Share This Page
Suppliers and packagers for truqap
✉ Email this page to a colleague
truqap
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | TRUQAP | capivasertib | TABLET;ORAL | 218197 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9500-01 | 64 TABLET, FILM COATED in 1 BOTTLE (0310-9500-01) | 2023-11-16 |
| Astrazeneca | TRUQAP | capivasertib | TABLET;ORAL | 218197 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9500-02 | 4 BLISTER PACK in 1 CARTON (0310-9500-02) / 16 TABLET, FILM COATED in 1 BLISTER PACK | 2023-11-16 |
| Astrazeneca | TRUQAP | capivasertib | TABLET;ORAL | 218197 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9501-01 | 64 TABLET, FILM COATED in 1 BOTTLE (0310-9501-01) | 2023-11-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TRUQAP
Introduction
The pharmaceutical landscape is characterized by complex supply chains that require strict adherence to regulatory standards, quality controls, and intellectual property protections. TRUQAP, a medication designed for specialized therapeutic use—presumably in areas such as oncology, neurology, or infectious diseases—has garnered attention in recent years. Its supply chain hinges on reliable suppliers capable of meeting regulatory compliance, ensuring consistent product quality, and supporting global distribution demands. This report examines key suppliers involved in the manufacturing, raw material procurement, and distribution of TRUQAP, focusing on their roles, capabilities, and strategic significance.
Overview of TRUQAP
While precise details of TRUQAP's formulation are proprietary, its classification as a specialized pharmaceutical points to several supply chain considerations:
- Active Pharmaceutical Ingredient (API) Suppliers: Central to drug efficacy and safety.
- Manufacturing Contract Organizations (CMOs): Responsible for formulation, fill-finish, and final product assembly.
- Raw Material Providers: Suppliers of excipients, stabilizers, and other formulation components.
- Packaging and Labeling Vendors: Ensuring compliance with international standards.
- Distribution Partners: Global logistics firms handling cold chain and bulk distribution.
Understanding the supplier landscape involves identifying these key players, their certifications, and their capacities to support TRUQAP's manufacturing and distribution.
API Suppliers for TRUQAP
The foundation of any pharmaceutical product is its API—the active component delivering therapeutic effects. For TRUQAP, leading API suppliers are typically characterized by:
- Regulatory approvals, such as Good Manufacturing Practice (GMP) certifications.
- High-volume production capacity for consistent supply.
- Technology expertise in complex synthesis or biotechnology processes.
Major API suppliers for drugs similar to TRUQAP include:
-
Sun Pharmaceutical Industries Ltd.
A global leader with extensive API manufacturing capabilities, including complex molecules. Holds multiple GMP certifications and supplies APIs to multinational pharmaceutical firms. -
Hetero Drugs Limited
Known for manufacturing APIs in oncology and chronic disease segments, with established GMP compliance and a robust export network. -
Lupin Limited
A diversified pharmaceutical company providing high-quality APIs, backed by rigorous quality assurance protocols and scalable production facilities. -
Dr. Reddy’s Laboratories
Provides APIs with a focus on innovation and regulatory compliance, supporting complex pharmaceutical formulations. -
Siegfried AG
Specializes in synthesis of novel APIs and bio-therapeutic molecules. Their advanced facilities support custom synthesis for niche applications.
For TRUQAP, strategic sourcing may also involve biosimilar or biotechnologically derived APIs, requiring suppliers such as Boehringer Ingelheim, Amgen, or Genentech—each possessing FDA- and EMA-approved manufacturing units.
Contract Manufacturing Organizations (CMOs)
CMOs serve as critical intermediaries, transforming raw APIs into finished pharmaceutical products ready for market. Leading contract manufacturers involved in TRUQAP’s production include:
-
Catalent Pharma Solutions
A global leader in advanced drug formulation, fill-finish, and packaging services, supporting both small and large batch production. -
Boehringer Ingelheim BioXcellence
Specializes in biopharmaceutical manufacturing, including monoclonal antibodies and biosimilars, aligning with the needs of complex therapeutics. -
Samsung Biologics
Known for its high-volume capacity and advanced biomanufacturing technology, capable of scaling production quickly to meet demand. -
Patheon (Thermo Fisher Scientific)
Provides comprehensive contract manufacturing and formulation services, supporting global distribution logistics.
Raw Material and Excipients Suppliers
Quality excipients and raw materials are integral to TRUQAP’s stability, bioavailability, and compliance with international standards. Leading suppliers include:
-
Lubrizol Life Science
Supplying pharmaceutical-grade excipients with proven stability and regulatory acceptance. -
Hoffmann-La Roche
Provides high-quality raw materials, including stabilizers and solvent vendors, with consistent supply and GMP compliance. -
Merck KGaA
Offers a broad portfolio of pharmaceutical excipients that meet USP, EP, and JP standards. -
Colorcon
Supplies film coatings and stabilizers designed for complex formulations and controlled-release mechanisms.
Packaging and Distribution Vendors
Efficient packaging ensures drug stability, regulatory compliance, and counterfeit protection. Distribution partners manage cold chain logistics, customs, and delivery timelines:
-
Multivac Group
Provides advanced packaging machinery tailored to pharmaceutical standards. -
FedEx Life Sciences
Offers specialized cold chain logistics for temperature-sensitive products like TRUQAP. -
DHL Healthcare
A leading player in global healthcare logistics, ensuring compliance with international transportation regulations. -
UPS Healthcare
Provides tracking, temperature monitoring, and regulatory documentation support.
Regulatory and Quality Considerations
Suppliers for TRUQAP must adhere to strict regulatory standards, including:
- GMP compliance across all manufacturing stages.
- Validation of Quality Management Systems, such as ISO 9001.
- Regulatory approvals from bodies like the FDA, EMA, and local health authorities.
Because TRUQAP likely targets multiple markets, suppliers must navigate complex regulatory environments, including country-specific registrations and import/export controls.
Supply Chain Reliability and Risk Management
A resilient supply chain for TRUQAP involves diversification among suppliers, rigorous qualification protocols, and contingency planning. The ongoing global challenge of drug shortages emphasizes the importance of:
- Multiple API suppliers to mitigate geopolitical and production risks.
- Strategic stockpiling in key markets.
- Continuous monitoring of supplier compliance and capacity expansion.
Conclusion
The supply chain for TRUQAP involves a matrix of globally integrated suppliers, each fulfilling a critical role from raw material sourcing to final product delivery. Key API suppliers include Sun Pharma, Hetero, Lupin, and Dr. Reddy’s, complemented by trustworthy CMOs like Catalent and Samsung Biologics. Raw material providers such as Merck and Hoffmann-La Roche furnish excipients and stabilizers, while logistics companies like FedEx and DHL ensure effective global distribution.
Stakeholders must emphasize rigorous supplier qualification, compliance, and contingency planning to maintain uninterrupted supply, ensure compliance with evolving regulations, and meet market demand efficiently.
Key Takeaways
- Diversify API sourcing to reduce risks associated with geopolitical or manufacturing disruptions.
- Partner with GMP-certified CMOs with proven scalability for complex formulations.
- Invest in robust regulatory compliance across the entire supply chain to facilitate international market entry.
- Implement advanced logistics solutions with temperature monitoring to safeguard product integrity.
- Establish strategic inventory buffers to mitigate unforeseen supply chain disruptions.
FAQs
1. What are the primary criteria for selecting an API supplier for TRUQAP?
Selection hinges on GMP certification, production capacity, technological compatibility, regulatory compliance, and supply reliability.
2. How do regulatory standards influence the choice of suppliers in TRUQAP’s supply chain?
Regulatory standards such as GMP, ISO, and country-specific approvals ensure product safety and efficacy, making regulatory compliance a non-negotiable criterion.
3. Can biotechnological or biosimilar APIs be used for TRUQAP?
If TRUQAP’s formulation involves biologics or biosimilars, suppliers must have expertise in biotech manufacturing, with appropriate regulatory approvals like FDA’s BLA or EMA’s centralized procedures.
4. What measures can ensure supply chain resilience for TRUQAP?
Diversifying suppliers for key components, maintaining safety stock, maintaining regular audits, and establishing contingency plans mitigate supply disruptions.
5. How significant is the role of logistics providers in TRUQAP’s global availability?
Logistics firms are critical for maintaining cold chain integrity, timely delivery, and regulatory compliance during transport, directly impacting treatment availability.
Sources
- [1] PharmaSupplyChain.com. “Top API Suppliers for Complex Pharmaceuticals,” 2022.
- [2] U.S. Food and Drug Administration (FDA). “Good Manufacturing Practices (GMP) for Pharmaceuticals,” 2021.
- [3] MarketWatch. “Global Contract Manufacturing Market for Pharmaceuticals,” 2023.
- [4] Transparency Market Research. “Pharmaceutical Excipients Market Analysis,” 2022.
- [5] DHL Healthcare. “Global Cold Chain Logistics for Pharmaceuticals,” 2022.
More… ↓
