ACYCLOVIR SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	203701	ANDA	Eugia US LLC	55150-154-10	10 VIAL, SINGLE-DOSE in 1 CARTON (55150-154-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2013-10-11
Eugia Pharma	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	203701	ANDA	Eugia US LLC	55150-154-11	10 VIAL, SINGLE-DOSE in 1 CARTON (55150-154-11) / 10 mL in 1 VIAL, SINGLE-DOSE	2013-10-11
Eugia Pharma	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	203701	ANDA	AuroMedics Pharma LLC	55150-154-10	10 VIAL, SINGLE-DOSE in 1 CARTON (55150-154-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2013-10-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Acyclovir sodium, commonly known as acyclovir sodium, is a widely prescribed antiviral medication primarily used to treat herpes simplex virus infections, including genital herpes, cold sores, and shingles. As demand for antiviral therapeutics continues to grow globally, securing reliable suppliers for acyclovir sodium is crucial for pharmaceutical manufacturers, distributors, and healthcare providers. This article explores the key suppliers, their manufacturing capabilities, quality standards, and market positioning within the acyclovir sodium supply chain.

Overview of Acyclovir Sodium

Acyclovir sodium is the sodium salt form of acyclovir, enhancing its solubility and bioavailability. It is produced through complex chemical synthesis involving acyclovir active pharmaceutical ingredient (API) production, followed by salt formation. The pharmaceutical industry requires suppliers who adhere to strict regulatory standards, including cGMP compliance, to ensure product consistency and safety.

Major Suppliers of Acyclovir Sodium

1. Hetero Labs Limited

Profile:
Hetero Labs, based in India, stands as a leading manufacturer of active pharmaceutical ingredients (APIs) including acyclovir sodium. Established in the 1990s, Hetero has evolved into a global supplier with a robust export footprint across North America, Europe, and Asia.

Manufacturing Capabilities:
Hetero produces acyclovir sodium under stringent cGMP conditions with multiple production sites. Their facilities comply with US FDA, EMA, and other international regulatory standards, ensuring high-quality API output. The company emphasizes process optimization to deliver cost-effective and high-purity acyclovir sodium.

Quality Assurance:
Hetero's APIs are certified and undergo rigorous testing, including HPLC, NMR, and residual solvent analysis. They maintain strict control over impurity profiles, meeting or exceeding pharmacopeial requirements.

Market Position:
Hetero's competitive pricing and reliable supply chain have made it a preferred supplier for generic pharmaceutical companies worldwide.

2. Sun Pharmaceutical Industries Ltd.

Profile:
Sun Pharma, India's largest pharmaceutical company, produces a wide range of APIs, including acyclovir sodium. The company operates globally, with manufacturing facilities adhering to international quality standards.

Manufacturing Capabilities:
Sun Pharma's acyclovir sodium production lines utilize advanced synthetic routes, ensuring high purity and consistent batch quality. Their facilities are approved by major regulatory agencies, supporting global distribution.

Quality Assurance:
Extensive testing, including impurity profiling and stability assessments, ensures compliance with pharmacopeial standards. Sun Pharma has received multiple certifications, reinforcing its reliability as a supplier.

Market Position:
Known for its extensive distribution network, Sun Pharma can supply large volumes of acyclovir sodium with short lead times and competitive pricing.

3. CAMLIN Fine Sciences Ltd.

Profile:
CAMLIN Fine Sciences, based in India, specializes in manufacturing APIs and intermediates, including acyclovir sodium, for both domestic and international markets.

Manufacturing Capabilities:
Their facilities are certified under cGMP, focusing on quality management and process control. The company offers custom synthesis options and flexible batch sizes.

Quality Assurance:
CAMLIN emphasizes quality through rigorous analytical testing, transparency in impurity profiles, and adherence to regulatory standards, including USFDA and EMA guidelines.

Market Position:
CAMLIN’s niche positioning as a reliable supplier ensures steady availability of high-quality acyclovir sodium for generic manufacturers.

4. Hovid Berhad

Profile:
Hovid Berhad, a Malaysian pharmaceutical company, produces various APIs including acyclovir sodium, with a focus on quality and affordability.

Manufacturing Capabilities:
Hovid's manufacturing processes conform to international GMP standards, with capacity for large-scale production optimized for global exports.

Quality Assurance:
The company conducts comprehensive testing, including testing for residual solvents, heavy metals, and biological contaminants. Their APIs meet major regulatory requirements.

Market Position:
Hovid’s reputation for quality and competitive export pricing makes it a notable supplier in Southeast Asia and beyond.

5. Zhejiang Hisun Pharmaceutical Co., Ltd.

Profile:
Based in China, Zhejiang Hisun Pharmaceutical is among leading Chinese suppliers of APIs, including acyclovir sodium.

Manufacturing Capabilities:
The company utilizes modern synthetic processes and has obtained certifications such as ISO, GMP, and DMF. Their acyclovir sodium productions meet global quality standards, with an emphasis on cost-effective manufacturing.

Quality Assurance:
Strict analytical testing regimes ensure product purity, with detailed impurity profiling aligned with pharmacopeial standards.

Market Position:
With aggressive pricing and export focus, Zhejiang Hisun caters to budget-conscious markets, including emerging economies.

Regulatory Considerations and Quality Standards

Suppliers of acyclovir sodium must comply with international regulatory standards to ensure market acceptance:

cGMP Compliance: Ensures consistent quality and batch-to-batch uniformity.
Certifications: US FDA, EMA, ISO, and other regulatory bodies' approvals bolster supplier credibility.
Analytical Testing: High-performance liquid chromatography (HPLC), nuclear magnetic resonance (NMR), and residual solvent analysis are standard.
Impurity Profile: Strict control minimizes associated impurities, ensuring safety and efficacy.

Market Trends and Supply Chain Dynamics

The global demand for acyclovir sodium remains robust due to increasing herpes virus infections and the expansion of antiviral treatment options. Supply chain stability hinges on:

Manufacturing Diversification: Reliance on multiple suppliers reduces risks of shortages.
Regulatory Compliance: Suppliers maintaining high-quality standards are preferred amid evolving regulatory landscapes.
Price Competition: Chinese and Indian suppliers offer cost-effective options driven by economies of scale and manufacturing efficiencies.
Supply Chain Disruptions: Geopolitical events, raw material shortages, or logistical issues can impact supply continuity.

Emerging Suppliers and Future Outlook

New entrants from India, China, and other manufacturing hubs are expanding capabilities, incentivized by rising demand and technological advancements. Strategic partnerships, quality assurance, and regulatory compliance will remain critical for supplier selection.

Key Takeaways

Reliable acyclovir sodium suppliers include industry leaders like Hetero Labs, Sun Pharma, CAMLIN Fine Sciences, and regional players such as Hovid Berhad and Zhejiang Hisun Pharmaceutical.
Suppliers must demonstrate cGMP compliance, regulatory approvals, strict impurity control, and consistent quality to meet international standards.
Price competitiveness is primarily driven by manufacturing efficiencies in India and China, but quality remains paramount.
Diversification of suppliers mitigates risks amid global supply chain uncertainties.
Continuous monitoring of regulatory changes and market trends is essential for sourcing strategies.

FAQs

1. What are the primary criteria for selecting a supplier of acyclovir sodium?
Ensure their compliance with cGMP standards, regulatory approvals (FDA, EMA), rigorous analytical testing protocols, consistent supply history, and competitive pricing.

2. Are Chinese and Indian suppliers equally reliable for acyclovir sodium?
Many are highly reliable if they possess proper certifications, such as ISO, GMP, and national regulatory approvals. Due diligence and audits are advised before engagement.

3. How does price influence the choice of acyclovir sodium supplier?
While price is significant, it should not compromise quality. Balance Cost-of-Goods-Sold (COGS) with regulatory compliance and supplier reliability.

4. What are the challenges in sourcing acyclovir sodium internationally?
Supply chain disruptions, regulatory compliance, raw material availability, and geopolitical factors can pose challenges.

5. Will the supply of acyclovir sodium increase in the near future?
Yes, driven by rising demand for antiviral therapies globally, leading to expanded manufacturing capacities, especially in India and China.

References

[1] Market and industry reports on antiviral APIs, 2022.
[2] CPhI Report on API Manufacturing, 2021.
[3] US FDA and EMA certification data, 2022.
[4] Company websites and official disclosures.

Suppliers and packagers for generic pharmaceutical drug: ACYCLOVIR SODIUM