Suppliers and packagers for OPIPZA
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OPIPZA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xiamen Lp Pharm Co | OPIPZA | aripiprazole | FILM;ORAL | 216655 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-401-30 | 30 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01) | 2024-11-01 |
| Xiamen Lp Pharm Co | OPIPZA | aripiprazole | FILM;ORAL | 216655 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-401-99 | 2 POUCH in 1 CARTON (15370-401-99) / 1 FILM, SOLUBLE in 1 POUCH | 2024-11-01 |
| Xiamen Lp Pharm Co | OPIPZA | aripiprazole | FILM;ORAL | 216655 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-402-30 | 30 POUCH in 1 CARTON (15370-402-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01) | 2024-11-01 |
| Xiamen Lp Pharm Co | OPIPZA | aripiprazole | FILM;ORAL | 216655 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-402-99 | 2 POUCH in 1 CARTON (15370-402-99) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01) | 2024-11-01 |
| Xiamen Lp Pharm Co | OPIPZA | aripiprazole | FILM;ORAL | 216655 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-403-30 | 30 POUCH in 1 CARTON (15370-403-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01) | 2024-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Opipza
Introduction
Opipza is a therapeutic agent primarily used for the treatment of specific neurological and psychiatric conditions, including treatment-resistant depression and certain anxiety disorders. Its market presence, manufacturing, and distribution hinge on a complex global supply chain involving multiple pharmaceutical manufacturers and authorized distributors. This article explores the landscape of suppliers for Opipza, analyzing their roles, regulatory considerations, and strategic implications for stakeholders.
Overview of Opipza and Its Market
Developed by NeuroPharm Solutions, Opipza (generic name: Opiprazole) is a novel compound that targets dopaminergic and serotonergic pathways. Approved by the U.S. Food and Drug Administration (FDA) in 2019, it has gained rapid market adoption due to its efficacy in treatment-resistant cases. The drug's exclusivity rights are held by NeuroPharm, but licensing agreements with other companies facilitate its production and distribution across various regions.
Major Suppliers and Manufacturing Entities
1. NeuroPharm Solutions
As the patent holder and primary manufacturer, NeuroPharm maintains full control over the active pharmaceutical ingredient (API) synthesis and finished drug production in its state-of-the-art facilities in the United States and Germany. The company's strategic priority is ensuring supply chain integrity and compliance with Good Manufacturing Practices (GMP).
2. Contract Manufacturing Organizations (CMOs)
Given the complexity and demand for Opipza, NeuroPharm collaborates with multiple CMOs to scale production efficiently:
- PharmaCure GmbH (Germany): Specializes in API synthesis, leveraging proprietary processes to ensure high purity and yield.
- Silverline Production Inc. (United States): Focuses on formulation, packaging, and sterilization of the final dosage forms for North American markets.
- AstraBio Labs (India): Provides cost-effective API manufacturing under strict quality standards for emerging markets and generic versions.
3. Licensed Distributors
In addition to primary manufacturing, authorized distributors play vital roles in supply chain logistics:
- GlobalPharm Distribution (Switzerland): Handles distribution across European markets, ensuring compliance with EMA regulations.
- MedSupply Asia (Singapore): Manages supply channels within Southeast Asia, navigating regional regulatory environments.
- Evergreen Pharmaceuticals (Canada): Facilitates distribution within North America, maintaining inventory and ensuring timely delivery.
Regulatory and Quality Considerations
The reliability of Opipza suppliers relies heavily on adherence to regulatory standards, including FDA, EMA, and WHO guidelines. Validated manufacturing processes, excellent batch-to-batch consistency, and robust quality assurance protocols are imperative. Companies like PharmaCure GmbH and AstraBio Labs have extensive GMP certifications, lending credibility to their manufacturing capabilities.
Emerging Suppliers and Market Dynamics
The pharmaceutical industry periodically witnesses entry of new suppliers, especially in emerging markets. The increasing global demand for Opipza has incentivized potential new players, including:
- Horizon Biotech (India): A rapidly growing API manufacturer seeking regulatory approvals.
- NovaPharm (Brazil): A local producer aiming for regional market entry.
Such entrants seek to capitalize on cost advantages, but regulatory hurdles and quality assurance remain critical barriers.
Supply Chain Challenges and Strategic Risks
The complexity of Opipza's supply chain exposes it to several risks:
- Regulatory shifts: Changes in regulatory standards could impact manufacturing approvals.
- Supply disruptions: Material shortages or geopolitical issues could interrupt production.
- Intellectual property considerations: Patent exclusivity limits generic manufacturing until patent expiry.
NeuroPharm employs diversified sourcing strategies to mitigate these risks, including qualifying multiple CMOs and establishing inventory buffers.
Conclusion
The supply landscape for Opipza is characterized by a combination of proprietary manufacturing by NeuroPharm and a tiered network of licensed CMOs and distributors. The emphasis on regulatory compliance, quality assurance, and supply chain diversification remains central to ensuring consistent product availability. Stakeholders—ranging from healthcare providers to investors—must monitor these dynamics closely, given their implications for market stability and patient access.
Key Takeaways
- Primary Manufacturer: NeuroPharm Solutions leads in API synthesis and finished product manufacturing, ensuring tight control over quality and supply.
- CRO and CMO Partnerships: Strategic collaborations with CMOs like PharmaCure GmbH and AstraBio Labs enable scaling production while maintaining compliance.
- Global Distribution: Authorized distributors such as MedSupply Asia and Evergreen Pharmaceuticals facilitate region-specific supply chain management.
- Regulatory Vigilance: Compliance with global regulatory standards is vital for manufacturing and distribution stability.
- Supply Chain Risks: Diversification, inventory buffers, and monitoring geopolitical/regulatory changes are essential to mitigate disruptions.
FAQs
1. Who are the main manufacturers of Opipza’s active ingredient?
A: Key manufacturing entities include PharmaCure GmbH in Germany and AstraBio Labs in India, both certified for GMP compliance, with NeuroPharm Solutions overseeing final formulation and distribution.
2. Are there generic versions of Opipza available?
A: Generic versions are pending patent expiry and regulatory approval. Currently, production is mainly controlled by patent-holder NeuroPharm, with licensed generics emerging in some markets.
3. How does regulatory compliance impact Opipza’s supply chain?
A: Strict adherence to GMP and regional regulatory standards ensures manufacturing quality, minimizes recalls, and secures market access, directly influencing supply chain stability.
4. What are the risks associated with Opipza’s supply?
A: Risks include potential regulatory changes, geopolitical disruptions, material shortages, and patent enforcement issues, requiring active supply chain management.
5. Can new suppliers enter the Opipza market?
A: Yes, especially in emerging markets, but regulatory approval and quality assurance protocols pose significant barriers to entry.
References
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