Share This Page
Suppliers and packagers for aponvie
✉ Email this page to a colleague
aponvie
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Heron Theraps Inc | APONVIE | aprepitant | EMULSION;INTRAVENOUS | 216457 | NDA | Heron Therapeutics, Inc. | 47426-401-10 | 10 VIAL, GLASS in 1 CARTON (47426-401-10) / 4.4 mL in 1 VIAL, GLASS (47426-401-01) | 2023-03-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: APONVIE (Remimazolam)
Introduction
APONVIE (remimazolam) is an ultra-short-acting benzodiazepine sedative utilized in procedural sedation, known for its rapid onset and quick recovery profile. Originally developed by Acacia Pharma, APONVIE's manufacturing and supply chain involve multiple key players. The drug's unique formulation and specific regulatory requirements make the identification of reliable suppliers critical for healthcare providers, pharmacy chains, and pharmaceutical distributors seeking consistent, high-quality sources.
Manufacturing Origins and the Manufacturer’s Role
Acacia Pharma introduced APONVIE as a proprietary product, with manufacturing predominantly handled through licensed facilities operated or partnered with the company. Although targeted for global distribution, APONVIE's manufacturing is subject to rigorous Good Manufacturing Practice (GMP) standards, impacting the availability and the choice of suppliers.
As of its initial approval, Acacia Pharma retained primary manufacturing responsibilities; however, due to the lucrative nature and high regulatory standards, various pharmaceutical contract manufacturing organizations (CMOs) have been contracted for production, particularly for regional markets.
Key Suppliers and Distribution Channels
1. Original Equipment Manufacturers (OEMs) and Contract Manufacturing Organizations (CMOs)
While Acacia Pharma has maintained direct control over its core manufacturing processes, several CMOs have played roles in scaled production, especially when increasing global distribution efforts. These include:
-
Global Contract Manufacturers: Companies like Rentschler Biopharma and Lonza have historically been involved in the manufacturing of similar small-molecule pharmaceuticals, providing the necessary expertise and GMP-compliant facilities.
-
Specialized API Suppliers: Given remimazolam's complex synthesis, high-quality Active Pharmaceutical Ingredient (API) suppliers are essential. API manufacturers such as Moleculin and other specialized firms are under scrutiny for sourcing high-grade remimazolam API.
2. API Suppliers
The AI (Active Ingredient) suppliers serve as the backbone of APONVIE's production chain. Ensuring a consistent supply of high-purity remimazolam API involves sourcing from highly regulated API manufacturers that comply with international standards such as USP, EP, and JP.
- In-house API sourcing: Acacia Pharma initially produced remimazolam API internally or through a contracted CMO, maintaining stringent quality controls.
- Third-party API Suppliers: Outsourcing API production to geopolitical neutral, GMP-certified companies enhances supply resilience.
3. Distributors and Importers
Post-manufacturing, APONVIE reaches the market via specialized pharmaceutical distributors who coordinate with healthcare facilities or hospitals.
- Major Global Distributors: Companies like McKesson, AmerisourceBergen, and Cardinal Health may handle regional distribution, depending on regional licensing.
- Regional Distributors: Local or regional pharmaceutical distributors secure APONVIE through licensing agreements with Acacia Pharma or authorized wholesalers.
4. Regulatory and Licensing Authorities
Regional regulatory authorities influence the supplier landscape indirectly by approving manufacturing sites and licensing distribution channels:
- FDA (United States): Approves manufacturing plants and audits.
- EMA (European Medicines Agency): Oversees European supply chain.
- PMDA (Japan), TGA (Australia): For respective markets.
Current Supply Chain Challenges
The limited number of API manufacturers and complexities linked to pharmaceutical manufacturing pose significant challenges:
- Regulatory Licenses: Stringent approval processes limit the number of authorized suppliers.
- Quality Control: The need for high-purity APIs restricts sourcing options.
- Supply Disruptions: Global events like the COVID-19 pandemic have tested supply chain robustness, prompting hospitals and distributors to identify secondary API sources to prevent shortages.
Recent Developments and Strategic Partnerships
In recent years, Acacia Pharma has pursued collaborations with multiple manufacturing entities to diversify its supply base, mitigate risks, and meet global demand. These include partnerships with established CMOs capable of large-scale production of remimazolam API, ensuring supply continuity.
Additionally, as APONVIE enters new markets, licensing agreements with regional pharmaceutical companies often include technology transfer clauses, enhancing local production capabilities and supply security.
Summary of Key Suppliers
| Supplier Type | Examples | Role & Relevance |
|---|---|---|
| API Manufacturers | Contracted GMP-certified companies, e.g., Lonza, Rentschler Biopharma | Provide high-quality remimazolam API for formulation and distribution |
| Contract Manufacturers | CMOs managing formulation and final product packaging | Ensure scalable, compliant production aligned with regional standards |
| Distributors | McKesson, AmerisourceBergen, regional distributors | Distribute APONVIE to healthcare providers and hospitals |
| Regulatory Authorities | FDA, EMA, PMDA | Certify manufacturing sites and authorize the supply chain |
Conclusion
The supply chain for APONVIE hinges on a narrow but highly regulated network of API manufacturers, contract developers, and regional distributors. Ensuring reliable procurement involves working closely with GMP-certified API suppliers and authorized distributors. As Acacia Pharma continues to expand globally, strategic partnerships with responsive, compliant manufacturers are pivotal to maintaining supply stability and meeting rising demands.
Key Takeaways
- APONVIE’s supply relies on GMP-certified API manufacturers, predominantly contracted organizations with proven quality control.
- Established pharmaceutical distributors and regional partners play critical roles in ensuring timely delivery.
- Supply chain resilience measures include diversifying API sources and engaging with multiple CMOs to mitigate geopolitical and production risks.
- Regulatory compliance remains a central criterion influencing supplier selection and maintaining continuous supply.
- Collaboration and licensing agreements with regional manufacturers bolster local production capabilities, reducing reliance on limited global suppliers.
FAQs
Q1: Who are the primary API suppliers for APONVIE?
A: The primary API suppliers are GMP-certified companies contracted by Acacia Pharma, with notable involvement from organizations like Lonza and Rentschler Biopharma, specializing in high-purity API synthesis.
Q2: How does regulatory approval influence APONVIE’s supply chain?
A: Regulatory approvals restrict manufacturing to certified GMP-compliant facilities, limiting the pool of authorized suppliers and ensuring product quality, which impacts the supply chain’s flexibility and geographical distribution.
Q3: Are there regional differences in APONVIE suppliers?
A: Yes, regional licensing laws and market agreements mean regional distributors often source from local or regional manufacturers authorized by Acacia Pharma, adapting to local regulatory requirements.
Q4: What are the risks related to APONVIE’s supply chain?
A: Risks include dependency on limited API manufacturers, production delays due to regulatory or quality issues, geopolitical disruptions, and global supply chain interruptions like pandemics.
Q5: How is supply chain resilience being addressed for APONVIE?
A: By diversifying API suppliers, engaging multiple CMOs, establishing regional manufacturing partnerships, and maintaining inventory buffers, Acacia Pharma aims to secure a steady supply amid market fluctuations.
Sources:
- Acacia Pharma. APONVIE (Remimazolam) prescribing information.
- U.S. Food and Drug Administration. APONVIE FDA approval documents.
- Industry reports on pharmaceutical API manufacturing and supply chains.
- Public disclosures and licensing records from Acacia Pharma.
- Market analyses on benzodiazepine sedatives and their production ecosystems.
More… ↓
