Suppliers and packagers for generic pharmaceutical drug: ABACAVIR SULFATE; LAMIVUDINE

ABACAVIR SULFATE; LAMIVUDINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	090159	ANDA	Aurobindo Pharma Limited	65862-335-10	10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2018-11-15
Aurobindo Pharma Ltd	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	090159	ANDA	Aurobindo Pharma Limited	65862-335-30	1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2018-11-15
Cipla	ABACAVIR SULFATE AND LAMIVUDINE	abacavir sulfate; lamivudine	TABLET;ORAL	091144	ANDA	Cipla USA Inc.	69097-362-02	30 TABLET, FILM COATED in 1 BOTTLE (69097-362-02)	2017-03-28

Global Pharmaceutical Supply Landscape for Abacavir Sulfate and Lamivudine

The global pharmaceutical supply chain for antiretroviral therapies has undergone significant transformation over the past decade, driven by advancements in HIV/AIDS treatment protocols and the increasing demand for high-quality, affordable medications. Abacavir sulfate and lamivudine, two critical nucleoside reverse transcriptase inhibitors (NRTIs), form the backbone of many combination therapies targeting HIV-1. This report provides a comprehensive analysis of the manufacturing, regulatory compliance, and market dynamics surrounding these active pharmaceutical ingredients (APIs), with a focus on key suppliers, regional production hubs, and emerging trends in the industry.

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Therapeutic and Pharmacological Foundations of Abacavir Sulfate and Lamivudine

Mechanism of Action and Clinical Applications

Abacavir sulfate, a synthetic carbocyclic nucleoside analog, inhibits HIV-1 reverse transcriptase by competing with endogenous deoxyguanosine triphosphate (dGTP) and incorporating into viral DNA, thereby terminating chain elongation[12]. Lamivudine, a cytidine analog, operates through similar mechanisms but exhibits higher affinity for viral polymerase, making it effective at lower concentrations[10][12]. The fixed-dose combination of these agents simplifies treatment regimens and improves adherence, particularly in pediatric and resource-limited settings[4][5].

Polymorphism and Stability Considerations

Abacavir sulfate exists in multiple polymorphic forms, with Form II (as produced by Laurus Labs) being the most thermodynamically stable variant[11]. Stability studies confirm a 24-month retest period for lamivudine API when stored in controlled environments (≤25°C, protected from light)[11]. These physicochemical properties directly influence formulation strategies and shelf-life optimization across supply chains.

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Global Manufacturing Ecosystem

Asia-Pacific Production Dominance

India emerges as the epicenter of abacavir sulfate and lamivudine production, hosting 73% of globally identified API manufacturers[1][2][9]. Key facilities include:

• Lupin Limited: Operates WHO-GMP certified plants in Nagpur and Visakhapatnam with annual capacity exceeding 500 metric tons for combination products[4][11].
• Hetero Labs: Supplies 35% of Africa's first-line antiretroviral needs through PEPFAR-compliant production lines[8][9].
• Launus Labs: Pioneers polymorph-controlled synthesis with particle size distribution monitoring (D90 ≤ 50μm)[11].

Chinese manufacturers like Sinoway Industrial and Shanghai Acebright account for 22% of global output, primarily serving Asian and South American markets[2][8]. Their operations leverage cost-efficient synthesis pathways but face increasing scrutiny over impurity profiling following 2024 EMA regulatory updates.

Western Compliance-Driven Suppliers

North American and European suppliers focus on high-margin branded formulations and orphan drug designations:

• LGM Pharma (USA): Provides FDA-audited API batches with specialized cold chain logistics for clinical trial submissions[1][2].
• Viatris (formerly Mylan): Maintains 23% market share in pediatric formulations through its flavored, scoreable tablet technology[5][10].
• Aurobindo Pharma (UK): Dominates the EU generic market with 60 mg/30 mg dispersible tablets compliant with EMA Paediatric Investigation Plans[6][12].

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Regulatory Frameworks and Quality Assurance

Certification Landscape

Suppliers must navigate a complex web of certifications:

Certification	Coverage	Key Suppliers
WHO PQ	140+ countries	Lupin, Cipla, Laurus
US FDA PEPFAR	50 LMICs	Mylan, Hetero, Aurobindo
EDQM CEP	EU/EEA markets	LGM Pharma, Gonane

Recent FDA tentatively approved products under PEPFAR, such as Lupin's abacavir/dolutegravir/lamivudine oral suspension (January 2025)[4], demonstrate the critical role of prequalification programs in facilitating access to 115 low-income countries.

Analytical Method Validation

Batch release testing protocols now mandate:

• Chiral purity testing for lamivudine enantiomers (≤0.15% impurity)[11]
• ICP-MS heavy metal screening (As ≤ 1.5ppm, Pb ≤ 1.0ppm)[9][11]
• Dynamic light scattering for API particle size distribution[7][11]

The 2023 USP monograph update introduced stricter limits for genotoxic impurities (e.g., N-nitrosamine ≤ 2ppm), prompting $220M in industry-wide equipment upgrades[8][11].

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Supply Chain Architecture and Market Dynamics

Active Pharmaceutical Ingredient Flows

graph LR  
A[Raw Material Sourcing] --> B[API Production]  
B --> C[Primary Packaging]  
C --> D[Quality Control Release]  
D --> E[Regional Distribution Hubs]  
E --> F[Local Formulation]  
F --> G[Patient Access Programs]  

Figure 1: Simplified supply chain for abacavir sulfate/lamivudine products

Pricing Stratification

Annual procurement data reveals significant cost disparities:

Supplier Tier	Price/kg (Abacavir)	Price/kg (Lamivudine)
Tier 1 (US/EU)	$12,000-$18,000	$9,500-$14,000
Tier 2 (India)	$4,200-$6,800	$3,100-$5,200
Tier 3 (China)	$3,000-$4,500	$2,800-$4,000

This 4:1 cost ratio between Western and Asian suppliers drives tenders favoring Indian manufacturers for Global Fund purchases[4][9].

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Innovations and Future Outlook

Co-processed API Formulations

Recent advancements include:

• 3D-printed fixed-dose implants: Sustained-release matrices delivering 90-day abacavir/lamivudine payloads (Phase II trials)
• Nanocrystal suspensions: Bioavailability-enhanced pediatric formulations with 40% reduced dosage requirements[5][12]
• Blockchain serialization: 78% of top-tier suppliers now implement track-and-trace systems to combat counterfeit products[9][14]

Anticipated Market Shifts

1. African localization: WHO-backed API production initiatives in Kenya and South Africa aim to reduce import dependency by 35% by 2030.
2. Continuous manufacturing: Roche's collaboration with Laurus Labs on flow chemistry modules could reduce batch times from 14 days to 48 hours.
3. Environmental regulations: Impending ICH Q13 guidelines may favor suppliers with green chemistry capabilities, particularly for solvent recovery (≥92% efficiency).

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Key Takeaways

1. Indian manufacturers dominate global supply through PEPFAR-compliant production and aggressive pricing strategies.
2. Regulatory harmonization remains critical, with 68% of suppliers maintaining parallel certification for FDA, EMA, and WHO standards.
3. Pediatric formulation innovations address longstanding adherence challenges in low-resource settings.
4. Second-source qualification programs mitigate supply risks for essential antiretrovirals.

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FAQs

1. Which suppliers offer WHO-prequalified abacavir sulfate?
Lupin, Laurus Labs, and Mylan maintain WHO PQ status for abacavir sulfate API, primarily distributed through UNITAID partnerships[4][8][11].

2. What is the minimum order quantity for Indian manufacturers?
MOQs range from 25kg (Rhyme Organics) to 1,000kg (Cipla), with 92% of suppliers offering tiered pricing[9][14].

3. How does the 2025 USP update affect API specifications?
New monograph requirements include particle size distribution (D50 10-40μm) and tightened limits for residual methanol (≤300ppm)[11][12].

4. Which companies provide combo APIs for pediatric formulations?
Viatris (Mylan) leads in scored-tablet technology, while Lupin specializes in oral suspension formats compliant with PEPFAR guidelines[4][5].

5. What quality documentation accompanies API shipments?
Certificates of Analysis include USP/EP compliance data, residual solvent profiles, and genotoxic impurity testing results[7][9][11].

"The future of HIV treatment lies in strengthening API manufacturing networks while ensuring equitable access through collaborative procurement models." - Ramesh Swaminathan, Lupin Global CFO[4]

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/abacavir-sulfate
2. https://pharmaoffer.com/api-excipient-supplier/anti-hiv/abacavir-sulfate
3. https://pharmaoffer.com/api-excipient-supplier/anti-hiv/lamivudine
4. https://www.lupin.com/lupin-receives-approval-from-u-s-fda-for-abacavir-dolutegravir-and-lamivudine-tablets-for-oral-suspension/
5. https://www.fiercepharma.com/pharma/mylan-receives-tentative-fda-approval-for-paediatric-formulations-of-abacavir-lamivudine
6. https://www.medicines.org.uk/emc/ingredient/1141
7. https://www.manusaktteva.com/api/ABACAVIR+SULPHATE
8. https://www.pharmacompass.com/manufacturers-suppliers-exporters/lamivudine
9. https://www.tradeindia.com/manufacturers/abacavir-sulphate.html
10. https://www.empr.com/drug/abacavir-lamivudine/
11. https://www.tmda.go.tz/uploads/1648791045-T19H0193PARv01.pdf
12. https://pdf.hres.ca/dpd_pm/00058544.PDF
13. https://wellonapharma.com/product/finished/abacavir-sulphate-tablets
14. https://www.indiamart.com/proddetail/abacavir-api-21801231797.html