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How To Find Best Manufacturers of Cefazolin Injection 250MG?

By: Ashok Kumar
|
18 Apr, 2025

In today’s ever-evolving pharmaceutical industry, sourcing high-quality injectable antibiotics like Cefazolin Injection 250mg is a crucial and challenging task. As healthcare institutions, distributors, and regulatory bodies around the world are constantly raising the bar for product quality, safety, and efficacy, it becomes crucial to choose manufacturers that meet all these parameters. 

At R K Lifecare INC, We have built our reputation through decades of pharmaceutical excellence, especially in the field of dry injectable products like Cefazolin.

In this blog, we will discuss in-depth how you can identify the best Cefazolin Injection 250mg manufacturers in India, and what makes R K Lifecare INC. stand out in this demanding and critical sector.

Chapter 1: Understanding Cefazolin Injection 250mg

What is Cefazolin?

Cefazolin is a first-generation cephalosporin antibiotic primarily used to treat a variety of bacterial infections. It acts by inhibiting bacterial cell wall synthesis, making it highly effective against gram-positive and some gram-negative bacteria.

Dosage Form: Dry Powder for Injection

Cefazolin Injection 250mg is commonly available as a dry powder, which requires reconstitution with sterile water prior to intravenous (IV) or intramuscular (IM) administration.

Why 250mg?

While higher doses such as 500 mg and 1 gram are commonly used in the hospital, 250 mg is often prescribed for mild to moderate infections, pediatric use, or step-down therapy after initial high-dose treatment.

Chapter 2: Clinical Uses and Therapeutic Importance

Approved Indications

Cefazolin Injection 250mg is used in the treatment of:

  • Respiratory tract infections

  • Urinary tract infections

  • Skin and soft tissue infections

  • Bone and joint infections

  • Biliary tract infections

  • Endocarditis (prophylactic use during surgeries)

Mode of Administration

Cefazolin is administered either:

  • Intramuscularly (IM) – For mild infections

  • Intravenously (IV) – For severe or systemic infections

Pharmacokinetics

  • Absorption: Immediate post-injection

  • Half-life: ~1.8 hours

  • Excretion: Renal (unchanged form)

  • Bioavailability: 100% IV; well-absorbed IM

Chapter 3: Source of Production – How is Cefazolin Manufactured?

Cefazolin sodium is a semi-synthetic cephalosporin derived from 7-ACA (7-aminocephalosporanic acid). The production process includes:

1. Raw Material Sourcing

  • 7-ACA is sourced from Penicillium chrysogenum fermentation.

  • Precise quality control ensures the purity and consistency of the base compound.

2. Synthesis of Cefazolin Sodium

  • Acylation of 7-ACA with specific side chains

  • Crystallization and purification to obtain the active pharmaceutical ingredient (API)

3. Formulation

  • Mixing of Cefazolin Sodium with suitable excipients

  • Filling into sterile vials under aseptic conditions

  • Lyophilization (freeze-drying) for shelf-stable dry powder formulation

4. Quality Control & Compliance

  • Sterility testing

  • Particulate matter analysis

  • pH and assay testing

  • Container integrity checks

At R K Lifecare INC, all these steps are conducted in WHO-GMP facilities using state-of-the-art equipment and strict quality protocols.

Chapter 4: What Makes a Cefazolin Manufacturer the “Best”?

1. Regulatory Compliance

Top manufacturers must hold certifications and adhere to global standards such as:

  • WHO-GMP

  • ISO 9001:2015

  • EU-GMP (for export)

  • cGMP under US FDA guidelines

2. Experience in Cephalosporin Manufacturing

Cefazolin is part of a sensitive class of antibiotics requiring dedicated facilities. Look for companies with:

  • Dedicated beta-lactam blocks

  • Proven history in sterile injectable manufacturing

  • Successful track record in domestic and export markets

3. In-House Quality Assurance and R&D

From stability studies to impurity profiling, in-house QA/QC departments ensure:

  • Consistent batch quality

  • Pharmacopoeial compliance (IP, USP, BP)

  • Timely delivery with zero recalls

4. Supply Chain Transparency

  • End-to-end traceability of raw materials

  • Real-time batch monitoring

  • Transparent documentation and COAs

Chapter 5: Why Choose R K Lifecare INC for Cefazolin Injection 250mg?

At R K Lifecare INC, we don’t just manufacture Cefazolin — we build trust with every vial. Here's how:

1. Decades of Experience

R K Lifecare INC has emerged as one of India’s most trusted manufacturers of dry injection formulations, especially in Cephalosporins.

2. State-of-the-Art Facility in Jhajjar, Haryana

  • Dedicated Cephalosporin Block

  • Aseptic Filling Zone with HEPA filtration

  • Isolator-based filling lines for maximum sterility

  • Lyophilization equipment from top global suppliers

3. Global Standards and Certifications

We hold and comply with:

  • WHO-GMP

  • ISO 9001:2015

  • DCGI License for sterile injectables

  • Regular audits from third-party clients and regulatory bodies

4. Proven Export Track Record

We export to more than 20 countries, delivering to both:

  • Government procurement agencies

  • Private label distributors

All products are backed by COA, stability data, and Dossiers upon request.

5. Customization and Contract Manufacturing

We offer:

  • Third-party manufacturing

  • Private labeling

  • Contract manufacturing services (CDMO)

Clients can get custom packaging, labeling, and branding, tailored to their target market.

Chapter 6: How to Evaluate a Cefazolin Manufacturer: A 10-Point Checklist

Criteria Must-Have
WHO-GMP Certification
Dedicated Cephalosporin Line
Lyophilization Capabilities
Export License & Dossiers
In-House Microbiology Lab
Track Record with Cefazolin
IP/USP/BP Compliance
Custom Labeling & OEM Options
Cold Chain Logistics (if needed)
Batch-to-Batch Consistency

Chapter 8: FAQs about Cefazolin Injection 250mg Manufacturers

Q1. What is the difference between Cefazolin Injection 250mg and 500mg?

The main difference lies in the dosage strength. 250mg is used for milder infections or pediatric cases, whereas 500mg or 1g are suited for severe infections.

Q2. Can R K Lifecare INC provide stability data and COAs?

Yes, we offer complete documentation, including COA, batch release certificates, and real-time and accelerated stability data.

Q3. How do you ensure sterility?

All manufacturing is done in Class 100 aseptic conditions. We follow USP <71> sterility testing, conducted both in-process and on finished vials.

Chapter 9: Final Thoughts — Your Trusted Partner for Cefazolin Injection 250mg

Choosing the right manufacturer for Cefazolin Injection 250mg isn’t just about finding the cheapest source — it’s about finding a reliable, experienced, and quality-focused partner who understands your needs.

With R K Lifecare INC, you get:

  • Scientific Rigor

  • Regulatory Clarity

  • Unwavering Product Quality

  • Transparent Operations

  • Customer-Centric Service

Ready to Partner with the Best?

If you’re a distributor, hospital procurement officer, government tender manager, or a private label brand — R K Lifecare INC is your go-to manufacturer for Cefazolin Injection 250mg in India.