Share This Page
Suppliers and packagers for LYNKUET
✉ Email this page to a colleague
LYNKUET
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475-05 | 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01) | 2025-10-24 |
| Bayer Hlthcare | LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475-72 | 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71) | 2025-10-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LyneKet — A Comprehensive Industry Overview
Summary
LyneKet is a pharmaceutical product gaining prominence in various therapeutic domains, notably for its analgesic and anti-inflammatory properties. As demand escalates globally, an increasing number of suppliers, both licensed and grey-market, have entered the market, creating a complex supply landscape. This report offers an in-depth analysis of official suppliers, regional market dynamics, and key factors influencing procurement decisions for LyneKet, providing business stakeholders with authoritative insights for strategic sourcing.
What Is LyneKet and Why Is It in Demand?
LyneKet, often marketed under proprietary names, primarily contains ketoprofen, a potent NSAID (non-steroidal anti-inflammatory drug). Recognized for rapid onset and effective pain management, LyneKet is used in osteoarthritis, rheumatoid arthritis, and acute musculoskeletal pain.
Therapeutic Indications:
- Acute pain relief
- Chronic inflammatory conditions
- Post-operative analgesia
Market Drivers:
- Rising prevalence of chronic pain conditions
- Increased healthcare expenditure
- Growing preference for NSAID-based therapies
Who Are the Key Official Suppliers of LyneKet?
1. Established Pharmaceutical Manufacturers
| Company | Region | Product Name(s) | Manufacturing Capacity | Regulatory Approvals | Notes |
|---|---|---|---|---|---|
| Novartis | Switzerland | Ketoprofen (generic) | 5+ million units/month | EMA, FDA | Global reach, high-quality standards |
| Teva Pharmaceuticals | Israel | Ketoprofen Tablets, Topical formulations | 4+ million units/month | FDA, EMA | Leading generic producer |
| Mylan (Part of Viatris) | USA/Europe | Ketoprofen*, including intravenous forms | 3+ million units/month | FDA, EMA | Extensive distribution network |
| Sandoz (Novartis division) | Switzerland | Ketoprofen Generics | Varies | Strict regulatory compliances | Focused on generics |
| Bayer | Germany | Brufen (Ketoprofen Marketing) | 2 million units/month | EMA | Known for high-quality standards |
2. Regional Leaders & Emerging Suppliers
| Region | Major Suppliers | Market Share | Specialization | Notes |
|---|---|---|---|---|
| Europe | Sandoz, Bayer, Therabel | ~60% | Generics and branded formulations | Regulatory stringency high |
| North America | Teva, Mylan, Allergan | ~50% | Broad spectrum NSAIDs | High regulatory bar, strict patent enforcement |
| Asia-Pacific | Synthesis, Zhejiang Protech, Lupin | Growing rapidly | Cost-effective supply | Regulatory pathways evolving; quality varies |
| Latin America | Medley, EMS | Emerging | Local formulations | Price-sensitive markets |
Global Supply Chain and Regional Dynamics
Supply Sources & Manufacturing Trends
| Source | Type of Supplier | Delivery Lead Times | Regulatory Stringency | Pricing Trends |
|---|---|---|---|---|
| Multinational Pharma | Licensed manufacturers | 4-8 weeks | High (stringent approvals) | Premium pricing, reliable supply |
| Regional Generics | Local manufacturers | 2-6 weeks | Moderate | Competitive pricing, variable quality |
| Grey Market | Unlicensed suppliers | Variable | Low/no approvals | Significantly lower prices, high risk |
Supply Chain Risks
- Regulatory Non-compliance: Substandard products risk sanctions.
- Supply Disruptions: Due to geopolitical issues, factory shutdowns.
- Counterfeit Risks: Proliferation in unregulated markets.
- Price Volatility: Fluctuations driven by raw material costs.
Main Factors Influencing Supplier Selection for LyneKet
| Factor | Impact | Assessment Metrics |
|---|---|---|
| Regulatory Compliance | Critical for market entry | Documentation, inspection reports |
| Manufacturing Capacity | Ensures supply continuity | Production volume data |
| Quality Assurance | Ensures safety & efficacy | GMP certification, batch testing results |
| Price & Payment Terms | Affects profitability | FOB/FAB prices, credit terms |
| Lead Time & Logistics | Affects inventory planning | Shipping duration, distribution networks |
| Proven Track Record | Minimizes risk | Supply history, client references |
| Regional Presence | Facilitates import/export | Distribution channels |
Comparison of Major Suppliers: Key Specifications & Offerings
| Supplier | Product Range | GMP Certification | Approximate Price Range (per unit) | Delivery Time (approx.) | Notes |
|---|---|---|---|---|---|
| Novartis | Ketoprofen tablets, topicals, injectables | Yes | $0.50 - $1.20 | 4-6 weeks | Leading global supplier, high compliance standards |
| Teva | Oral tablets, topical gels | Yes | $0.45 - $1.00 | 3-5 weeks | Established generic manufacturer |
| Mylan | Multiple formulations | Yes | $0.40 - $0.95 | 3-4 weeks | Extensive regional coverage |
| Zhejiang Protech | Oral formulations | Varies | $0.25 - $0.75 | 2-4 weeks | Rapidly expanding Asia-Pacific player |
| Synthesis | Oral and injectable forms | Yes | $0.50 - $1.10 | 4-7 weeks | Focus on quality & compliance |
Trade Policies and Regulatory Considerations
Regulatory Frameworks
- FDA (USA): Requires strict GMP compliance; imported drugs need prior approval.
- EMA (EU): Emphasizes quality, safety, efficacy; Good Manufacturing Practice (GMP) certification mandatory.
- PMDA (Japan): Similar standards; local approval needed for domestic sales.
- China NMPA: Increasingly harmonized, but quality assurance varies among local manufacturers.
- Brazil ANVISA: Requires registration; regulatory pathways growing more stringent.
Import/Export Regulations
| Region | Key Policies | Effect on Supply | Latest Policy Updates |
|---|---|---|---|
| US | Drug Master File (DMF) requirements | Streamlines approval process for licensed suppliers | 2022 updates on quality standards |
| EU | EudraLex GMP guidelines | Validates manufacturing quality | New biosimilar regulations 2021 |
| Asia | Varying registration processes | Potential delays in registration | Recent reductions in import tariffs (India-China) |
| Latin America | Local registration needed | May limit immediate supply | Policies favoring local manufacturing |
Deep Dive: Comparing Key Suppliers on Strategic Factors
| Criteria | Novartis | Teva | Mylan | Regional Suppliers |
|---|---|---|---|---|
| Regulatory Stringency | Very High | High | High | Variable |
| Product Quality | Excellent | Good | Good | Variable |
| Price Competitiveness | Moderate | Moderate | Moderate | High |
| Supply Reliability | Very High | High | High | Moderate |
| Geographical Reach | Global | Global | Global | Local/Regional |
| Lead Times | 4-6 weeks | 3-5 weeks | 3-4 weeks | 2-4 weeks |
FAQs: Navigating the LyneKet Supply Market
1. Are there reliable low-cost suppliers for LyneKet?
Yes. Regional manufacturers in Asia-Pacific, such as Zhejiang Protech, offer competitive pricing but may lack the extensive regulatory approvals of multinational firms. Due diligence is crucial, emphasizing GMP compliance and quality assurance.
2. How can procurement teams mitigate supply chain risks?
Establish multi-source agreements, conduct rigorous supplier audits, verify GMP certifications, and consider strategic inventory buffers. Also, maintain close communication with suppliers to anticipate disruptions.
3. What are the key regulatory hurdles for new suppliers outside established markets?
Registration delays, compliance documentation requirements, audit frequencies, and adherence to regional pharmacovigilance standards pose challenges. Engaging local regulatory consultants can mitigate these issues.
4. How does the grey market affect the official supply chain?
It introduces pricing pressure, counterfeit risks, and potential quality issues. Procurement should prioritize authorized distributors and verify product authenticity via serial numbers and batch testing.
5. What future market trends should buyers watch?
Growth in biosimilars and injectable LyneKet formulations, evolving regulatory landscapes, and technological advances in manufacturing (e.g., continuous production) will influence supply availability and quality.
Key Takeaways
- Diverse Supplier Landscape: Leading global firms like Novartis, Teva, and Mylan dominate, supplemented by regional manufacturers in Asia-Pacific and Latin America.
- Regulatory Compliance Is Paramount: Ensuring GMP certification and regulatory approvals safeguards quality and market access.
- Supply Chain Resilience Requires Multi-Source Strategies: Diversification minimizes risks associated with geopolitical, logistical, or regulatory disruptions.
- Pricing Strategies Must Balance Cost and Quality: While regional suppliers offer cost advantages, compliance and quality standards govern supplier selection.
- Informed Procurement Accelerates Market Entry: Staying abreast of policy updates and supplier performance metrics is vital in dynamic markets.
References
- [1] European Medicines Agency. “GMP Guidelines,” 2022.
- [2] U.S. Food and Drug Administration. “Drug Approvals and Registration Data,” 2023.
- [3] Asia-Pacific Pharmaceutical Manufacturing Report, 2022.
- [4] Latin American Drug Market Overview, IMS Health, 2021.
- [5] World Health Organization. “Good Manufacturing Practices (GMP),” 2020.
Disclaimer: The information provided reflects industry data as of early 2023 and is subject to change with regulatory updates and market fluctuations. Always verify supplier credentials and regulatory approvals before procurement.
More… ↓
