Colistimethate Sodium for Injection I.P. 0.5 MIU

Colistimethate Sodium for Injection I.P. 0.5 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.

Introduction to Colistimethate Sodium for Injection I.P. 0.5 MIU

Colistimethate Sodium for Injection I.P. 0.5 MIU is a critical-care antibacterial medicine belonging to the polymyxin group. It is used under professional medical supervision for serious infections caused by susceptible Gram-negative bacteria, particularly situations in which multidrug-resistant organisms may limit treatment options. Because such infections can occur in critically ill hospitalized patients, dependable access to appropriately manufactured injectable antibiotics is important for healthcare systems and pharmaceutical procurement organizations.

As a Colistimethate Sodium for Injection I.P. 0.5 MIU manufacturer in India, Taj Medico focuses on quality-oriented pharmaceutical manufacturing and international supply. Its manufacturing operations are located in the Vapi-Sarigam pharmaceutical industrial zone of Gujarat, an established Indian pharmaceutical manufacturing cluster. Taj Medico states that its facility is WHO-GMP certified and supports international pharmaceutical manufacturing requirements.

Colistimethate sodium is generally administered by a healthcare professional. Dose selection and treatment duration depend on the infection, patient characteristics, renal function, and applicable prescribing information. It should not be self-administered or used without appropriate medical supervision.

Colistimethate Sodium for Injection I.P. 0.5 MIU Manufacturer in India

Taj Medico is an established Manufacturer, Exporter and Supplier of Colistimethate Sodium for Injection I.P. 0.5 MIU from Vapi, Gujarat, India, supporting pharmaceutical distributors, importers, institutional buyers, hospitals, wholesalers, and international healthcare businesses.

For global buyers, sourcing an injectable antibiotic involves more than obtaining a competitive quotation. Buyers generally require consistent product specifications, appropriate packaging, batch documentation, regulatory support, secure logistics, and dependable communication. Taj Medico positions its manufacturing and export services around these requirements.

The company’s website highlights manufacturing infrastructure in the Vapi-Sarigam region, quality-control systems, regulatory affairs support, contract manufacturing, private labeling, and pharmaceutical export capabilities.

Product Information for Global Pharmaceutical Buyers

Colistimethate Sodium for Injection I.P. 0.5 MIU is a sterile injectable dosage form intended for administration by qualified healthcare professionals. The product is relevant to hospital and institutional procurement because injectable antimicrobial medicines may be required for patients who need parenteral therapy.

The exact dosage regimen, reconstitution instructions, administration route, contraindications, warnings, and storage conditions should always follow the approved product label, applicable pharmacopoeial requirements, and the destination country’s regulatory authorization. Kidney function is particularly important when colistimethate sodium is used because dosing and monitoring may require adjustment in patients with renal impairment.

Commonly reported adverse effects can include neurological symptoms such as dizziness, paresthesia or weakness and gastrointestinal symptoms. Clinically significant reactions require medical assessment. Buyers should therefore ensure that product labeling and technical documentation correspond to the requirements of the intended market.

Regulatory Documentation for Importers, Exporters and Buyers

For international pharmaceutical procurement, regulatory documentation is a major part of supplier evaluation. Depending on the destination country, product registration status, and commercial arrangement, documentation may include a Certificate of Analysis (CoA), Certificate of Pharmaceutical Product (COPP) where applicable, manufacturing and GMP documentation, product specifications, stability information, batch records or summaries, packaging details, and other technical documents required by the importing authority.

Taj Medico also highlights regulatory affairs and documentation support for international markets. Buyers should request the exact document package required for their country before placing a commercial order.

WHO explains that GMP is designed to ensure medicines are consistently produced and controlled according to appropriate quality standards, covering production, quality control, documentation, premises, personnel, materials, and related processes.

Custom Packaging, Labeling and Export Support

International pharmaceutical buyers may require customized secondary packaging, artwork, language-specific labeling, shipping marks, batch identification, country-specific information, and private-label presentation. Packaging requirements should be agreed before production so that the finished product complies with the destination market.

For Colistimethate Sodium for Injection I.P. 0.5 MIU export from India, Taj Medico can coordinate packaging and documentation requirements according to the commercial and regulatory needs agreed with authorized buyers. Exact customization options, minimum order quantities, artwork requirements, and regulatory documents should be confirmed during quotation and order processing.

Shelf Life, Storage and Dosage Form

Colistimethate Sodium for Injection I.P. 0.5 MIU is supplied as a sterile injectable pharmaceutical preparation. The exact shelf life and storage conditions should be taken from the approved product specification and market-specific packaging because requirements can vary by formulation, packaging configuration, and regulatory approval.

Healthcare professionals should follow the product label for storage, preparation, reconstitution, administration, and handling. Export buyers should request current stability and product-storage documentation before finalizing procurement.

WHO-GMP, EU-GMP, COPP and CTD Dossier Support

For pharmaceutical exports, compliance documentation can significantly influence market access. Taj Medico states that its manufacturing facility is WHO-GMP certified and that it is working toward PIC/S and EU-GMP approvals. Therefore, buyers should verify the current status and applicability of each certification for the specific facility and product before using such credentials in regulatory submissions.

Depending on the destination market, buyers may also require a CTD dossier, COPP, manufacturing authorization documents, CoA, product specifications, stability data, analytical methods, and other regulatory documents. Availability depends on the product, market, and registration pathway.

Why Taj Medico is a Trusted Supplier and Exporter

Taj Medico combines pharmaceutical manufacturing infrastructure, quality-focused production, regulatory support, and export coordination from its Vapi, Gujarat operations. Its website describes a state-of-the-art facility in the Sarigam GIDC industrial area and emphasizes WHO-GMP manufacturing, quality assurance, regulatory affairs, third-party manufacturing, private labeling, and global pharmaceutical exports.

For buyers searching for a Colistimethate Sodium for Injection I.P. 0.5 MIU Supplier, the major advantages include professional sourcing support, competitive commercial discussions, documentation assistance, packaging coordination, and supply-chain management. Taj Medico can also support pharmaceutical businesses seeking manufacturing partnerships rather than simple product purchasing.

Affordable Pricing and Quality Assurance

Competitive pricing is important for distributors and institutional buyers, but injectable medicines require quality to remain the primary consideration. Taj Medico emphasizes quality, affordability, and consistent manufacturing as part of its pharmaceutical business model.

WHO notes that GMP helps reduce risks such as contamination, mix-ups, incorrect labeling, and inconsistent product quality. This makes quality-system compliance an important consideration when selecting a WHO-GMP manufacturer in India.

Top 20 Countries and Regions for Pharmaceutical Export Opportunities

Taj Medico’s international business model can support buyers across emerging and established pharmaceutical markets, subject to applicable registration and import requirements. Potential target markets include Saudi Arabia, United Arab Emirates, Oman, Bahrain, Iraq, Jordan, Nigeria, Tanzania, Kenya, Uganda, Ghana, Zambia, South Africa, Ethiopia, Egypt, Indonesia, Malaysia, Philippines, Vietnam, and Sri Lanka.

Actual product availability, registration, labeling, import authorization, and commercial supply should always be verified for each individual country.

Technical Product Specification

Colistimethate Sodium for Injection I.P. 0.5 MIU PAN India Manufacturer

For pharmaceutical businesses searching for Colistimethate Sodium for Injection I.P. 0.5 MIU PAN India Manufacturer, Taj Medico offers a Vapi-based manufacturing and supply platform capable of supporting buyers beyond a single regional market. The company can work with distributors, hospitals, institutional procurement teams, pharmaceutical companies, wholesalers, and authorized importers.

Related sourcing terms include Colistimethate Sodium for Injection I.P. 0.5 MIU Manufacturers PAN India Suppliers Exporters, Colistimethate Sodium for Injection I.P. 0.5 MIU Manufacturer & Supplier, and Colistimethate Sodium for Injection I.P. 0.5 MIU Manufacturer Vapi, Gujarat.

Colistimethate Sodium for Injection I.P. 0.5 MIU Manufacturer from Mumbai and India

Buyers searching for Colistimethate Sodium for Injection I.P. 0.5 MIU Manufacturer from Mumbai, Colistimethate Sodium for Injection I.P. 0.5 MIU in Mumbai, Maharashtra, or a nationwide supplier can consider manufacturers operating from established pharmaceutical hubs such as Gujarat. Taj Medico’s Vapi location provides access to established pharmaceutical infrastructure and export logistics.

For buyers comparing Colistimethate Sodium for Injection I.P. 0.5 MIU Best Price in Mumbai Maharashtra, pricing should be evaluated alongside product quality, documentation, packaging, minimum order quantity, shipping terms, registration requirements, and delivery schedules rather than price alone.

Frequently Asked Questions

1. What is Colistimethate Sodium for Injection I.P. 0.5 MIU?

It is a sterile injectable antibacterial medicine containing colistimethate sodium and is used for certain serious bacterial infections under professional medical supervision.

2. Who manufactures Colistimethate Sodium for Injection I.P. 0.5 MIU in India?

Taj Medico is a pharmaceutical manufacturer and exporter based in the Vapi-Sarigam region of Gujarat, India.

3. Is Colistimethate Sodium an antibiotic?

Yes. Colistimethate sodium is a polymyxin antibacterial used against susceptible Gram-negative bacteria.

4. What is 0.5 MIU?

MIU means million international units. The stated strength is 0.5 million international units.

5. Is this injection suitable for home administration?

It should be administered according to the approved prescribing information and under appropriate healthcare-professional supervision.

6. Who can purchase this product?

Authorized pharmaceutical importers, distributors, hospitals, institutional buyers, wholesalers, and eligible healthcare businesses may inquire, subject to local laws.

7. Does Taj Medico export pharmaceutical products?

Yes. Taj Medico describes itself as a pharmaceutical exporter serving international markets.

8. Where is Taj Medico located?

Taj Medico’s manufacturing operations are located in the Vapi-Sarigam GIDC region of Gujarat, India.

9. Is Taj Medico WHO-GMP certified?

Taj Medico states on its website that its facility is WHO-GMP certified. Buyers should request current certification documentation during due diligence.

10. Does Taj Medico have EU-GMP approval?

The company states that it is working toward EU-GMP and PIC/S approvals; buyers should verify the current status before making regulatory claims or submissions.

11. Can packaging be customized?

Customized packaging and labeling may be possible depending on regulatory requirements, artwork, order quantity, and commercial terms.

12. Can buyers request a Certificate of Analysis?

Applicable batch and quality documentation can be discussed with the supplier according to the product and destination-market requirements.

13. Is a CTD dossier available?

CTD documentation requirements depend on the destination country and registration pathway. Buyers should request the relevant dossier package during regulatory discussions.

14. What documents are needed for pharmaceutical import?

Requirements vary by country but can include manufacturing authorization, GMP evidence, COPP where applicable, CoA, product specifications, stability information, labeling documents, and import authorization.

15. What infections can colistimethate sodium treat?

It may be used for serious infections caused by susceptible Gram-negative bacteria. Treatment must be based on clinical assessment and applicable prescribing guidance.

16. Does kidney function matter during treatment?

Yes. Colistimethate sodium requires particular attention to renal function because dosing and monitoring may need adjustment in patients with impaired kidney function.

17. What are possible adverse effects?

Reported effects can include gastrointestinal symptoms and neurological effects such as dizziness or paresthesia. Patients should promptly report concerning symptoms to their healthcare professional.

18. Can Taj Medico supply private-label products?

Taj Medico states that it offers private labeling and third-party/contract manufacturing services, subject to applicable product and regulatory requirements.

19. Can international distributors request quotations?

Yes. Authorized buyers can contact Taj Medico to discuss product specifications, quantity, packaging, documentation, destination market, and commercial terms.

20. How can I source Colistimethate Sodium for Injection I.P. 0.5 MIU from India?

Contact Taj Medico with your required quantity, destination country, packaging requirements, registration status, and documentation needs to receive product and export information.

Contact Taj Medico for Global Supply

If you are searching for a dependable Colistimethate Sodium for Injection I.P. 0.5 MIU Manufacturer, Supplier and Exporter in India, Taj Medico can be considered as a pharmaceutical sourcing partner from Vapi, Gujarat. Its WHO-GMP manufacturing positioning, quality-focused operations, regulatory support, export infrastructure, and international business capabilities make it relevant to authorized pharmaceutical buyers.