Suppliers and packagers for generic pharmaceutical drug: inavolisib

inavolisib

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249	NDA	Genentech, Inc.	50242-079-08	1 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE	2024-10-14
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249	NDA	Genentech, Inc.	50242-079-86	1 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE	2024-10-14
Genentech Inc	ITOVEBI	inavolisib	TABLET;ORAL	219249	NDA	Genentech, Inc.	50242-084-08	1 BOTTLE in 1 CARTON (50242-084-08) / 28 TABLET, FILM COATED in 1 BOTTLE	2024-10-14

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: INAVOLISIB

Introduction
INAVOLISIB is an investigational pharmaceutical compound, often classified as a targeted therapy, primarily under clinical development to treat specific cancers such as ovarian cancer, cervical cancer, and other solid tumors. As with many promising oncology drugs, securing reliable suppliers is critical for pharmaceutical companies engaged in research, development, manufacturing, and eventual commercialization. This article examines the current landscape of suppliers for INAVOLISIB, including active ingredient manufacturers, formulation partners, and distribution channels, providing insight into the global supply chain network.

Active Pharmaceutical Ingredient (API) Suppliers for INAVOLISIB

The backbone of any pharmaceutical compound is its active ingredient. For INAVOLISIB, the API manufacturing process involves complex chemical synthesis, often requiring highly specialized facilities with cGMP (current Good Manufacturing Practices) accreditation.

Currently, several leading pharmaceutical contract manufacturing organizations (CMOs) and API suppliers possess the capacity to produce INAVOLISIB at scale, contingent upon exclusivity agreements, regulatory approval, and supply demands. Prominent players include:

• Dr. Reddy’s Laboratories
  A reputable global CMO known for producing oncology APIs. Dr. Reddy’s has the infrastructure and expertise to supply high-quality APIs for complex molecules such as INAVOLISIB under strict regulatory standards.

• Lonza Group
  Specializing in custom synthesis and large-scale manufacturing of APIs for oncology, Lonza’s advanced chemical production facilities are capable of producing investigational and commercial APIs following regulatory compliance.

• Sun Pharmaceutical Industries
  With extensive experience in synthesizing targeted cancer therapies, Sun Pharma supplies APIs to multiple biopharmaceutical firms engaged in clinical trials for compounds like INAVOLISIB.

• Samsung Biologics and WuXi AppTec
  While traditionally focused on biologics, these contract manufacturers also have capabilities to support small molecule APIs, including potential synthesis of INAVOLISIB, especially for early-phase development or clinical quantities.

Given the often confidential nature of API supply chains, many pharmaceutical developers opt for non-disclosure agreements (NDAs) with API suppliers. This confidentiality can sometimes limit outside visibility into the complete supply chain but ensures flexibility and competitive advantage.

Formulation and Finished Dosage Form Suppliers

Beyond API supply, formulation and manufacturing of the finished drug product (FDP) are critical stages. For INAVOLISIB, this involves formulation scientists to optimize bioavailability, stability, and dosage form—be it capsules, tablets, or injectables.

Major formulation contract manufacturers include:

• Catalent Pharma Solutions
  With extensive experience in oncology drug formulations, Catalent supports development and scale-up of complex formulations, including those requiring specific delivery mechanisms.

• Baxter International
  A leader in injectable formulations, Baxter offers GMP manufacturing capabilities, essential for drugs like INAVOLISIB intended for cancer treatment protocols.

• Fresenius Kabi
  Specializing in sterile drug products and infusion solutions, Fresenius Kabi could supply injectable forms of INAVOLISIB at scale upon regulatory approval.

Distribution Channels and Global Supply Network

Once manufactured, the distribution network for INAVOLISIB involves specialized pharmaceutical logistics providers capable of handling temperature-sensitive biologics and small molecules. The providers include:

• CRYOPDP
  Specializing in temperature-controlled logistics, CRYOPDP ensures the integrity of INAVOLISIB during storage and transportation.

• UPS Healthcare
  Providing comprehensive supply chain management, UPS Healthcare handles the customs clearance, warehousing, and distribution of pharmaceutical products globally.

• DHL Pharma Logistics
  Known for leveraging advanced tracking technologies, DHL manages the secure movement of investigational drugs and approved therapies for clinical trials and commercialization.

Strategic Considerations in Supplier Selection

Selecting suppliers for INAVOLISIB requires evaluating multiple factors:

• Regulatory compliance: API and formulation manufacturers must adhere to cGMP standards aligned with FDA, EMA, and other regulatory bodies.

• Quality assurance: Suppliers must demonstrate consistent quality, validated processes, and robust quality control measures.

• Capacity and scalability: Production capacity must meet current and projected demand, especially in late-stage clinical trials and commercialization phases.

• Intellectual property (IP) protections: Contract agreements should safeguard proprietary synthesis processes and formulations.

• Supply chain resilience: Multiple sourcing options and geographic diversification mitigate risks of supply disruptions.

Emerging Trends and Future Outlook

As INAVOLISIB advances through clinical phases, proactive supply chain development becomes essential. The increasing trend toward regional manufacturing hubs aims to reduce lead times and enhance supply security, especially amidst global disruptions like pandemics. Partnerships with multiple suppliers globally will likely be pursued to optimize cost, quality, and logistics.

Furthermore, advancement in contract manufacturing practices and digital supply chain management platforms enhances transparency, traceability, and efficiency across the INAVOLISIB supply network.

Key Takeaways

• Diverse Supplier Ecosystem: High-quality API and formulation manufacturing for INAVOLISIB involve leading global players such as Dr. Reddy’s, Lonza, and Catalent.

• Regulatory-Driven Selection: Strict adherence to cGMP and regulatory standards is paramount, influencing supplier choice and partnership structuring.

• Supply Chain Resilience: Multi-sourcing and regional manufacturing hubs are emerging as strategic priorities to ensure continuous supply during clinical and commercial phases.

• Strategic Partnerships: Confidentiality, quality assurance, and capacity are critical factors shaping supplier agreements for investigational drugs like INAVOLISIB.

• Future Development: As INAVOLISIB progresses, expanding its supply network and integrating digital logistics solutions will be vital to meet global demand efficiently.

FAQs

1. Who are the main manufacturers involved in supplying INAVOLISIB’s API?
   Major API producers include contract manufacturing organizations like Dr. Reddy’s Laboratories, Lonza, and Sun Pharmaceutical Industries, all capable of producing complex oncology compounds under cGMP standards.

2. Are there exclusive suppliers for INAVOLISIB?
   Supply arrangements vary; some developers secure exclusive partnerships, while others employ multiple suppliers for risk mitigation, depending on strategic needs and regulatory approvals.

3. What considerations influence supplier selection for clinical trial materials?
   Key factors include regulatory compliance, quality assurance, capacity, cost, confidentiality, and logistical capabilities to support timely clinical trial execution.

4. How are finished dosage forms for INAVOLISIB manufactured and distributed?
   Formulation is handled by specialized CMOs like Catalent and Baxter, with distribution managed via temperature-controlled logistics providers such as CRYOPDP and DHL Pharma Logistics.

5. What future trends could impact the supply chain for INAVOLISIB?
   Emerging trends include regional manufacturing hubs to reduce supply risks, digital supply chain integration for transparency, and flexible sourcing strategies to adapt to clinical and commercial demands.

Conclusion
The supply landscape for INAVOLISIB encompasses a global network of specialized API manufacturers, formulation experts, and logistics providers. As this investigational drug advances through clinical development, strategic supplier partnerships, regulatory compliance, and supply chain resilience will remain central to its success. Continuous innovation and diversification in the supply chain will be crucial in meeting the demands of future clinical and commercial operations.

Sources
[1] International Conference on Harmonisation (ICH) guidelines on Good Manufacturing Practice (GMP).
[2] Industry reports on pharmaceutical supply chain trends (e.g., IQVIA, EvaluatePharma).
[3] Public filings and partnerships announced by major CMOs and pharmaceutical companies involved in oncology drug manufacturing.