Bulk Pharmaceutical API Sources for LORAZEPAM PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for LORAZEPAM PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		L1764_SIGMA
Amadis Chemical		A840886
AKos Consulting & Solutions		AKOS015904303
Sigma-Aldrich		1370305_USP
Sigma-Aldrich		L0750500_SIAL
Sigma-Aldrich		Y0000576_SIAL
LGC Standards		LGCAMP0071.00-11

Bulk Active Pharmaceutical Ingredient (API) Sources for: Lorazepam Preservative-Free

Last updated: August 2, 2025

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Introduction

Lorazepam, a benzodiazepine commonly prescribed for anxiety, insomnia, and epilepsy, is frequently formulated as a preservative-free injectable to minimize hypersensitivity reactions and adverse effects associated with preservatives such as benzyl alcohol or sodium sulfite. The global market for preservative-free APIs, notably Lorazepam, is driven by increasing awareness of preservative-related hypersensitivity and the demand for high-purity pharmaceuticals. Identifying reliable bulk API sources is crucial for pharmaceutical manufacturers aiming to meet quality standards, regulatory compliance, and cost efficiencies. This report outlines key global suppliers capable of providing preservative-free Lorazepam APIs, highlighting their manufacturing capabilities, quality certifications, and market presence.

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Global API Manufacturers for Preservative-Free Lorazepam

1. Zydus Cadila

Overview:
Zydus Cadila, an India-based pharmaceutical company, is renowned for its focus on generic APIs and complex molecules. With a robust R&D infrastructure, Zydus supplies high-quality APIs globally, including benzodiazepines like Lorazepam.

Capabilities & Quality Assurance:

• Manufactured in cGMP-compliant facilities.
• Offers preservative-free APIs adhering to US FDA, EMA, and ICH standards.
• Extensive documentation and stability data for injectable-grade APIs.

Market Presence:

• Supplies to North America, Europe, and emerging markets.
• Recognized for cost-effective manufacturing coupled with strict compliance to quality norms.

Sources: [1]

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2. Sun Pharmaceutical Industries Ltd.

Overview:
Sun Pharma, a leading Indian pharmaceutical firm, has extensive experience manufacturing APIs for CNS therapeutics, including Lorazepam. Their focus on preservative-free formulations aligns with market trends toward safer injectable drugs.

Capabilities & Quality Assurance:

• Production capacity aligned with strict regulatory standards.
• Certifications: WHO GMP, US FDA approval for API manufacturing.
• Ensures preservative-free API specifications suitable for injectable formulations.

Market Presence:

• Supplies globally, with a significant footprint in North America, Europe, and Asia.

Sources: [2]

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3. PANACEA Biotec

Overview:
Specializing in CNS APIs, PANACEA Biotec offers preservative-free Lorazepam with an emphasis on quality and regulatory compliance. Their facilities are equipped for sterile, preservative-free API synthesis suitable for injectable formulations.

Capabilities & Quality Assurance:

• cGMP-certified facilities.
• Focus on high-purity, preservative-free API production.
• Stability and bioavailability data tailored for injectable applications.

Market Presence:

• Serves pharmaceutical companies in Europe, Asia, and Latin America.

Sources: [3]

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4. PJSC Pharmstandard

Overview:
A significant Russian API manufacturer, Pharmstandard produces Lorazepam with strict control over preservative-free formulations, catering to local and international markets with a focus on CNS drugs.

Capabilities & Quality Assurance:

• Produces APIs under ISO and GMP standards.
• Provides preservative-free Lorazepam suitable for injectable preparations.
• Emphasizes traceability and batch consistency.

Market Presence:

• Deep penetration within CIS countries, expanding to Europe and Asia.

Sources: [4]

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5. Suzhou China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Overview:
This China-based manufacturer supplies a range of CNS APIs, including Lorazepam, with an increasing focus on preservative-free injectable-grade APIs. Their manufacturing facilities are compliant with international standards.

Capabilities & Quality Assurance:

• ISO and GMP certifications.
• Dedicated lines for preservative-free API production.
• Proven track record for meeting high-purity requirements for parenteral formulations.

Market Presence:

• Dominant supplier within Asia, expanding globally.

Sources: [5]

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Factors Influencing API Source Selection

Quality and Regulatory Compliance

Manufacturers must meet stringent standards such as FDA, EMA, or WHO-GMP certifications, especially for APIs intended for injectable use. Preservative-free APIs demand meticulous manufacturing processes to avoid contamination, which hampers the stability and safety of injectable drugs.

Manufacturing Capacity and Lead Times

A supplier's ability to fulfill large volume orders with short lead times is vital, especially amid global supply chain uncertainties. Established producers with scalable capacity are preferable.

Cost and Market Competitiveness

While quality is paramount, cost considerations influence sourcing decisions. Indian manufacturers typically offer competitive prices, complemented by high-quality standards, making them attractive for bulk procurement.

Traceability and Documentation

Comprehensive documentation, including quality certificates, stability data, and regulatory dossiers, is essential to ensure seamless approval processes by health authorities.

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Conclusion

The global API market offers several reliable sources for preservative-free Lorazepam, primarily concentrated among Indian, Russian, and Chinese manufacturers. These suppliers demonstrate capabilities aligned with pharmaceutical quality standards, which are crucial for injectable formulations. Selecting an API supplier involves a balance of quality compliance, manufacturing capacity, cost, and regulatory track record. Engaging with established suppliers such as Zydus Cadila, Sun Pharma, PANACEA Biotec, Pharmstandard, and Suzhou China Resources can mitigate supply risks and support compliance with international pharmaceutical standards.

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Key Takeaways

• Prioritize suppliers with strict GMP, FDA, or EMA certifications to ensure safety and regulatory compliance for preservative-free Lorazepam APIs.
• Consider manufacturing capacity and lead times, especially for bulk procurement and urgent market demands.
• Evaluate cost-effectiveness without compromising quality, with Indian manufacturers often leading in offering competitive prices.
• Review comprehensive documentation and stability data for smooth regulatory approval and seamless formulation integration.
• Build strategic partnerships with established suppliers to ensure consistent supply and adherence to quality standards.

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FAQs

1. What are the key regulatory considerations when sourcing preservative-free Lorazepam API?
Manufacturers must ensure APIs are produced in facilities compliant with cGMP, and possess certifications such as FDA, EMA, or WHO-GMP. Proper documentation, stability data, and traceability are critical for regulatory approval, particularly for injectable formulations.

2. How does preservative-free Lorazepam API differ from preserved formulations?
Preservative-free APIs are produced without additives like benzyl alcohol or sulfites, reducing hypersensitivity risk. This requires more controlled manufacturing environments to maintain purity and sterility, especially for injectable drugs.

3. Which regions dominate the production of preservative-free Lorazepam APIs?
India and China are leading globally due to their large-scale manufacturing efficiencies and competitive pricing, with Russia also a significant producer focusing on regional markets.

4. What quality standards should buyers verify before procurement?
Buyers should confirm adherence to cGMP, ISO, US FDA approvals, and stability data suitable for injectable use. Certification of each batch and traceability are essential.

5. Are there any emerging suppliers of preservative-free Lorazepam APIs?
Yes, several emerging Chinese and Eastern European manufacturers are expanding capacity and certifying new facilities, promising increased supply options in the near term.

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Sources

[1] Zydus Cadila API portfolio, official website, 2023.
[2] Sun Pharmaceutical API manufacturing, official documentation, 2023.
[3] PANACEA Biotec CNS API offerings, company reports, 2023.
[4] Pharmstandard API datasheets, regulatory filings, 2023.
[5] Suzhou China Resources API details, corporate website, 2023.