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

Inavolisib Drug Supply Chain Analysis

Last updated: February 19, 2026

This report details the known and potential suppliers for inavolisib, a PI3K inhibitor developed by Genentech (a member of the Roche Group). The analysis focuses on active pharmaceutical ingredient (API) synthesis and drug product manufacturing, identifying key players and potential supply chain vulnerabilities.

Who Manufactures Inavolisib API?

Genentech, as the originator company, is presumed to conduct significant in-house API manufacturing for inavolisib. However, reliance on Contract Development and Manufacturing Organizations (CDMOs) is common for commercial-scale production and supply chain diversification. Specific CDMOs involved in inavolisib API synthesis are not publicly disclosed by Genentech.

Key Considerations for API Suppliers:

• Synthesis Complexity: Inavolisib's chemical structure suggests a multi-step synthesis process requiring specialized expertise and controlled manufacturing environments. The synthesis pathway involves complex heterocyclic chemistry and chiral control.
• Regulatory Compliance: API manufacturers must adhere to strict Good Manufacturing Practices (GMP) as mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• Capacity and Scalability: Suppliers must demonstrate the capacity to produce API at commercial volumes, with the ability to scale up production to meet market demand.
• Quality Control: Robust analytical methods and quality control systems are essential to ensure the purity, potency, and stability of the API.

Potential CDMOs for Inavolisib API (General Capabilities):

While not confirmed for inavolisib specifically, companies with demonstrated expertise in complex small molecule synthesis and oncology drug manufacturing include:

• Lonza
• Catalent
• WuXi AppTec
• Thermo Fisher Scientific (Patheon)
• Porton Pharma Solutions

Timeline of Inavolisib Development and Manufacturing:

• Pre-clinical and Early Clinical Phases: Genentech likely managed initial API production internally or through early-stage CDMO partners.
• Late-Stage Clinical Trials and Commercialization: As development progressed, formal CDMO partnerships for scaled API manufacturing would be established. Commercial manufacturing contracts are typically secured well in advance of market approval.

Which Companies Formulate and Fill Inavolisib Drug Product?

The formulation and fill-finish of inavolisib into its final dosage form (likely an oral solid dosage, such as a capsule or tablet) are also critical stages in the supply chain. Genentech is expected to utilize a combination of internal manufacturing capabilities and external CDMOs for this process.

Key Requirements for Drug Product Manufacturers:

• Dosage Form Expertise: Experience in manufacturing specific dosage forms (e.g., capsules, tablets) including granulation, blending, compression, and coating.
• Packaging Capabilities: Aseptic filling and packaging capabilities if the drug product requires sterile manufacturing, or robust packaging lines for solid oral dosage forms.
• Analytical Testing: Comprehensive testing of the finished drug product for identity, strength, quality, and purity.
• Supply Chain Integration: Ability to integrate with API suppliers and distribution networks.

Potential CDMOs for Inavolisib Drug Product (General Capabilities):

• Catalent
• Thermo Fisher Scientific (Patheon)
• Sharp Manufacturing
• Avara Pharmaceutical Services
• AbbVie (API Development Services)

Geographic Considerations:

Manufacturing sites for both API and drug product are strategically located to ensure supply chain resilience and meet regulatory requirements. Companies often have multiple manufacturing sites to mitigate risks associated with geopolitical instability, natural disasters, or regulatory changes.

What are the Key Raw Materials and Intermediates?

The synthesis of inavolisib involves a series of chemical reactions utilizing various raw materials and intermediates. Identifying these specific components is challenging due to proprietary information surrounding Genentech's manufacturing processes. However, based on its chemical structure (a complex heterocyclic compound), the synthesis would likely involve:

• Specialty Chemicals: Sourcing of advanced chemical building blocks with specific functional groups and stereochemistry.
• Solvents: A range of organic solvents for reactions, purifications, and extractions.
• Reagents: Catalysts, acids, bases, and other chemical reagents required for specific transformations.
• Chiral Auxiliaries/Catalysts: If stereoselective synthesis is employed, specialized chiral compounds will be necessary.

Sourcing Challenges and Strategies:

• Supplier Qualification: Rigorous qualification of raw material suppliers to ensure consistent quality and reliability.
• Dual Sourcing: Establishing relationships with multiple suppliers for critical raw materials to mitigate supply disruptions.
• Geographic Diversification: Sourcing raw materials from different regions to reduce dependency on single markets.
• Intellectual Property (IP) Protection: Ensuring that suppliers adhere to confidentiality agreements regarding the specific intermediates and raw materials used in inavolisib synthesis.

Example of Potential Intermediate Types (Hypothetical):

Based on common synthetic strategies for PI3K inhibitors, one might expect intermediates such as:

• Substituted pyrimidines or purines
• Aryl or heteroaryl halides
• Amine building blocks
• Alcohols or ethers

The specific suppliers for these intermediates are not publicly disclosed and are likely managed through confidential agreements with specialized fine chemical manufacturers.

Who are the Key Clinical Trial Suppliers?

During the clinical trial phases of inavolisib, specialized suppliers are engaged for the manufacturing and distribution of investigational medicinal products (IMPs). This often involves smaller batch sizes and specialized logistics.

Roles of Clinical Trial Suppliers:

• Clinical Trial Material (CTM) Manufacturing: Production of inavolisib API and drug product specifically for clinical studies. This can be performed by the originator or specialized CDMOs with cGMP capabilities for clinical batches.
• Packaging and Labeling: Custom packaging and labeling for different trial sites and patient populations.
• Global Distribution and Logistics: Management of complex global supply chains to deliver IMPs to clinical trial sites worldwide, often under cold chain or specific storage conditions.
• Comparator Drug Sourcing: If inavolisib is being studied against an existing therapy, suppliers will be needed to procure and manage comparator drugs.

Companies Specializing in Clinical Trial Supply:

• Cenduit (now part of Thermo Fisher Scientific)
• Almac
• World Courier (a Fresenius Kabi company)
• PCI Pharma Services

The specific suppliers for inavolisib's clinical trials would have been selected by Genentech based on their track record, global reach, and expertise in handling oncology investigational drugs.

What are the Regulatory Aspects of Inavolisib Supply?

The supply chain for inavolisib is subject to stringent regulatory oversight by health authorities worldwide.

Key Regulatory Requirements:

• Good Manufacturing Practices (GMP): All manufacturing sites for API and drug product must comply with current GMP standards. Regular inspections by regulatory agencies ensure adherence.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies, providing detailed information about the manufacturing process, quality control, and facilities. This allows drug product manufacturers to reference the API information without disclosure.
• Chemistry, Manufacturing, and Controls (CMC): Comprehensive CMC data detailing the manufacturing process, specifications, analytical methods, and stability of the drug substance and drug product must be submitted to regulatory authorities for drug approval.
• Supply Chain Audits: Originator companies like Genentech conduct regular audits of their suppliers to ensure ongoing compliance and quality.
• Import/Export Regulations: Adherence to international regulations governing the import and export of pharmaceutical ingredients and finished products.

Specific Regulatory Bodies:

• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• Pharmaceuticals and Medical Devices Agency (PMDA) in Japan
• Therapeutic Goods Administration (TGA) in Australia

The successful approval and commercialization of inavolisib hinge on the robust and compliant manufacturing and supply chain operations. Any significant deviations or failures in these areas can lead to regulatory actions, production delays, and market withdrawal.

Key Takeaways

• Genentech is the primary developer of inavolisib, indicating significant internal manufacturing control, particularly during early development.
• Commercial-scale production of inavolisib API and drug product is likely managed by a combination of Genentech's internal facilities and a network of qualified Contract Development and Manufacturing Organizations (CDMOs).
• Specific CDMO partners for inavolisib are not publicly disclosed, but leading players in complex small molecule synthesis and oncology drug manufacturing are probable candidates.
• The synthesis of inavolisib requires specialized expertise in heterocyclic chemistry and chiral control, necessitating suppliers with advanced chemical capabilities.
• Raw material and intermediate sourcing involves a complex network of fine chemical suppliers, with dual sourcing and geographic diversification being critical risk mitigation strategies.
• Clinical trial material manufacturing and global distribution are handled by specialized CDMOs and logistics providers.
• The entire inavolisib supply chain operates under strict GMP regulations, requiring extensive documentation (e.g., DMFs) and regular audits by regulatory authorities such as the FDA and EMA.

Frequently Asked Questions

What is the primary manufacturing location for inavolisib API?

The primary manufacturing location for inavolisib API is not publicly disclosed. Genentech, as the originator, may utilize internal facilities or contract with CDMOs located globally.

Which companies are certified to manufacture inavolisib drug product?

Specific certifications for inavolisib drug product manufacturing are not publicly available. Genentech would select CDMOs that meet stringent regulatory standards, including cGMP compliance.

Are there any known single-source suppliers for critical inavolisib intermediates?

Information on single-source suppliers for inavolisib intermediates is proprietary. Pharmaceutical companies typically aim for dual sourcing for critical components to ensure supply chain security.

What are the typical lead times for sourcing specialized intermediates for a drug like inavolisib?

Lead times for specialized intermediates can range from several months to over a year, depending on the complexity of synthesis, raw material availability, and supplier capacity.

How does Genentech ensure the quality of inavolisib API from its suppliers?

Genentech employs rigorous supplier qualification processes, conducts regular audits of manufacturing sites, and requires comprehensive quality control testing and documentation for all supplied materials to ensure the quality of inavolisib API.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Good Manufacturing Practice for Active Pharmaceutical Ingredients. Retrieved from [FDA website - specific guidance document URL would be included if available] [2] European Medicines Agency. (n.d.). Good manufacturing practice (GMP)«. Retrieved from [EMA website - specific guidance document URL would be included if available] [3] Genentech. (n.d.). Company Information. Retrieved from [Genentech corporate website URL] [4] Roche. (n.d.). Company Information*. Retrieved from [Roche corporate website URL]