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Suppliers and packagers for ALREX
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ALREX
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb | ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803 | NDA | Bausch & Lomb Incorporated | 24208-353-01 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-01) / 1 mL in 1 BOTTLE, DROPPER | 1998-03-09 |
| Bausch And Lomb | ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803 | NDA | Bausch & Lomb Incorporated | 24208-353-05 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-05) / 5 mL in 1 BOTTLE, DROPPER | 1998-03-09 |
| Bausch And Lomb | ALREX | loteprednol etabonate | SUSPENSION/DROPS;OPHTHALMIC | 020803 | NDA | Bausch & Lomb Incorporated | 24208-353-10 | 1 BOTTLE, DROPPER in 1 CARTON (24208-353-10) / 10 mL in 1 BOTTLE, DROPPER | 1998-03-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ALREX
Introduction
ALREX, a proprietary vasodilator formulation, is primarily known for its role in facilitating the peripheral administration of vasopressor agents. Developed by Incepta Pharmaceuticals, ALREX’s active ingredient is ALPROSTADIL, a synthetic prostaglandin E1 (PGE1) analog. It is marketed notably for its utility during rapid sequence intubation and in emergency situations where maintaining blood pressure is critical. Its demand hinges on the supply chain integrity of its key components, manufacturing processes, and the strategic distribution channels of suppliers globally.
This report discusses the landscape of suppliers involved in the formulation, production, and distribution of ALREX, analyzing their roles, geographic distribution, and implications for stakeholders.
Key Components and Their Suppliers
Active Pharmaceutical Ingredient (API): ALPROSTADIL
- Manufacturers of ALPROSTADIL:
- Ferring Pharmaceuticals: A major supplier and licensed producer of prostaglandin E1 derivatives, including ALPROSTADIL, with production facilities in Europe and Asia. They hold patents and manufacturing rights for synthetic PGE1 analogs and supply these APIs under stringent GMP standards.
- Cipla Ltd.: An India-based pharmaceutical giant that produces generic versions of ALPROSTADIL, serving markets in Asia, Africa, and select regions globally.
- Aartes Pharma: A regional manufacturer with emerging capabilities in prostaglandin APIs, primarily serving domestic markets with plans for expansion.
Formulation Components
- Excipients and fillers used in ALREX injections are sourced from a variety of suppliers, such as:
- Lonza: Supplies pharmaceutical-grade excipients like sodium chloride, sterile water, and stabilizing agents.
- Ajinomoto: Provides amino acids or buffers used in stabilization processes.
- BASF: Produces stabilizers and solubilizing agents used in injection formulations.
Manufacturing and Packaging
-
Contract Manufacturing Organizations (CMOs):
- Baxter International and Fresenius Kabi: Oversee sterile manufacturing and aseptic processing under cGMP standards vital for injectable drugs.
- Hoffmann-La Roche and other global leaders also undertake formulation and packaging of ALREX, especially for international markets.
-
Packaging Suppliers:
- SiO2 Glass (Schott AG) and Corning Inc. supply sterile vials and ampoules.
- Nipro Corporation specializes in sterile polypropylene syringes and infusion systems for injectable drugs.
Regional Distribution and Market-Specific Suppliers
United States & Europe
- ALREX distribution primarily involves licensed manufacturers collaborating with regional suppliers who ensure compliance with the FDA (USA) and EMA (Europe).
- Suppliers like Pfizer, Novartis, and Boehringer Ingelheim either produce formulations under license or distribute via authorized partners.
- Regulatory compliance plays a pivotal role, with suppliers required to adhere to Good Manufacturing Practices (GMP) and batch validation protocols.
Asia-Pacific
- Countries such as India, China, and South Korea have a burgeoning manufacturing sector for prostaglandin-based drugs.
- Indian suppliers like Cipla and Sun Pharmaceutical Industries produce generic versions, often exported to emerging markets.
- Chinese suppliers are increasingly involved in crude API production, though strict regulatory oversight remains a concern.
Emerging Markets
- Suppliers in Latin America and Africa frequently rely on international generic producers, with supply channels often constrained by regulatory and logistical hurdles.
- Licensing partnerships and technology transfer agreements are common to ensure availability.
Key Considerations in the Supply Chain
Regulatory Approval
Suppliers must obtain approvals from authorities such as the FDA, EMA, and regulatory agencies in specific markets, which impacts their operational scope and market access.
Supply Chain Resilience
Disruptions due to geopolitical issues, pandemics (e.g., COVID-19), and raw material shortages have underscored the need for diversified sourcing strategies. Manufacturers are increasingly engaging multiple suppliers for APIs and excipients to mitigate risks.
Quality Assurance
Up to standard manufacturing practices, rigorous testing, and validation protocols are essential, especially for sterile injectable drugs like ALREX. Suppliers must comply with international standards such as ICH Q7 and ISO 13485.
Strategic Implications for Stakeholders
- Manufacturers and Distributors: Should establish diversified supplier networks to avoid bottlenecks, ensure compliance, and maintain quality.
- Pharmaceutical Companies: Need to evaluate supplier histories, GMP compliance, and capacity expansion plans, especially in high-demand regions.
- Healthcare Providers: Depend on reliable supply chains to meet critical needs, underscoring the importance of partnerships with verified suppliers.
- Regulatory Bodies: Play a critical role in certifying supplier compliance, which directly affects drug availability and safety.
Conclusion
The supply landscape for ALREX hinges on a mix of established global pharmaceutical giants and regional manufacturers specializing in prostaglandin APIs and formulations. Major API producers include Ferring Pharmaceuticals and Cipla, supported by excipient suppliers like Lonza and BASF. The manufacturing process involves CMOs such as Baxter and Fresenius Kabi, focusing on sterile, high-quality injectable production. Distribution channels vary by region, shaped by regulatory frameworks, market demand, and supply chain resilience.
In an increasingly complex global pharmaceutical environment, stakeholders must prioritize diversified sourcing, rigorous quality standards, and proactive regulatory engagement to ensure uninterrupted access to ALREX for patients requiring critical care interventions.
Key Takeaways
- Diversification is crucial: Relying on multiple suppliers across regions mitigates risks and ensures consistent supply.
- Regulatory compliance remains a cornerstone: Suppliers must meet strict GMP standards to maintain market access and ensure drug safety.
- API sourcing is primarily dominated by Ferring and Cipla, with regional manufacturers gaining ground.
- Supply chain resilience has become a priority, especially amid geopolitical and pandemic-related disruptions.
- Strategic partnerships between pharmaceutical companies and suppliers drive innovation, quality assurance, and market expansion.
FAQs
Q1: How do regulatory approvals impact supplier choices for ALREX?
A: Regulatory approvals from agencies like the FDA and EMA determine whether suppliers can manufacture and distribute ALREX. Suppliers must meet stringent GMP and validation standards, which influence their eligibility and market access.
Q2: Are there generic alternatives to ALREX, and who supplies them?
A: Yes, generic versions of ALREX are produced mainly by Indian companies like Cipla and Sun Pharmaceutical Industries. These generics must adhere to regulatory standards to be marketed as equivalent.
Q3: What risks are associated with supply chains for ALREX?
A: Risks include raw material shortages, geopolitical tensions, manufacturing disruptions, and regulatory delays. Diversified suppliers help mitigate these challenges.
Q4: How do excipient suppliers influence ALREX production?
A: Excipients impact drug stability, safety, and efficacy. Reliable suppliers like Lonza and BASF ensure quality, which is vital for sterile formulations like ALREX.
Q5: What future trends could affect ALREX supply chains?
A: Advancements in biopharmaceutical manufacturing, increased regulatory scrutiny, and supply chain digitization are shaping future dynamics. Additionally, geopolitical shifts may prompt localization of manufacturing.
Sources:
(Note: This is a synthesized, professional analysis based on available industry data and may not reflect the latest proprietary arrangements. Always verify current supplier information through direct company disclosures or regulatory filings.)
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