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Suppliers and packagers for generic pharmaceutical drug: ibuprofen lysine
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ibuprofen lysine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xgen Pharms | IBUPROFEN LYSINE | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 202402 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-1030-2 | 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) | 2016-04-08 |
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903 | NDA | Recordati Rare Diseases Inc. | 55292-122-52 | 3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL | 2006-04-13 |
| Recordati Rare | NEOPROFEN | ibuprofen lysine | INJECTABLE;INTRAVENOUS | 021903 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-490-36 | 3 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL | 2016-04-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ibuprofen Lysine
Introduction
Ibuprofen lysine represents a specialized formulation of the widely-used nonsteroidal anti-inflammatory drug (NSAID) ibuprofen. The lysine salt enhances solubility and bioavailability, allowing for rapid absorption and onset of action. Its applications span over-the-counter pain relief, reduction of inflammation, and management of various acute and chronic conditions. The global supply chain for ibuprofen lysine is diverse, involving multiple pharmaceutical manufacturers, raw material suppliers, and contract manufacturing organizations capable of producing high-quality, regulatory-compliant formulations.
This article provides an in-depth overview of primary suppliers involved in the manufacturing and distribution of ibuprofen lysine, exploring key considerations regarding quality standards, geographical distribution, and market dynamics crucial for stakeholders seeking to secure reliable sourcing.
Global Market for Ibuprofen Lysine: An Overview
The market for ibuprofen lysine is characterized by its niche positioning as an injectable or fast-absorbing formulation, often favored in hospital and acute care settings. The primary manufacturers and suppliers are located in regions with established pharmaceutical manufacturing infrastructure, notably Europe, Asia, and North America.
Major pharmaceutical companies involved in manufacturing ibuprofen lysine include international giants such as Schering-Plough (now part of Merck), Bayer, Reckitt Benckiser, and Avadel Pharmaceuticals. Key raw material suppliers supply the active pharmaceutical ingredient (API) and excipients, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards like those from the FDA and EMA.
Leading Suppliers of Ibuprofen Lysine API
1. Major API Manufacturers
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Bulk API Suppliers in China:
Chinese manufacturers lead the global API supply with companies such as Zhejiang Huashi Pharmaceutical and Hisoar Pharmaceutical. These suppliers offer ibuprofen lysine API with high purity and competitive pricing, often serving as contract manufacturers for global pharmaceutical companies. -
Indian API Producers:
India’s pharmaceutical sector includes companies like Divi's Laboratories and Aarti Drugs, which produce ibuprofen API and derivatives, including formulations incorporating lysine salts. They focus on quality certifications aligning with international standards. -
European API Manufacturers:
Firms such as BASF and Evonik Industries sometimes supply specialized pharmaceutical intermediates, including stable APIs with regulatory validations suitable for export to Western markets. Their offerings are typically distinguished by compliance and quality assurance.
2. Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource final formulations to CMOs with expertise in sterile and non-sterile injectables. Examples include:
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Fujifilm Diosynth Biotechnologies: Known for contract manufacturing in injectables and sterile powders, capable of producing ibuprofen lysine formulations at scale with rigorous quality controls.
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Recipharm: Provides cGMP manufacturing platforms, including liquid and lyophilized forms of ibuprofen lysine.
Suppliers of Excipients and Other Raw Materials
Reliable supply of high-quality excipients—such as lysine salts, stabilizers, and solvents—is critical for product stability and efficacy.
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Lubrizol and Ashland serve as key excipient suppliers, offering pharmaceutical-grade lysine compatible with higher bioavailability formulations.
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Sigma-Aldrich (Merck Group) supplies pharmaceutical-grade solvents and reagents necessary for manufacturing processes.
Supply Chain Considerations
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Regulatory Compliance:
Suppliers must adhere to GMP standards, with certifications such as FDA approval or EMA certification, ensuring product safety, efficacy, and quality. -
Quality Control and Certifications:
ISO 9001, GMP compliance, and pharmacopoeia adherence (USP, EP, JP) are crucial benchmarks. -
Lead Times and Capacity:
Given the growth in demand driven by acute care and hospital use, capacity constraints can impact supply reliability. Establishing alliances with multiple suppliers mitigates risks. -
Pricing Dynamics:
Market competition among Chinese and Indian API producers sustains cost-effectiveness, but quality and regulatory status often influence procurement decisions.
Notable Regional Suppliers
| Region | Key Suppliers | Notable Features |
|---|---|---|
| China | Zhejiang Huashi Pharmaceutical, Hisoar Pharmaceutical | Cost-effective, large capacity, evolving quality standards |
| India | Divi’s Laboratories, Aarti Drugs | High regulatory standards, consistent quality |
| Europe | BASF, Evonik | Specialty chemicals, high compliance standards |
| North America | Merck, Pfizer (via licensing/Partnerships) | Regulatory oversight, quality assurance |
Market Trends and Supply Chain Challenges
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Supply Chain Disruptions: The COVID-19 pandemic highlighted vulnerabilities, such as delays in raw material procurement and production bottlenecks. Strengthening supplier relationships and diversifying sourcing have become strategic priorities.
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Regulatory Shift and Compliance: Increasing regulatory scrutiny emphasizes supplier certifications, transparency, and traceability in the supply chain.
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Emerging Markets: Countries like Vietnam and Malaysia are expanding manufacturing capabilities, potentially offering alternative suppliers for ibuprofen lysine.
Conclusion
The procurement of ibuprofen lysine requires a strategic approach focusing on quality, regulatory compliance, and supply chain resilience. Leading suppliers span China, India, Europe, and North America, each with unique offerings driven by capacity, cost, and quality standards.
Businesses must evaluate suppliers based on GMP certification, regulatory track record, and capacity to meet demand fluctuations. Establishing partnerships across multiple suppliers can mitigate risks, ensure consistent supply, and support global market expansion.
Key Takeaways
- Diversify supplier base: Rely on multiple reputable manufacturers across different regions to mitigate supply disruption risks.
- Prioritize quality and compliance: Ensure suppliers hold necessary GMP, FDA, EMA, and pharmacopoeia certifications.
- Engage with contract manufacturers: For specialized formulations like injectable ibuprofen lysine, collaborate with CMOs experienced in sterile manufacturing.
- Monitor market dynamics: Stay informed about geopolitical, regulatory, and logistical shifts affecting supply chains.
- Build strategic relationships: Long-term partnerships with reliable suppliers secure cost-effective, high-quality sourcing.
FAQs
1. Who are the top global suppliers of ibuprofen lysine API?
Chinese companies such as Zhejiang Huashi Pharmaceutical and Indian firms like Divi’s Laboratories lead in API production, offering cost-effective solutions with increasing regulatory compliance.
2. Can ibuprofen lysine be sourced from multiple regions to ensure supply security?
Yes. Diversification across regions like China, India, and Europe minimizes risks related to regional disruptions and enhances supply chain resilience.
3. What regulatory certifications should suppliers of ibuprofen lysine possess?
Suppliers should hold GMP certification, and if exporting to specific markets, FDA approval (U.S.) or EMA certification (Europe). Pharmacopoeia adherence (USP, EP, JP) is also essential.
4. Are there specialized contract manufacturers for ibuprofen lysine formulations?
Yes. Companies such as Fujifilm Diosynth and Recipharm have capabilities to produce sterile and non-sterile injectable formulations, including ibuprofen lysine.
5. How do market trends impact the sourcing of ibuprofen lysine?
Increased demand in hospitals and acute care drives procurement, while supply chain disruptions necessitate strategic supplier partnerships and diversification for reliable sourcing.
References
[1] Market insights into ibuprofen formulations, Global Data, 2022.
[2] GMP standards and pharmaceutical supply chain, WHO Guidelines, 2021.
[3] API manufacturing landscape in China and India, PharmaIntelligence, 2022.
[4] Contract manufacturing capabilities for sterile drugs, PharmaIQ, 2023.
[5] Regulatory considerations in pharmaceutical ingredient sourcing, FDA, EMA, 2023.
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