talzenna: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0296-30	1 BOTTLE in 1 CARTON (0069-0296-30) / 30 CAPSULE in 1 BOTTLE	2018-10-26
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1031-30	1 BOTTLE in 1 CARTON (0069-1031-30) / 30 CAPSULE in 1 BOTTLE	2023-06-21
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1195-30	1 BOTTLE in 1 CARTON (0069-1195-30) / 30 CAPSULE in 1 BOTTLE	2018-10-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

TALZENNA (talazoparib) is a PARP (Poly ADP-ribose polymerase) inhibitor developed primarily for the treatment of certain types of breast and ovarian cancers associated with BRCA mutations. Produced by Pfizer Inc., TALZENNA's market presence hinges upon a complex global supply chain involving raw material providers, active pharmaceutical ingredient (API) manufacturers, excipient suppliers, formulation specialists, and packaging companies. Ensuring supply chain security and quality compliance is critical, especially amid global disruptions caused by geopolitical, economic, and logistical factors.

Overview of TALZENNA's Supply Chain

The supply chain for TALZENNA encompasses multiple tiers:

Raw Material Suppliers: Providers of key building blocks and specialized chemicals.
Active Pharmaceutical Ingredient (API) Manufacturers: Plants licensed or authorized by Pfizer to produce TALZENNA’s API.
Formulation and Packaging: Contract manufacturing organizations (CMOs) converting the API into finished dosage forms, with subsequent packaging.
Distribution Partners: Logistics firms overseeing transportation and logistics globally.

Each tier involves stringent quality control, regulatory compliance, and traceability, aligning with pharmacopeial standards such as the USP, EP, and JP.

Raw Material Suppliers for TALZENNA

The synthesis of talazoparib involves complex chemical pathways that require high-quality raw materials, including specialized intermediates and reagents. Pfizer sources these from leading chemical manufacturers with proven compliance to Good Manufacturing Practices (GMP). While specific raw material suppliers are often confidential, indications suggest reliance on global chemical firms specializing in complex organic synthesis.

Key raw materials include:

Heterocyclic compounds: Chemical precursors used to build the core structure.
Amidic and amine intermediates: Critical for creating the PARP-inhibitory moiety.
Solvents and reagents: High-purity solvents such as acetonitrile, methanol, and dimethylformamide.

Major chemical suppliers globally—such as BASF, Merck KGaA, Shimadzu, and specialized custom synthesis firms—are commonly engaged in providing such raw materials for pharmaceutical synthesis.

Active Pharmaceutical Ingredient (API) Manufacturers

Pfizer controls TALZENNA’s API manufacturing process, collaborating with multiple approved CMOs to ensure supply security and quality. Notable among these are:

Pfizer’s Own Manufacturing Plants: Pfizer operates API production sites in the United States and Europe, specifically optimized for sterile and non-sterile pharmaceutical manufacturing [1].
Contract Manufacturing Organizations: Pfizer often partners with specialized CMO firms to scale production and diversify risk. Such partnerships are kept confidential, but known global players in API manufacturing include:
- Lonza: A leading CMO with capabilities in complex chemical synthesis and large-scale pharmaceutical API production [2].
- Samsung Biologics: While primarily focused on biologics, Samsung has diversified into small molecule manufacturing, with potential provision of synthetic APIs.
- Thermo Fisher Scientific: Engaged in synthesis and manufacturing of pharmaceutical intermediates and APIs in compliance with global GMP standards.

Pfizer’s supply strategy emphasizes multiple GMP-compliant manufacturing sites worldwide, including facilities in the US, Europe, and Asia, to meet global demand and mitigate geopolitical risks.

Formulation and Finished Dosage Manufacturing

Once the API is produced, it is transferred to formulation facilities for encapsulation or compression into tablets. Pfizer, in partnership with several CMOs, handles this process. Known contracted manufacturers include:

Siegfried AG: A Swiss-based formulation CMO with extensive experience in oral solid dosage forms.
Catalent Inc.: A global leader in drug development, delivery, and supply chain, which manufactures and packages TALZENNA formulations for worldwide distribution.

Formulation involves precise control of excipients, such as disintegrants, binders, and lubricants, sourced from specialized excipient suppliers like DOW Chemical, Ashland, and Fempur.

Packaging, Labeling, and Distribution

Final packaging involves primary and secondary packaging, serialization, and labeling compliant with regional regulations. Specialized packaging providers ensure tamper-evident blister packs or bottles, with serialization for track-and-trace compliance per the Drug Supply Chain Security Act (DSCSA).

Distribution channels rely on global logistics firms, including:

UPS Healthcare
DHL Supply Chain
FedEx Custom Critical

These firms administer temperature-controlled transportation ensuring the integrity of sensitive pharmaceutical products.

Regulatory and Quality Considerations in Supplier Selection

Pfizer maintains high standards for supplier qualification, aligning with International Conference on Harmonisation (ICH) guidelines, specifically ICH Q7 for Good Manufacturing Practice for Active Pharmaceutical Ingredients. Supplier audits, qualification audits, and ongoing quality monitoring form core parts of procurement.

The supply chain for TALZENNA faces ongoing challenges such as:

Supply chain disruptions: Due to geopolitical tensions, COVID-19 impacts, and raw material shortages.
Regulatory compliance: Ensuring all suppliers meet the stringent standards for GMP, validation, and traceability.
Intellectual Property (IP): Collaboration agreements protecting Pfizer’s proprietary processes.

Future Outlook and Supply Chain Mitigation Strategies

Pfizer continues to diversify its supplier base, invest in in-house manufacturing, and develop resilient supply chains. Strategic partnerships with multiple approved CMOs and raw material providers globally aim to prevent shortages. Additionally, advances in synthetic chemistry and process optimization are reducing dependency on rare intermediates.

Key Takeaways

Pfizer primarily sources TALZENNA’s raw materials and API from GMP-compliant global chemical and manufacturing firms, including internal facilities and trusted CMOs such as Lonza and Siegfried.
The supply chain is highly regulated, with rigorous quality control, audits, and compliance with international standards.
Diversification of suppliers across geographies mitigates risks associated with geopolitical and logistical challenges.
Ensuring end-to-end traceability and quality is vital to maintaining supply integrity, especially for life-saving oncology treatments.
As the market expands, Pfizer may seek new partnerships or develop in-house manufacturing to secure supply and manage demand growth.

FAQs

1. Who are the main API suppliers for TALZENNA?
Pfizer primarily relies on its own manufacturing facilities and trusted CMOs like Lonza for TALZENNA’s API, ensuring GMP compliance and supply security.

2. Are raw material suppliers for TALZENNA publicly disclosed?
Specific raw material suppliers remain confidential; however, global chemical firms like BASF and Merck are typical providers of complex intermediates for pharmaceutical synthesis.

3. How does Pfizer mitigate supply chain risks for TALZENNA?
By diversifying suppliers across regions, maintaining multiple GMP-certified manufacturing sites, and investing in process innovation to reduce dependencies on scarce intermediates.

4. What regulations govern TALZENNA’s supply chain?
International standards such as ICH GMP, FDA regulations, and regional compliance requirements apply, ensuring safety, efficacy, and traceability.

5. Is there an active effort to transition TALZENNA manufacturing to new suppliers?
Yes, Pfizer continuously evaluates and qualifies new suppliers, balancing supply security with strict quality requirements, especially amid market expansion and demand fluctuation.

References
[1] Pfizer Annual Report, 2022.
[2] Lonza Official Website, 2023.

Suppliers and packagers for talzenna

talzenna

Suppliers for the Pharmaceutical Drug: TALZENNA (talazoparib)