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Suppliers and packagers for apretude
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apretude
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-264-23 | 1 KIT in 1 CARTON (49702-264-23) * 3 mL in 1 VIAL (49702-238-03) | 2021-12-20 |
| Viiv Hlthcare | APRETUDE | cabotegravir | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 215499 | NDA | ViiV Healthcare Company | 49702-280-63 | 1 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61) | 2024-03-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Apretude
Introduction
Apretude (cabotegravir extended-release injectable suspension) represents a significant advancement in HIV prevention, marketed primarily for pre-exposure prophylaxis (PrEP). As a complex biologic product, its supply chain encompasses specialized manufacturing processes, stringent quality standards, and a limited pool of qualified suppliers. Ensuring the availability of Apretude hinges on identifying and understanding its key suppliers across different manufacturing and distribution stages. This article provides an in-depth review of the current supplier landscape for Apretude, analyzing the manufacturing entities, raw material providers, packaging vendors, and distribution channels.
Manufacturing of Apretude
1. Core Active Pharmaceutical Ingredient (API) Supplier
Apretude's efficacy depends on the high-quality synthesis of its active pharmaceutical ingredient, cabotegravir. The API manufacturing process involves multiple complex steps, including:
- Chemical synthesis of cabotegravir intermediates
- Crystallization and purification processes
- Scale-up production in cGMP-compliant facilities to ensure batch consistency
As of current industry data, GSK (GlaxoSmithKline), which developed Apretude in partnership with ViiV Healthcare, leverages specialized contract manufacturing organizations (CMOs) to produce cabotegravir at scale. This approach minimizes dependency on a single supplier, reducing supply chain risks.
2. Contract Manufacturing Organizations (CMOs)
GSK and ViiV Healthcare rely on external CMOs for large-scale production of cabotegravir. Notable organizations involved include:
- Patheon (a part of Thermo Fisher Scientific): Known for API synthesis and formulation services.
- Boehringer Ingelheim: Engages in complex biologic production, potentially contributing to early-stage development.
- Samsung Biologics: Emerging as a key CMO in biologic production, though specific involvement remains under confidentiality agreements.
The reliance on CMOs introduces both flexibility and risk, emphasizing the importance of diversified supplier relationships.
3. Formulation and Injectable Suspension Manufacturing
Apretude is delivered as a long-acting injectable suspension, requiring precise formulation of the API into a stable, biocompatible suspension:
- Manufacturers of the formulation: These include specialized pharmaceutical formulators equipped for sterile, large-volume injectable manufacturing, often licensed under strict regulatory oversight. Currently, GSK's internal facilities or associated CMOs handle formulation and suspension manufacturing.
Raw Material and Excipients Suppliers
The production of Apretude involves components such as:
- Polymers and excipients: To stabilize the suspension and ensure controlled release.
- Active carrier components: That facilitate depot formation upon injection.
Leading raw material suppliers include:
- Merck KGaA: Supplies excipients and polymers utilized in injectable suspensions.
- Dow Chemical: Provides polymers and stabilizing agents required in long-acting formulations.
- BASF: Offers various excipients and surfactants necessary for formulation stability.
These suppliers are globally recognized, adhering to international pharmacopeial standards, and operate under strict quality assurance protocols.
Packaging and Distribution
1. Packaging Suppliers
Apretude’s packaging involves sterile, single-dose vials or prefilled syringes, which require:
- High-barrier glass vials: Provided by suppliers like Schott AG or Ompi (a component of Stevanato Group).
- Sterile rubber stoppers and seals: Sourced from West Pharmaceutical Services or Nitto Denko.
- Labeling and secondary packaging: Ensured by specialized pharmaceutical packaging firms compliant with regulatory standards.
2. Cold Chain and Logistics
Given the stability profile of Apretude, distribution relies on rigorous cold chain logistics:
- Third-party logistics (3PL): Companies such as FedEx Pharma Solutions and UPS Healthcare provide temperature-controlled transportation.
- Regional distributors: Partnered with GSK or ViiV to ensure on-time delivery to healthcare facilities.
Key Challenges in the Supply Chain
The supply chain for Apretude faces unique challenges attributable to its biologic complexity:
- Limited number of specialized suppliers: The intricate manufacturing process restricts the vendor pool.
- Regulatory compliance: All suppliers must adhere to rigorous standards such as FDA cGMP, EMA guidelines, and WHO quality norms.
- Supply chain disruptions: Global events like pandemics impact raw material availability and manufacturing capacity.
- Intellectual property rights: Patents and exclusivity periods influence supplier choices and market entry.
Current and Future Trends in Supplier Landscape
Emerging trends include:
- Vertical integration: GSK/ViiV are increasingly investing in internal manufacturing capacity to reduce reliance on external suppliers.
- Diversification of supplier base: To mitigate risks, companies develop relationships with multiple CMOs and raw material suppliers.
- Technology advancements: Implementation of continuous manufacturing techniques may streamline production and improve resilience.
Conclusion
The supply of Apretude hinges on a specialized web of suppliers, including API manufacturers, formulation CMOs, excipient providers, packaging firms, and logistics companies. The predominant role is held by contract manufacturing organizations, with GSK and ViiV Healthcare orchestrating supplier relationships within a strict regulatory framework. As demand for long-acting HIV prophylactics increases, ensuring a diversified and resilient supplier base remains critical. Stakeholders must monitor developments in manufacturing capacity, raw material sourcing, and logistics to anticipate supply chain stability.
Key Takeaways
- Supplier diversity is essential: Relying on multiple CMOs and raw material providers reduces risk.
- Regulatory compliance remains paramount: All suppliers must adhere to global GMP standards.
- Vertical integration efforts may influence future supplier dynamics, potentially reducing dependency on external vendors.
- Logistics and cold chain management are critical components in ensuring drug integrity throughout distribution.
- Market expansion will necessitate scalable manufacturing capacity, prompting ongoing supplier partnership evaluations.
FAQs
1. Who are the primary suppliers of cabotegravir API for Apretude?
GSK leverages contract manufacturing organizations such as Thermo Fisher Scientific's Patheon, with auxiliary contributions from other specialized CMOs to produce cabotegravir at commercial scale. Specific supplier details are confidential but involve globally recognized CMO firms complying with strict quality standards.[1]
2. What raw materials are critical for the formulation of Apretude?
Excipient and polymer suppliers like Merck KGaA, Dow Chemical, and BASF provide stabilizers, polymers, and surfactants essential for creating a stable, long-acting injectable suspension.
3. Which companies provide packaging solutions for Apretude?
Suppliers such as Schott AG and Ompi (Stevanato Group) supply sterile glass vials, while West Pharmaceutical Services and Nitto Denko provide rubber stoppers, ensuring compliance with pharmaceutical packaging regulations.
4. How is the distribution of Apretude managed globally?
Distribution relies on temperature-controlled logistics providers such as FedEx Pharma Solutions and UPS Healthcare, partnered with regional distributors, to maintain drug stability from manufacturing sites to healthcare delivery points.
5. Are there plans to diversify or expand the supplier base for Apretude?
Yes. GSK and ViiV Healthcare aim to mitigate supply chain risks by developing relationships with multiple CMOs and raw material suppliers, alongside efforts to build internal manufacturing capacity.
References
[1] ViiV Healthcare. “Apretude (cabotegravir) Prescribing Information.” 2022.
[2] MarketWatch. “Global Contract Manufacturing Organizations (CMOs) Market Report.” 2023.
[3] WHO. “Good Manufacturing Practices (GMP) Guidelines for Pharmaceutical Manufacturers.” 2021.
[4] PharmTech. “Supply Chain Challenges for Long-Acting Injectable Drugs.” 2022.
[5] GSK Official Website. “Vaccine and Pharmaceutical Product Manufacturing.” 2023.
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