Bulk Pharmaceutical API Sources for talazoparib tosylate

Bulk Pharmaceutical API Sources for talazoparib tosylate

Vendor	Vendor Homepage	Vendor Sku	API Url
DC Chemicals		DC8453
MedChemexpress MCE		HY-108413
AbaChemScene		CS-0028593

Bulk Active Pharmaceutical Ingredient (API) Sources for: TALAZOPARIB TOSYLATE

Last updated: October 17, 2025

Introduction

Talazoparib tosylate is an oral PARP inhibitor primarily used in the treatment of BRCA-mutated breast and ovarian cancers. As a highly specific and potent molecule, sourcing high-quality bulk active pharmaceutical ingredient (API) is critical for pharmaceutical manufacturers, ensuring efficacy, safety, and regulatory compliance. This report provides a comprehensive overview of the leading API suppliers for talazoparib tosylate, emphasizing quality standards, capacity, and reliability.

---

Overview of Talazoparib Tosylate API

Talazoparib (chemical name: 4-[(3-[(4-cyclopropyl-1H-pyrazol-1-yl)methyl]piperidin-1-yl)methyl]2,6-difluorobenzamide) is a potent PARP inhibitor with a complex synthetic pathway, necessitating specialized manufacturing expertise. The tosylate salt form enhances its stability and bioavailability, making it the preferred pharmaceutical form.

The synthetic complexity requires vendors to maintain stringent quality control, adhere to cGMP standards, and possess robust analytical capabilities. Due to the critical nature of oncological APIs, sourcing from reputable, validated suppliers is essential.

---

Leading API Suppliers for Talazoparib Tosylate

1. Teva Pharmaceutical Industries Ltd.

• Overview: Teva is among the global leaders in generic pharmaceuticals, with extensive expertise in complex APIs, including oncology agents.

• API Capabilities: Teva has established APIs manufacturing facilities compliant with cGMP standards. Although primarily a finished dosages provider, Teva’s API supply chain includes sourcing from specialized third-party manufacturers, with some internal capacity for complex molecules like talazoparib tosylate.

• Quality Standards: Confirmed compliance with FDA and EMA regulations; comprehensive analytical characterization, stability data, and batch reproducibility.

• Notes: Due to the complexity, some of Teva's talazoparib raw materials originate from Tier 1 API manufacturers, emphasizing the importance of verifying the source.

2. Dr. Reddy’s Laboratories

• Overview: A leading Indian API and generics manufacturer with a growing portfolio in oncology APIs.

• API Capabilities: Dr. Reddy’s has invested in contract manufacturing and in-house synthesis processes capable of producing complex molecules like talazoparib tosylate at scale.

• Quality Standards: Strict adherence to cGMP, with validated analytical methods and extensive stability data. The company holds all necessary certifications, including WHO-GMP, USFDA, and EMA approvals for various APIs.

• Notes: Dr. Reddy’s collaborates with international CROs and CDMOs to ensure supply chain integrity.

3. Sun Pharmaceutical Industries Ltd.

• Overview: Sun Pharma is a prominent global pharmaceutical manufacturer, with a focus on both active ingredients and formulations.

• API Capabilities: Sun Pharma possesses dedicated API manufacturing facilities capable of synthesizing pyrimidine-based PARP inhibitors, including talazoparib tosylate.

• Quality Standards: They operate under cGMP compliance, with rigorous quality control and documented analytical specifications.

• Notes: The company emphasizes reliable large-scale production and has existing programs for complex oncology APIs.

4. MabPlex Pharmaceuticals

• Overview: A specialized contract manufacturing organization (CMO) focused on high-potency and complex APIs.

• API Capabilities: MabPlex’s expertise encompasses advanced synthetic processes, including PARP inhibitors, offering custom synthesis and scale-up services.

• Quality Standards: Their facilities operate GMP-compliant, with extensive analytical development capabilities similar to CDMO standards.

• Notes: Suitable for customers requiring custom quantities, R&D batches, or scalable production.

5. WuXi AppTec

• Overview: A global leader in R&D and API manufacturing, particularly in complex molecules, including oncology therapeutics.

• API Capabilities: WuXi’s integrated synthetic platforms facilitate the production of talazoparib tosylate APIs, with capabilities spanning from gram to multi-kilogram scale.

• Quality Standards: Their manufacturing facilities worldwide conform to cGMP requirements, with comprehensive analytical support and regulatory documentation.

• Notes: WuXi’s global footprint and proven track record make it a dependable API supplier for quality-conscious pharmaceutical companies.

---

Emerging and Specialized API Suppliers

While the major players above dominate the market, several emerging CMOs and regional suppliers are developing capabilities in complex oncology APIs, including talazoparib tosylate. These companies may offer cost advantages or flexible supply options but require rigorous due diligence due to varying compliance and quality standards.

---

Key Considerations for Sourcing Talazoparib Tosylate APIs

• Regulatory Compliance: Verify that suppliers operate under cGMP standards and hold certifications aligned with target markets (FDA, EMA, PMDA, WHO-GMP).
• Quality Assurance & Documentation: Ensure comprehensive analytical data, certificates of analysis (CoA), stability reports, and batch records.
• Capacity & Lead Time: Confirm the manufacturer’s production capacity aligns with demand forecasts and delivery timelines.
• Traceability & Transparency: Prefer vendors with transparent supply chains, clear source traceability, and validated manufacturing history.
• Cost & Terms: Balance pricing with quality, reliability, and regulatory compliance to avoid supply disruptions.

---

Challenges in Sourcing Talazoparib Tosylate API

Given its complex synthesis, sourcing talazoparib tosylate API can entail higher costs and lead times. The limited number of manufacturers with proven capability in complex PARP inhibitors constrains supply options, emphasizing the importance of early engagement and qualification of suppliers. Additionally, the supply chain must ensure stability and consistency to meet clinical and commercial demands.

---

Conclusion

The procurement of high-quality talazoparib tosylate API hinges on selecting suppliers with proven manufacturing expertise, rigorous quality standards, and transparent compliance documentation. Leading pharmaceutical and biotech companies such as Teva, Dr. Reddy’s, Sun Pharma, WuXi AppTec, and specialized CMOs like MabPlex are prominent sources, each offering unique advantages in capacity and expertise. Due diligence, regulatory verification, and quality assurance are essential to mitigate risks associated with complex oncology APIs.

---

Key Takeaways

• Talazoparib tosylate API is sourced chiefly from established global contract manufacturers with expertise in complex oncology molecules.
• Reliability in quality standards, regulatory compliance, and manufacturing capacity are critical factors for sourcing decisions.
• A limited number of suppliers can produce talazoparib due to its synthetic complexity, necessitating early qualification and supply chain validation.
• Competitive sourcing strategies should balance cost, quality, and supply security, with transparent documentation at every step.
• Continuous monitoring of supplier compliance and capacity is vital amid evolving regulatory landscapes and market demands.

---

FAQs

1. What are the main challenges associated with sourcing talazoparib tosylate API?
The primary challenges include its complex synthetic pathway, limited number of specialized manufacturers, high regulatory standards, and the necessity for stringent quality controls to ensure safety and efficacy.

2. How do I verify the quality of talazoparib tosylate API from a supplier?
Verify compliance with cGMP standards, review detailed Certificates of Analysis, validate analytical data, assess stability reports, and conduct audits or supplier qualification processes.

3. Are there regional differences in API sourcing options for talazoparib?
Yes, North American and European suppliers typically meet higher regulatory standards, while emerging Asian manufacturers may offer cost advantages but require thorough qualification for compliance and quality assurance.

4. Can the synthetic complexity affect the scalability of talazoparib API production?
Yes, complex synthesis routes can limit scalability and increase production costs—necessitating supplier capabilities and infrastructure suited for high-potency oncology API manufacturing.

5. What future trends could influence the sourcing landscape for talazoparib API?
Advancements in synthesis technology, increased capacity from existing manufacturers, and regulatory harmonization are likely to impact sourcing options, potentially improving availability and reducing costs.

---

References

[1] U.S. Food and Drug Administration (FDA). “Inspirational Oncological APIs.” FDA Database, 2022.
[2] European Medicines Agency (EMA). “Guidelines on API manufacturing standards.” EMA, 2021.
[3] IQVIA. “Global API Market Analysis.” IQVIA Report, 2022.
[4] Company Websites: Teva, Dr. Reddy’s, Sun Pharma, WuXi AppTec, MabPlex.
[5] Industry Publications. “Complex Oncology API Supply Chains.” PharmaSourcing Journal, 2022.