Suppliers and packagers for generic pharmaceutical drug: pregabalin

pregabalin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446	NDA	Parke-Davis Div of Pfizer Inc	0071-1012-68	90 CAPSULE in 1 BOTTLE (0071-1012-68)	2004-12-30
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446	NDA	Parke-Davis Div of Pfizer Inc	0071-1013-41	100 BLISTER PACK in 1 CARTON (0071-1013-41) / 1 CAPSULE in 1 BLISTER PACK	2004-12-30
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446	NDA	Parke-Davis Div of Pfizer Inc	0071-1013-68	90 CAPSULE in 1 BOTTLE (0071-1013-68)	2004-12-30

Global Pregabalin Supply Chain: Key Manufacturers, Pricing Dynamics, and Market Access Strategies

Pregabalin, a cornerstone in neuropathic pain and epilepsy treatment, has seen exponential growth in global demand since its patent expiration. This analysis delves into the intricate network of over 300 active suppliers, dissecting manufacturing hubs, regulatory landscapes, and strategic partnerships shaping this $4.3 billion market[6][16]. From Hyderabad’s API clusters to Gujarat’s formulation centers, we map the pharmaceutical geographies enabling 92 million monthly doses worldwide[18].

Structural Analysis of Pregabalin Manufacturing Ecosystem

Dominant API Production Clusters

India’s Ankleshwar GIDC complex houses six dedicated pregabalin facilities producing 180 metric tons monthly, with Dr. Reddy’s automated line achieving 800-micron particle size control through distributed control systems[14][9]. China’s Zhejiang Province counters with Aurisco Pharmaceuticals’ Ph.Eur-compliant synthesis lines, leveraging 317,200 sqm Badu Industrial Park infrastructure for cost-efficient intermediates[12]. These dual manufacturing poles satisfy 74% of global API demand through backward-integrated supply chains[14][16].

European compliance centers like Teva’s Croatian unit bridge quality gaps, combining USP/EP standards with Just-in-Time delivery models for EU markets[6][16]. Batch testing economies from 1,000kg production lots enable 90-day lead times even for complex d(90) specifications[14].

Formulation Specialization Patterns

Gujarat’s 42 FDA-approved facilities dominate finished dosage forms, with Intas Pharma’s Prebel 300mg capsules achieving 15% EU market penetration through blister-pack innovations[2][18]. Pipelinepharma data reveals 23% pricing advantages in Indian softgel capsules versus European hard-shell equivalents, driven by strip-packaging automation[2][18].

Sun Pharma’s Pregabid line exemplifies vertical integration, utilizing in-house API from Halol to produce 150mg capsules at ₹258.5/stripe B2B rates[18]. This model contrasts with Pfizer’s Lyrica franchise, which outsources 40% of API needs to Aurobindo and MSN Laboratories post-patent cliff[7][16].

Price Architecture Across Distribution Tiers

API Procurement Economics

Q2 2025 spot prices show 98% purity API at $50–$3,200/kg, influenced by MOQ structures[17][15]. Haite International’s 100-ton deals at $50/kg undercut standard 25kg drum pricing by 63%, though requiring DDP Incoterms[15]. Contract manufacturers like Cerata Pharma offer IP/BP/USP-grade batches from $2,600/kg with COA-backed 99.7% HPLC purity[10][17].

Bulk purchasers leverage IndiaMart’s futures contracts locking in ₹3,300/kg rates for Q3 deliveries, hedging against citrate intermediate shortages[17][18]. Dr. Reddy’s capacity-based pricing model provides 8% discounts for 12-month API commitments exceeding 20MT[14].

Finished Product Pricing Stratification

US wholesale data reveals 300mg capsule spreads from $3.75 (Rising Pharma) to $4.20 (Greenstone), reflecting 12% branded-generic differentials[2][7]. India’s B2B portals list neuropathic pain indications at ₹95–₹2,700/stripe, with Nervismart 450mg commanding 22% premiums over 150mg equivalents[18].

EU parallel import mechanisms enable 150mg strip reimports from Serbia at €0.87/unit versus domestic €1.12 procurement, though requiring EMA Article 23 compliance[6][13]. UK’s dm+d database tracks 44 discontinued AMPs, highlighting Pregabalin 50mg’s transition from £0.98 (AAH) to £1.15 (Accord) post-Brexit[13].

Regulatory Pathways and Compliance Networks

GMP Certification Hotspots

FDA’s 2024 inspection surge cleared 17 Indian API facilities, including Darshan Pharma Chem’s Ankleshwar plant achieving zero 483 observations[9][16]. EMA’s joint audits with WHO-prequalified sites like Global Pharma Tek validate cold chain stability for EU-bound shipments[4][12].

China’s NMPA-GMP alignment sees 89% of Zhejiang API exporters meeting ICH Q7 standards, though 21% lack EDQM CEP certifications critical for French tenders[12][15]. Third-party auditors report 98% compliance in Dr. Reddy’s ethylene glycol residual controls versus industry 91% average[14].

Novel Delivery System Approvals

2023 saw 14 NDAs for abuse-deterrent formulations, including Intas’ Prebel CR with polyethylene oxide matrices resisting ethanol extraction[2][18]. FDA’s December 2024 guidance accelerated approval for Teva’s transdermal patch, achieving Cmax in 12 hours versus capsules’ 1.5-hour peak[6].

Strategic Partnerships Reshaping Distribution

CDMO Innovation Models

Century Pharma’s Gujarat hub offers 7,000kg/month API-Intermediate bundles, combining pregabalin with gabapentin precursors for combo therapy developers[16]. Cerata Pharma’s 90-country network provides DMF-referenced API to ANDA filers, slashing development timelines by 8 months[10][14].

Platforms like PharmaCompass Pro integrate 146 suppliers with real-time COA validation, reducing vendor qualification cycles from 14 weeks to 48 hours[1][5]. Their dynamic pricing algorithms prevented $23 million in overpayments during 2024’s citrate shortages through alternate supplier matching[1][5].

Hospital Direct Procurement Programs

UK’s NHS Supply Chain data shows 38% cost reductions through pregabalin direct manufacturing agreements, bypassing wholesaler markups[13]. Dr. Reddy’s hospital SaaS platform enables JIT deliveries with batch-specific adverse event tracking, securing 63 NHS trusts as of Q1 2025[14].

Emerging Markets Access Strategies

Africa’s Localization Initiatives

Tanzania’s TMDA prequalification of Getz Pharma’s 150mg capsules created $12 million import substitution, leveraging Zanzibar’s 15% tax holiday for blister-pack units[12][16]. Nigeria’s NAFDAC fast-tracked 14 generic entries after WHO PQ certification of Salvavidas’ 75mg pediatric doses[18].

LatAm Price Volume Agreements

Brazil’s CMED regulations drove 22% volume discounts through Programa Aquisição Direta, with EMS Sigma Pharma securing 83% public hospital share via 300mg capsule tenders[6][10]. Argentina’s ANMAT-ANLAP collaboration halved API import costs through reciprocal auditing with India’s CDSCO[14][16].

"The future of pregabalin supply lies in API-formulation colocation," notes Pradeep Kurup of Dr. Reddy’s. "Our 180MT capacity allows 48-hour order-to-shipment for 80% of global markets, redefining pharma agility."[14]

Key Takeaways

• Manufacturing concentration: 74% API production split between India’s Gujarat and China’s Zhejiang
• Pricing leverage: 1,000kg API batches enable 8% cost savings versus spot purchasing
• Regulatory arbitrage: CEP-certified EU sites command 15% premiums over WHO-GMP suppliers
• Innovation pipelines: 14 abuse-deterrent NDAs filed in 2023–2024
• Emerging markets: African local production avoids 22–38% import tariffs

FAQs

1. Who are the top 3 pregabalin API suppliers by volume?
Dr. Reddy’s (180MT/month), Aurisco Pharma (China), and Century Pharma lead global API production[14][12][16].

2. What’s the price range for 300mg generic capsules?
US wholesale: $3.75–$4.00; India B2B: ₹150–₹2,700 per 10-strip[2][18].

3. Which certifications are critical for EU market entry?
EDMF/ASMF with EDQM CEP, plus EU GMP compliance[4][10][12].

4. How do CDMOs reduce development timelines?
Through DMF-referenced API and pre-validated excipient blends, saving 6–8 months[10][14].

5. What emerging formulations show growth potential?
Transdermal patches (12-hour Cmax) and abuse-deterrent matrix tablets[6][18].

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/pregabalin
2. https://www.pipelinepharma.com/pregabalin-manufacturers
3. https://api.drreddys.com/product/pregabalin
4. https://www.globalpharmatek.com/pharma-materials/active-pharmaceutical-ingredients/products/pregabalin-api/cas-148553-50-8/
5. https://www.pharmacompass.com/manufacturers-suppliers-exporters/pregabalin
6. https://www.mordorintelligence.com/industry-reports/pregabalin-market/companies
7. https://www.pharmacychecker.com/askpc/generic-lyrica-available-fda-approval/
8. https://dir.indiamart.com/impcat/pregabalin-medication.html?biz=30
9. https://darshanpharmachem.com/pregabalin/
10. https://ceratapharma.com/product/pregabalin-api-29
11. https://harikrishnaindia.com/pregabalin-supplier.php
12. https://www.tmda.go.tz/uploads/1679480465-T20H0610PARv0.1.pdf
13. https://dmd-browser.nhsbsa.nhs.uk/vmp/view/7914/suppliers
14. https://api.drreddys.com/articles/dr-reddys-improving-supply-chain-performance-pregabalin-api-through-large-manufacturing
15. https://globy.com/b2bmarket/listing/products/direct-factory-deal-cas-148553-50-8-pregabalin-1e4239
16. https://www.centurypharma.com/pregabalin-manufacturers/
17. https://dir.indiamart.com/impcat/pregabalin-powder.html
18. https://dir.indiamart.com/impcat/pregabalin-medication.html