers searching for a Colistimethate Sodium for Injection I.P. 4.5 MIU PAN India Manufacturer and pharmaceutical supply partner. Its manufacturing base in Vapi, Gujarat, supports pharmaceutical production and distribution activities.

Domestic buyers, distributors, hospitals, and institutional procurement organizations can communicate their required quantity, delivery location, packaging preferences, and other specifications when making an inquiry.

Colistimethate Sodium for Injection I.P. 4.5 MIU Manufacturer from Mumbai

Searches such as Colistimethate Sodium for Injection I.P. 4.5 MIU Manufacturer from Mumbai may represent buyers looking for pharmaceutical supply in Maharashtra. Taj Medico’s manufacturing location is Vapi, Gujarat, while its products may be supplied to customers across India and international markets, subject to applicable commercial and regulatory conditions.

Buyers should distinguish between a manufacturer, authorized distributor, and trading company when selecting a pharmaceutical supplier.

PCD Pharma Franchise and Distribution Opportunities

Pharmaceutical distributors interested in expanding their critical-care medicine portfolio can discuss potential business opportunities with Taj Medico. Where PCD or franchise arrangements are applicable, commercial terms may depend on territory, licensing, product availability, minimum quantities, marketing arrangements, and regulatory considerations.

A direct discussion with the supplier can help prospective distributors understand product availability and applicable commercial conditions.

Top 20 FAQs

1. What is Colistimethate Sodium for Injection I.P. 4.5 MIU?

It is a sterile injectable antibacterial pharmaceutical product containing colistimethate sodium at a specified strength of 4.5 million international units.

2. What is colistimethate sodium used for?

It may be used for selected serious bacterial infections caused by susceptible Gram-negative organisms under appropriate medical supervision.

3. Is it used for multidrug-resistant bacterial infections?

It may be considered for certain infections involving susceptible multidrug-resistant Gram-negative bacteria when clinically appropriate.

4. What does 4.5 MIU mean?

MIU means million international units. The 4.5 MIU strength corresponds to 4.5 million international units for the specified product presentation.

5. Who should administer this injection?

It should be prepared and administered by an appropriately qualified healthcare professional.

6. Can patients inject it themselves at home?

It should not be self-administered without appropriate professional direction and clinical supervision.

7. Who manufactures Colistimethate Sodium for Injection I.P. 4.5 MIU in India?

Taj Medico is presented as a manufacturer, exporter, and supplier of this product from Vapi, Gujarat, India.

8. Does Taj Medico supply international buyers?

Taj Medico supports pharmaceutical export inquiries, subject to product availability, destination regulations, and applicable documentation.

9. What documents can buyers request?

Depending on the destination market, buyers may request CoA, specifications, stability information, manufacturing documents, COPP, CTD-related information, and other applicable regulatory records.

10. Can packaging and labeling be customized?

Packaging and labeling requirements can be discussed according to the approved product specifications and regulations of the importing market.

11. What is the shelf life?

The current approved product specification and packaging should be consulted for the exact shelf-life period.

12. How should the product be stored?

Storage should follow the manufacturer’s approved labeling and product-specific instructions.

13. Does colistimethate sodium affect kidney function?

Renal toxicity is an important safety consideration, so healthcare professionals may monitor kidney function during therapy.

14. Can neurological reactions occur?

Yes. Neurological adverse reactions can occur, making appropriate clinical monitoring important.

15. Can pregnant patients receive this medicine?

Pregnant or breastfeeding patients should consult their healthcare professional before treatment.

16. Is the product available throughout India?

Supply depends on product availability, distribution arrangements, applicable licenses, and commercial requirements.

17. What is WHO-GMP?

WHO-GMP refers to Good Manufacturing Practice principles associated with pharmaceutical production and quality control.

18. Are WHO-GMP and EU-GMP the same?

No. They are different regulatory frameworks or standards with potentially different certification and inspection requirements. Buyers should verify the specific certification applicable to a facility.

19. Can international buyers purchase bulk quantities?

Importers and distributors can contact Taj Medico to discuss quantities, pricing, packaging, availability, and export requirements.

20. How can buyers request a quotation?

Buyers should provide the required quantity, destination country, preferred packaging, and documentation requirements when contacting Taj Medico for a commercial quotation.

Choosing a Colistimethate Sodium for Injection I.P. 4.5 MIU Manufacturer in India requires careful assessment of manufacturing capabilities, quality systems, regulatory documentation, packaging, supply reliability, and export support. Taj Medico, based in Vapi, Gujarat, India, positions itself as a manufacturer, exporter, and supplier serving domestic and international pharmaceutical buyers.

For companies seeking Colistimethate Sodium for Injection I.P. 4.5 MIU export from India, Taj Medico can discuss product specifications, quantities, packaging, documentation, and commercial requirements. Buyers should provide their destination country and procurement requirements so the appropriate regulatory and supply conditions can be evaluated.