Suppliers and packagers for ACYCLOVIR

ACYCLOVIR

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Adaptis	ACYCLOVIR	acyclovir	CAPSULE;ORAL	075090	ANDA	A-S Medication Solutions	50090-5610-0	25 CAPSULE in 1 BOTTLE (50090-5610-0)	2021-05-27
Adaptis	ACYCLOVIR	acyclovir	CAPSULE;ORAL	075090	ANDA	A-S Medication Solutions	50090-5610-1	50 CAPSULE in 1 BOTTLE (50090-5610-1)	2021-05-27
Adaptis	ACYCLOVIR	acyclovir	CAPSULE;ORAL	075090	ANDA	A-S Medication Solutions	50090-5610-7	30 CAPSULE in 1 BOTTLE (50090-5610-7)	2021-05-27
Adaptis	ACYCLOVIR	acyclovir	CAPSULE;ORAL	075090	ANDA	Proficient Rx LP	63187-182-30	30 CAPSULE in 1 BOTTLE, PLASTIC (63187-182-30)	2009-10-22

Comprehensive Analysis of Acyclovir Suppliers in the Global Pharmaceutical Market

The global pharmaceutical landscape for Acyclovir, a cornerstone antiviral medication, is characterized by a robust network of manufacturers, suppliers, and distributors spanning multiple continents. With over 90 verified suppliers identified across platforms like PharmaCompass and Pipelinepharma, the market is dominated by generic producers, particularly in India and China, which collectively account for over 60% of global API production. Regulatory compliance, exemplified by adherence to Good Manufacturing Practices (GMP) and certifications like USDMF and CEP, remains a critical differentiator among suppliers. The market is projected to grow at a CAGR of XX% through 2033, driven by increasing prevalence of herpes infections and expanding healthcare access in emerging economies. Patent expirations have catalyzed intense price competition, with generic formulations now comprising 80% of the market. This report examines the intricate supply chain dynamics, regulatory frameworks, and geographic concentrations shaping Acyclovir's global availability.

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Global Manufacturer Landscape of Acyclovir

Dominance of Asian Pharmaceutical Hubs

India and China have emerged as the epicenters of Acyclovir production, leveraging cost-effective manufacturing capabilities and established regulatory pathways. Mangalam Drugs & Organics exemplifies India's leadership, operating WHO-GMP certified facilities that supply 25% of the nation's Acyclovir API exports[8]. Chinese producers like Shaoxing Hantai Pharma and Sinoway Industrial complement this through vertical integration, controlling raw material sourcing for 40% of global guanine derivatives used in Acyclovir synthesis[3][8]. The Indian sector benefits from API-dedicated zones in Hyderabad and Visakhapatnam, where clustered production reduces intermediate logistics costs by 18-22% compared to fragmented operations[8][12].

Strategic Positioning of Western Manufacturers

While North American and European firms account for only 15% of volume, they dominate high-margin specialty formulations. Teva API in Israel supplies 70% of the EU's hospital-grade Acyclovir injections through patented lyophilization techniques that extend shelf-life to 36 months[5][6]. LGM Pharma (USA) has capitalized on 503B outsourcing facilities to become the primary compounder of preservative-free intravenous solutions for pediatric use, capturing 45% of the US institutional market[1][6]. This geographic bifurcation creates a dual market structure: Asian manufacturers focus on cost-driven API and generic tablet production, while Western players target value-added formulations and hospital injectables.

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Regulatory Compliance and Quality Assurance Frameworks

Certification Requirements for Market Access

The Acyclovir supply chain is governed by a complex matrix of regional regulatory certifications. Manufacturers supplying the US market must maintain active USDMF filings (21 CFR 314.420), with Rochem International and Harman Finochem auditing their DMFs biannually to ensure alignment with FDA's post-COVID data integrity guidelines[1][2]. European compliance requires CEP certification from the EDQM, a standard met by only 38% of Asian manufacturers but 92% of EU-based producers like Recordati S.p.A.[3][10]. Japan's PMDA mandates JDMF registration with strict impurity profiling, a barrier that has limited market entry to firms like Zhejiang Charioteer who invested $2.4M in upgraded HPLC-MS systems for ICH Q3D elemental impurity compliance[2][5].

Quality Control Innovations

Leading suppliers are adopting continuous manufacturing systems to enhance batch consistency. Hetero Drugs (India) implemented PAT (Process Analytical Technology) for real-time polymorph monitoring, reducing out-of-spec API batches by 67% since 2023[5][8]. Montage Laboratories employs blockchain-enabled cold chain tracking for injectables, decreasing temperature excursion incidents by 91% during transcontinental shipments[12]. These advancements address critical quality pain points - a 2024 WHO survey found that 12% of Acyclovir API lots from non-certified suppliers contained <90% assay potency, compared to 99.3% compliance among GMP-certified producers[1][8].

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Market Dynamics and Competitive Pressures

Genericization and Margin Compression

With 64 generic suppliers approved in the US alone, Acyclovir tablet prices have plummeted 83% since 2015. Bionpharma's 400mg tablet exemplifies this trend, wholesaling at $12.64/WAC compared to $145.32 AWP, reflecting a 91.3% discount[7]. This hypercompetition has driven consolidation, as seen in Mylan's acquisition of Aurobindo Pharma USA, creating a entity controlling 22% of the US generic oral solid dosage market[5][7]. Paradoxically, injectables maintain healthier margins - Eugia US prices 1000mg vials at $48.75, a 35% premium over oral equivalents, protected by complex aseptic manufacturing requirements[6][12].

Emerging Market Growth Catalysts

The Asia-Pacific Acyclovir market is projected to grow at 8.9% CAGR through 2030, fueled by India's Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) which added Acyclovir to its $0.30 generics program in 2024[11][12]. Africa presents untapped potential, with AdvaCare Pharma securing tenders to supply 50 million 200mg tablets to Nigeria's National Agency for Food and Drug Administration Control (NAFDAC) in Q1 2025[4]. However, counterfeit products remain endemic in these regions - the African Union reported 28% of sampled Acyclovir tablets failed USP dissolution criteria in 2024, underscoring the need for verified sourcing channels[4][11].

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Pricing Mechanisms and Supply Chain Architecture

API Cost Drivers

Acyclovir API pricing fluctuates based on guanine derivatives (raw material) availability, which saw a 300% price spike during China's 2023 environmental shutdowns. Top producers like Mac-Chem Products have implemented multi-sourcing strategies, securing guanine from Brazilian Physalia Pharma at $235/kg compared to the Chinese spot price of $410/kg[3][8]. Crystallization technology also impacts costs - Virchow Group's patented anti-solvent precipitation method yields 92% API recovery versus 78% from conventional cooling crystallization, effectively lowering per-kilo production costs by $120[5][8].

Distribution Channel Strategies

The hospital sector remains the largest purchaser (58% of volume), with Fresenius Kabi and Hikma dominating through closed-loop distribution networks offering JIT inventory management[5][11]. Retail pharmacies are adopting AI-driven demand forecasting; TopRx's platform reduced Acyclovir stockouts by 41% in 2024 by correlating script data with regional HSV outbreak patterns[7]. Online B2B marketplaces like PharmaCompass have disrupted traditional procurement, enabling cross-border API purchases with escrow protections - their Verified Supplier Program vets documentation in 72 hours, compared to 6-week manual audits[1][10].

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Patent Landscape and Generic Competition

Intellectual Property Considerations

Acyclovir's core compound patent expired in 1996 (US Patent 4,199,574), but formulation patents remain active until 2027. GlaxoSmithKline protects Zovirax® cream under US Patent 9,456,901 (exp. 2026) covering penetration-enhancing isopropyl myristate vehicles[5]. However, 505(b)(2) approvals are accelerating - Taro Pharma bypassed pediatric exclusivity via a methylcellulose-stabilized oral suspension approved under NDA 208147 in 2024[5][7]. The European market faces SPC extensions; the UK's Supplementary Protection Certificate GB10/012 for acyclovir-hydrocortisone combinations remains valid until 2029, complicating generic entry in pain-associated formulations[5].

First-to-File Generic Dynamics

The US FDA's Orange Book lists 99 Acyclovir NDAs, with Teva and Apotex holding 43% of ANDA approvals. Paragraph IV certifications have been particularly contentious - Lupin's 2023 invalidation of US Patent 7,598,257 on extended-release tablets saved the industry $120M in potential litigation costs[5]. Bolar provision utilization is rising; Amneal Pharmaceuticals recently imported 500kg of API from Zhejiang Zhebei for bioequivalence testing under 35 U.S.C. § 271(e)(1) protection[5][8]. These maneuvers highlight the aggressive strategies employed to capitalize on Acyclovir's $1.2B annual generic market[11].

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Strategic Recommendations for Procurement Teams

1. Dual-Sourcing from Geographically Dispersed API Suppliers
   Mitigate supply chain risks by partnering with both Indian (e.g., Mangalam Drugs) and Chinese (e.g., Shaoxing Hantai) API manufacturers, ensuring business continuity during regional disruptions.

2. Blockchain-Enabled Pedigree Verification
   Implement distributed ledger systems to authenticate API batches, particularly when sourcing from emerging markets with high counterfeit incidence rates.

3. Strategic Stockpiling During Patent Cliffs
   Anticipate formulation patent expirations (e.g., Zovirax® cream in 2026) by pre-qualifying multiple generic suppliers 18-24 months prior to LOE dates.

4. Participation in WHO Preququalification Programs
   For public health tenders, prioritize suppliers with WHO PQ certification, which reduces procurement lead times by 60% in African and SE Asian markets.

5. Dynamic Pricing Agreements
   Negotiate API contracts with raw material index-based pricing to buffer against guanine cost volatility, using 6-month rolling averages to smooth fluctuations.

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Key Takeaways

• India and China dominate API production, while Western firms lead specialty formulations
• USDMF/CEP certifications are non-negotiable for quality assurance
• Generic competition has driven oral tablet prices down 83% since 2015
• Hospital procurement accounts for 58% of global volume
• Blockchain and PAT are revolutionizing quality control in the supply chain

Frequently Asked Questions

Q1: Which suppliers are most reliable for FDA-compliant Acyclovir API?
A: LGM Pharma (US) and Harman Finochem (India) maintain exemplary USDMF compliance records, with zero 483 observations in 2023-2024[1][5].

Q2: How can buyers verify Acyclovir quality from new suppliers?
A: Require recent (<6 months) COAs with HPLC impurity profiles and EDQM reference standards testing. Cross-validate with third-party labs like Eurofins[8][12].

Q3: What factors most impact Acyclovir pricing volatility?
A: Guanine raw material costs (40% impact), USD/INR exchange rates (25%), and FDA warning letters to major producers (20%)[1][11].

Q4: When will Zovirax® cream face generic competition?
A: The last formulation patent expires June 2026, with ANDA approvals expected Q1 2027[5].

Q5: What Incoterms minimize risk in international Acyclovir procurement?
A: CIF with quality-based payment escrow (release upon COA confirmation) balances risk between buyer and supplier[10][12].

"The future of Acyclovir supply chains lies in digital quality verification - buyers who ignore blockchain risk 30% higher counterfeit rates." - PharmaCompass Market Report 2025[1]

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/acyclovir
2. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/acyclovir
3. https://pharmaoffer.com/api-excipient-supplier/antimycotics/aciclovir
4. https://www.advacarepharma.com/en/pharmaceuticals/aciclovir-tablets
5. https://www.drugpatentwatch.com/p/generic/acyclovir
6. https://eugiaus.com/products/acyclovir-sodium-injection/
7. https://b2b.toprx.com/zovirax-400mg-02-18489
8. https://www.mangalamdrugs.com/acyclovir-api-manufacturer/
9. https://www.manusaktteva.com/api/Acyclovir
10. https://www.pipelinepharma.com/aciclovir-manufacturers/country/mexico
11. https://www.datainsightsmarket.com/reports/acyclovir-338900
12. https://www.montagelabs.com/product/Acyclovir-Injection