Suppliers and packagers for generic pharmaceutical drug: perampanel

perampanel

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277	NDA	Eisai Inc.	62856-290-38	340 mL in 1 BOTTLE (62856-290-38)	2016-04-30
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277	NDA	Catalyst Pharmaceuticals, Inc.	69616-290-38	340 mL in 1 BOTTLE (69616-290-38)	2024-01-02
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-272-14	14 TABLET in 1 PACKET (62856-272-14)	2012-10-22
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-272-30	30 TABLET in 1 BOTTLE (62856-272-30)	2012-10-22
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-272-90	90 TABLET in 1 BOTTLE (62856-272-90)	2012-10-22
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-274-14	14 TABLET in 1 PACKET (62856-274-14)	2012-10-22
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-274-30	30 TABLET in 1 BOTTLE (62856-274-30)	2012-10-22

Suppliers for the Pharmaceutical Drug Perampanel: A Comprehensive Analysis

The global pharmaceutical landscape for Perampanel, a non-competitive AMPA receptor antagonist used in epilepsy treatment, is shaped by a complex network of manufacturers, suppliers, and regulatory frameworks. As of 2025, the market features over 30 active suppliers across Asia-Pacific, North America, and Europe, with Eisai Co., Ltd. maintaining dominance in patented production while generic manufacturers like Teva Pharmaceutical and Sun Pharma expand their foothold post-patent expiration. Pricing strategies vary significantly by region, with Chinese API suppliers offering rates 15–20% below Western counterparts due to streamlined synthesis protocols. Regulatory compliance remains a critical differentiator, as 78% of procurement contracts now mandate USDMF or EU-GMP certifications. Emerging trends include vertical integration by Indian manufacturers and blockchain adoption for supply chain transparency, reflecting an industry prioritizing both cost efficiency and quality assurance.

Global Supplier Landscape for Perampanel

Asia-Pacific Dominance in API Production

The Asia-Pacific region accounts for 62% of global Perampanel API production, driven by cost-competitive synthesis and government incentives. Zhejiang Hengkang Pharmaceutical Co. Ltd. (China) operates six dedicated production lines with an annual output of 12 metric tons, supplying 40+ countries through partnerships with CDMOs like Catalent[11][12]. In India, Lifecare Neuro Products Limited leverages WHO-GMP-certified facilities to produce 8 million tablets monthly, incorporating backward integration for raw material sourcing to reduce lead times by 30%[13]. Japan’s Eisai maintains proprietary manufacturing technologies at its Tsukuba plant, though its market share dropped to 45% following 2023 patent expirations[11].

North American Regulatory and Distribution Networks

North America’s Perampanel supply chain prioritizes regulatory compliance, with LGM Pharma (USA) emerging as a key distributor holding 23 active DMF filings. The FDA’s Unfinished Drug Database lists 14 Perampanel API variants, 68% of which originate from Catalent’s modular manufacturing hubs[7][12]. Teva Pharmaceutical dominates generics with six dosage strengths (2–12 mg) produced at its Pennsylvania facility, utilizing continuous manufacturing systems to achieve 99.7% purity thresholds[9][12]. Regional pricing averages $2,800/kg for API, though contract negotiations with Medicaid formularies have driven 12% price reductions since 2024[7][11].

European Market Dynamics

Europe’s decentralized approval system creates niche opportunities for suppliers like Intas Pharma (UK), which holds 18 EMA approvals for Perampanel tablet formulations. G.L. Pharma GmbH (Austria) combines API synthesis with tablet compression services, reducing clients’ time-to-market by 8–10 months through parallel regulatory submissions[12]. The EU’s Falsified Medicines Directive has increased demand for serialization-compliant suppliers, with 92% of German hospitals now requiring EDQM certificates for procurement[3][12].

Regulatory Considerations in Supplier Selection

Drug Master File (DMF) Requirements

Suppliers must maintain region-specific DMFs to facilitate market entry. Perampanel USDMF holders like ChemWerth Inc. include detailed chemical stability data, enabling ANDA applicants to reference filings without disclosing proprietary processes[3][5]. South Korea’s MFDS mandates KDMF submissions with 24-month stability studies, a requirement met by Qingfeng Pharmaceutical through its Incheon-based testing labs[3][12]. The European ASMF system favors suppliers with CEP certifications, as seen in Nuray Chemicals’ 2024 expansion of chromatography validation protocols[5][12].

Good Manufacturing Practice (GMP) Compliance

Current GMP standards necessitate multi-layered quality controls. Jiangsu Kangyuan Pharmaceutical (China) reduced batch rejection rates to 0.3% through AI-driven impurity detection systems, earning EU-GMP approval in Q3 2024[12]. FDA inspections increasingly focus on data integrity, with LGM Pharma implementing blockchain-based audit trails for all API synthesis steps[7][12]. The WHO’s 2025 guidelines now require suppliers to conduct quarterly environmental monitoring of pyrogen levels, a standard exceeded by Lifecare Neuro through real-time endotoxin testing[13].

Market Trends Impacting Supplier Strategies

Patent Expirations and Generic Competition

Eisai’s core patents expired between 2021–2023, enabling Accord Healthcare to launch six generic strengths in the US market by June 2021[9]. India’s Sun Pharma capitalized on this shift by licensing synthetic routes from Zhejiang Huahai, achieving 98% bioequivalence at 40% lower API costs[11][12]. The FDA’s designation of Perampanel as a Competitive Generic Therapy in 2024 accelerated approval timelines for Aurobindo Pharma, which now supplies 15% of North American demand[12].

Pricing and Procurement Innovations

Dynamic pricing models now dominate API contracts. Shandong Octagon Chemicals employs machine learning algorithms to adjust quotes based on raw material futures, reducing price volatility by 18%[2][12]. Group purchasing organizations (GPOs) in Europe have negotiated tiered pricing with Intas Pharma, offering 5–7% discounts for annual commitments exceeding 500kg[12]. The 2025 introduction of India’s Production-Linked Incentive (PLI) scheme for APIs has enabled Lifecare Neuro to undercut Chinese suppliers by 9% while maintaining profitability[13].

Supply Chain and Logistics Considerations

Cold Chain Management for API Stability

Perampanel’s thermolabile nature (-20°C storage) requires specialized logistics. Catalent provides temperature-controlled “smart containers” with IoT sensors for transatlantic shipments, reducing thermal excursion incidents by 92%[11][12]. Tosun Pharmaceutical (China) partners with DHL’s Life Sciences division to maintain cold chain integrity across its 40-country distribution network, achieving a 99.4% on-time delivery rate in 2024[4][10].

Quality Assurance Protocols

Rigorous testing protocols differentiate premium suppliers. LGM Pharma performs quadrupole LC-MS analysis on every API batch, detecting impurities down to 0.01 ppm[7][12]. Lifecare Neuro’s in-house microbiology labs conduct sterility testing per USP <71>, with automated incubation systems cutting result times from 14 days to 72 hours[13]. The 2025 ICH Q13 guideline has prompted Jiangsu Nhwa to implement continuous manufacturing PAT systems, enabling real-time release of 30% of production lots[11][12].

Challenges in Perampanel Sourcing

Regulatory Harmonization Barriers

Divergent pharmacopeial standards complicate global sourcing. While Zhejiang Hengkang meets USP monographs for residual solvent limits (<500 ppm n-heptane), EU clients often require stricter adherence to EP’s <300 ppm threshold, necessitating dual production lines[2][12]. Brazil’s ANVISA continues to reject 22% of API shipments lacking Portuguese-language CoAs, a hurdle addressed by Metrochem API through certified translation services[5][12].

Raw Material Volatility

The pyridine derivatives market saw 34% price spikes in 2024 due to China’s export controls. Nuray Chemicals mitigated this through long-term contracts with BASF, securing 80% of its 2-chloropyridine needs at fixed rates until 2026[5][12]. Palladium catalyst shortages prompted Teva to develop a nickel-based cross-coupling alternative, reducing per-kg API production costs by $120[9][12].

Future Outlook and Strategic Recommendations

The Perampanel supplier market will likely consolidate around vertically integrated manufacturers offering end-to-end services from API synthesis to finished dosage forms. Partnerships with CDMOs like Lonza will prove critical for suppliers aiming to penetrate the $1.2 billion epilepsy biologics market projected for 2027[11][12]. Blockchain adoption for batch tracking, as piloted by Lifecare Neuro, may become industry-standard by 2026, reducing counterfeit risks in emerging markets[13].

"The future of Perampanel supply lies in adaptive manufacturing platforms that balance regulatory rigor with cost innovation." – HTF Market Intelligence, 2025 Global Perampanel API Report[12]

Key Takeaways

1. Asia-Pacific producers dominate volume, but Western suppliers lead in regulatory technology
2. Post-patent market fragmentation demands diversified supplier networks
3. Advanced analytics are reshaping pricing and quality assurance paradigms
4. Cold chain innovations remain critical for API integrity
5. Harmonized standards could unlock $420 million in annual efficiency gains

FAQs
Q: How do I verify a Perampanel supplier’s GMP compliance?
A: Require current FDA/EU inspection reports and review their latest ASMF/CEPs through regulatory databases[3][5].

Q: What percentage cost saving can generic suppliers offer?
A: Established generics providers like Teva offer 35–50% discounts versus originator pricing, depending on order volume[9][12].

Q: Which regions pose the highest regulatory risks?
A: Latin America and Southeast Asia require 23% more documentation rounds versus North America/Europe[12].

Q: How critical is DMF completeness for ANDA submissions?
A: 78% of FDA refusal actions cite incomplete stability data in referenced DMFs[3][7].

Q: What’s the lead time for EU-GMP certified API orders?
A: Average 14–18 weeks, reduced to 9 weeks with premium logistics partners[10][12].

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/perampanel
2. https://pharmaoffer.com/api-excipient-supplier/antiepileptics/perampanel
3. https://www.pharmacompass.com/active-pharmaceutical-ingredients/perampanel
4. https://www.chinadrugservices.com/active-pharmaceutical-ingredient/perampanel-api.html
5. https://www.pharmacompass.com/manufacturers-suppliers-exporters/perampanel-hydrate
6. https://www.indianpharmanetwork.in/fycompa-perampanel/
7. https://mms.mckesson.com/product/1256091/Catalyst-Pharmaceutical-69616027830
8. https://en.wikipedia.org/wiki/Perampanel
9. https://pharsight.greyb.com/ingredient/perampanel-patent-expiration
10. https://www.tosun-pharm.com/services/api-sourcing/
11. https://pmarketresearch.com/chemi/calcium-iodate-anhydrous-market/perampanel-api-market
12. https://www.htfmarketintelligence.com/report/global-perampanel-api-market
13. https://www.lifecare-neuro.com/blog/perampanel-tablets-manufacturer/

Last updated: 2025-04-18