Bulk Pharmaceutical API Sources for ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23709358
IS Chemical Technology		I06-1711
Ambinter		ST51053206
ChemMol		49423629
Amadis Chemical		A836586
Ark Pharm, Inc.		AK-72994
Aurum Pharmatech LLC		M-1624

Bulk Active Pharmaceutical Ingredient (API) Sources for Acyclovir in Sodium Chloride 0.9% Preservative-Free Solution

Last updated: August 2, 2025

Overview

Acyclovir, a nucleoside analog antiviral agent, is predominantly utilized to treat herpes simplex virus (HSV) infections, including genital herpes, cold sores, and varicella-zoster virus (VZV) infections such as shingles. The pharmaceutical formulation of acyclovir as an injectable solution often involves dilution in a compatible carrier such as sodium chloride 0.9%, especially for intravenous administration. The preservative-free variant is crucial for sensitive patient populations, including neonates and immunocompromised individuals, where preservatives might induce adverse reactions.

Securing a reliable source of high-quality, pharmaceutical-grade acyclovir API is vital for manufacturers aiming to meet stringent regulatory standards and ensure patient safety. This article explores the leading global suppliers of acyclovir API suitable for manufacturing preservative-free intravenous formulations.

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Regulatory Standards and API Specifications

Acyclovir API intended for injectable formulations must comply with pharmacopoeial standards such as the USP, EP, or JP. Essential quality parameters include purity (≥99%), absence of residual solvents, microbial limits, and characterizations confirming the chemical structure. Suppliers offering APIs that are ISO-certified and adhere to GMP (Good Manufacturing Practice) standards provide the confidence needed for injectable fetch.

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Global API Suppliers for Acyclovir Sodium

1. Teva Pharmaceuticals

Overview:
Teva is a dominant player in generic pharmaceuticals, with extensive API manufacturing capabilities approved by authorities such as the FDA, EMA, and JP. Their acyclovir API is produced under strict GMP conditions, ensuring high purity and consistency.

Strengths:

• Large-scale manufacturing facilities
• Proven regulatory compliance
• Broad distribution network

Availability:
Teva's API is available for bulk purchase, with supplies suitable for injectable and capsule formulations, conforming to pharmacopoeial standards necessary for preservative-free applications.

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2. Hetero Labs Ltd.

Overview:
Hetero is an Indian-based pharmaceutical manufacturer with ISO and GMP certifications, specializing in a wide range of APIs including antivirals.

Strengths:

• Competitive pricing due to manufacturing efficiency
• Robust quality assurance processes
• Supply capacity for large orders

Availability:
Hetero’s acyclovir API is produced with specifications aligned to international standards, suitable for pharmaceutical formulations requiring high purity, such as preservative-free injections.

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3. Aurobindo Pharma

Overview:
Aurobindo is an established global API manufacturer with a significant portfolio in antivirals. Their acyclovir API is synthesized under cGMP conditions and verified for pharmacopoeial compliance.

Strengths:

• Consistent supply chain
• Extensive quality control
• Experience in injectable APIs

Availability:
Suitable for pharmaceutical companies focusing on high-quality, preservative-free formulations.

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4. Dr. Reddy's Laboratories

Overview:
A leading Indian pharmaceutical enterprise with authorization to produce and export pharmaceutical-grade APIs globally. Their acyclovir API manufacturing adheres to international GMP guidelines.

Strengths:

• Proven regulatory track record
• High purity standards
• Flexible supply options

Availability:
Their API can meet the purity and quality specifications needed for intravenous, preservative-free administration.

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5. Sandoz (Novartis)

Overview:
Sandoz, a Novartis division, specializes in biosimilars and generics, including APIs such as acyclovir. Their GMP-compliant manufacturing facilities produce APIs for sterile and non-sterile formulations.

Strengths:

• High-quality API supply chain
• Regulatory expertise
• Support for complex formulations

Availability:
Sandoz's acyclovir API suits manufacturers targeting high-standard, preservative-free sterile formulations.

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Key Considerations When Selecting an API Supplier

• Regulatory Compliance: Confirm that the supplier’s API manufacturing facilities are GMP-certified and that their API batches meet pharmacopoeial specifications.
• Purity and Quality Attributes: Ensure analytical data demonstrate ≥99% purity, low residual solvents, and absence of microbial contamination.
• Supply Chain Reliability: Evaluate supplier capacity to meet demand volume, lead times, and consistency.
• Documentation and Certifications: Request comprehensive Certificates of Analysis (CoA), Certificates of Suitability (COS), and compliance reports.
• Pricing and Contract Terms: Negotiate favorable terms aligned with your procurement and inventory management strategies.

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Conclusion

Securing high-quality acyclovir API from reputable, GMP-compliant suppliers is imperative for pharmaceutical manufacturers aiming to produce preservative-free, sodium chloride 0.9% solutions. Leading suppliers such as Teva, Hetero, Aurobindo, Dr. Reddy’s, and Sandoz possess the manufacturing expertise, regulatory compliance, and capacity to meet the demanding standards of sterile formulations. Due diligence in supplier qualification and thorough quality evaluation underpin successful procurement and consistent product quality for vulnerable patient populations.

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Key Takeaways

• Reliable sources of acyclovir API include Teva, Hetero, Aurobindo, Dr. Reddy’s, and Sandoz, all adhering to global GMP standards.
• API purity, regulatory certification, and supply chain stability are critical factors in supplier selection.
• Manufacturers targeting preservative-free injectable formulations must ensure APIs meet pharmacopoeial specifications for injections.
• Due diligence, including comprehensive documentation review, mitigates risk and ensures dosage safety.
• Strategic sourcing of high-quality acyclovir API supports compliance with quality standards and enhances patient safety in antiviral treatments.

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FAQs

1. What are the primary quality criteria for acyclovir API intended for injectable use?
The API must demonstrate purity ≥99%, low residual solvents, compliance with pharmacopoeial standards (USP, EP, JP), and meet microbial and endotoxin limits suitable for sterile formulations.

2. How do preservative-free formulations impact API sourcing?
Such formulations require APIs of the highest purity and stability, with no residual preservatives or contaminants that could compromise sterility or safety.

3. Are there regional differences in API suppliers for acyclovir?
Yes. Indian and Chinese manufacturers are prominent due to cost advantages and manufacturing capacity, while Western suppliers like Sandoz focus on stringent regulatory compliance and quality assurance.

4. Can these APIs be used interchangeably across regions?
Provided they meet international pharmacopoeial standards and possess proper certifications (e.g., CoA, COS), APIs are generally interchangeable, but regulatory approvals in target markets must be confirmed.

5. What role do regulatory authorities play in API qualification?
They set quality standards, approve manufacturing facilities, and require documentation such as GMP certifications, ensuring that APIs used in human medicines are safe and effective.

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References

1. United States Pharmacopeia (USP). USP Monograph for Acyclovir. [Online] Available from: https://www.uspnf.com
2. European Pharmacopoeia (EP). Monograph on Acyclovir. [Online] Available from: https://www.edqm.eu
3. GMP guidelines, WHO. Good Manufacturing Practices: Main principles. [Online] Available from: https://www.who.int
4. API supplier websites and corporate disclosures (Teva, Hetero, Aurobindo, Dr. Reddy's, Sandoz).
5. World Health Organization. Prequalification of Medicines Program (PQP) documentation.