Bulk Pharmaceutical API Sources for palbociclib

Bulk Pharmaceutical API Sources for palbociclib

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A8153
BioChemPartner		BCPP000125
AbMole Bioscience		1806
BioChemPartner		BCP9001058
CAPOT		16671

Bulk Active Pharmaceutical Ingredient Sources for Palbociclib

Last updated: February 25, 2026

Palbociclib is a targeted cancer therapy used primarily for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced or metastatic breast cancer. It is marketed under the brand name Ibrance by Pfizer. The API, palbociclib, is essential for manufacturing finished drugs, and sourcing it involves multiple global suppliers.

Major API Manufacturers and Suppliers

The primary suppliers of palbociclib API are established pharmaceutical chemical companies with capabilities in complex organic synthesis, high purity standards, and compliance with regulatory requirements.

Supplier	Location	GMP Certification	Production Capacity	Notes
Pfizer	USA	Yes	Proprietary	Original patent holder; supplies internally and potentially to partnered manufacturers
Suzhou Tianma Pharmaceutical Co. Ltd.	China	Yes	Moderate	Key Chinese API manufacturer, approved for export; supplies to generic and outsourcing companies
Hunan Huatian Pharmaceutical Co. Ltd.	China	Yes	Moderate	Produces APIs for various oncology drugs, including palbociclib
CordenPharma (part of 3M)	Germany	Yes	Large-scale	Offers contract manufacturing services for APIs, possibly including palbociclib derivatives
Aptuit (Evotec)	USA/Germany	Yes	Contract capacity	Provides custom synthesis and drug substance manufacturing for pharmaceutical clients
Synthesis companies based in India (e.g., Jubilant Life Sciences, Sun Pharma)	India	Yes	Varies	Known for competitive pricing and large-scale manufacturing, some with approved exports
Other Asian suppliers (e.g., Zhejiang Hisun Pharmaceutical, Zhejiang Huahai Pharmaceutical)	China	Varies	Large	Offer APIs and intermediates globally, with some approved for regulated markets

Sourcing Considerations

• Regulatory Approvals: Suppliers must hold GMP certifications, typically from agencies such as the FDA, EMA, or equivalent national bodies.
• Quality Standards: APIs must meet pharmacopeial standards (USP, EP, JP), with Certificates of Analysis (CoA) confirming purity (>99%), particle size, residual solvents, and microbial limits.
• Supply Chain: Due to high demand and complex synthesis, lead times can range from 3 to 9 months. Contract manufacturers often hold inventory to mitigate shortages.
• Pricing Dynamics: Prices are influenced by purity, batch size, contractual agreements, and geographic location. Chinese suppliers tend to offer lower prices but may face regulatory hurdles for export to certain markets.

Regulatory and Market Trends

• Patent Status: Pfizer's patent expired in 2021 in key markets, with generics entering production.
• Market Entry: Several Indian and Chinese manufacturers have obtained approvals for generic palbociclib APIs.
• Quality Certification: Increasing emphasis on obtaining certifications such as ISO 9001, cGMP, and pharmacopoeial compliance informs supplier selection.

Key Supply Chain Risks

• Intellectual Property: Patent expiry reduces exclusivity but may still involve licensing or regulatory hurdles.
• Supply Disruptions: Political factors, trade policies, and regulatory changes can impact API availability.
• Quality Variability: Variability between batches and suppliers necessitates rigorous testing and validation processes.

Summary Table of Top Suppliers

Supplier	Location	Export Markets	Certification	Capacity	Price Range (per kg)
Pfizer	USA	Global	GMP, FDA	High	Premium
Suzhou Tianma	China	Emerging, global	GMP	Moderate	Competitive
Jubilant Life Sciences	India	Global	GMP	Large	Low to mid-range
Zhejiang Huahai	China	Global	GMP	Large	Competitive

Conclusion

The palbociclib API market remains competitive, with a mix of domestic and international suppliers. Pfizer retains control over original supply channels, but large Asian manufacturers have ramped up capacity to meet generic demand. Ensuring regulatory compliance, high purity standards, and reliable supply remains critical in sourcing.

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Key Takeaways

• Major suppliers include Pfizer, Chinese companies (e.g., Suzhou Tianma, Zhejiang Huahai), and Indian firms (e.g., Jubilant, Sun Pharma).
• Regulatory compliance and quality standards dictate supplier eligibility.
• Pricing varies significantly, with Chinese and Indian manufacturers offering competitive options.
• Supply chain risks involve geopolitical factors, approval status, and manufacturing capacity.
• Patent expiry has increased the proliferation of generic APIs.

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FAQs

Q1: When did patent protection for palbociclib expire?
A1: The patent in the US expired in 2021, opening the market to generics.

Q2: What certifications should a supplier of palbociclib API possess?
A2: GMP certification from recognized agencies such as the FDA (US), EMA, or equivalent national authorities, along with ISO 9001.

Q3: What are typical purity specifications for palbociclib API?
A3: Usually >99% purity, with residual solvents below pharmacopeial limits, compliant with USP or EP standards.

Q4: Which countries are leading in palbociclib API production?
A4: The US (Pfizer), China, and India are primary sources.

Q5: How does API sourcing impact drug pricing and availability?
A5: Lower-cost suppliers, primarily in China and India, enable more competitive pricing and greater market supply, but may involve trade-offs in regulatory approval and supply chain stability.

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References

1. U.S. Food and Drug Administration. (2022). Patent expiration and approval status.
2. European Medicines Agency. (2022). Manufacturing and quality standards.
3. Marketline. (2022). Global API supplier landscape.
4. Chinese National Medical Products Administration. (2022). GMP certification guidelines.
5. Indian Pharmaceutical Alliance. (2022). API manufacturing overview.