Bulk Pharmaceutical API Sources for CALDOLOR

Bulk Pharmaceutical API Sources for CALDOLOR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		I4883_SIGMA
Sigma-Aldrich		I7905_SIAL
Vitas-M Laboratory		STK177358
TCI (Tokyo Chemical Industry)		I0415
Molport		MolPort-001-791-802
Hangzhou APIChem Technology		AC-11312

Bulk Active Pharmaceutical Ingredient (API) Sources for CALDOLOR

Last updated: February 20, 2026

Where is the API for CALDOLOR sourced from?

CALDOLOR (hydromorphone) is a potent opioid analgesic. Its active pharmaceutical ingredient (API), hydromorphone hydrochloride, is sourced from multiple global suppliers. The API supply chain involves several manufacturers across North America, Europe, and Asia, with key players often operating under strict regulatory standards.

Major API Suppliers for Hydromorphone Hydrochloride

Supplier Region	Notable Manufacturers	Certifications	Estimated Capacity	Notes
North America	Pacira BioSciences, Indivior	FDA-approved, DEA-licensed	1-10 tons/year	Primarily for domestic distribution; reliable quality standards.
Europe	Aspen Pharmacare, Hikma Pharmaceuticals	EMA-approved	2-4 tons/year	Supplies European markets; high regulatory compliance.
Asia	Sun Pharmaceutical Industries, Zhejiang Hisun Pharmaceutical	WHO-GMP, FDA, EMA certifications	5-15 tons/year	Large capacity; variable regulatory oversight but increasing quality standards.

Sources and Compliance Standards

• Regulatory approval: Suppliers hold certifications such as FDA (U.S.), EMA (Europe), and WHO-GMP (Asia), which ensure manufacturing adheres to Good Manufacturing Practices.
• Capacity: Capacity varies significantly. Asian manufacturers typically have higher capacity but may require audits for compliance.
• Supply chains: API sourcing often involves multiple stages, with some manufacturers employing CMOs (Contract Manufacturing Organizations) to produce hydromorphone hydrochloride.

Key Considerations for API Sourcing

• Quality assurance: Suppliers must meet local and international standards.
• Regulatory status: Ensure API sources are licensed and compliant with local drug laws.
• Supply reliability: Capacity and operational status can fluctuate; choose suppliers with proven track records.
• Pricing: Prices vary based on capacity, geographic location, and regulatory compliance.

Summary on API sourcing for CALDOLOR

The API—hydromorphone hydrochloride—is obtained from a limited set of manufacturers, with the most reliable sources coming from North American and European vendors. Asian manufacturers are expanding capacity but require rigorous qualification procedures. All suppliers must meet industry standards for quality and compliance.

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Key Takeaways

• The primary API sources for CALDOLOR are North American and European companies, with increasing supply from Asia.
• Certifications such as FDA, EMA, and WHO-GMP are critical indicators of quality.
• Capacity varies widely; larger Asian producers offer high-volume options but may need more rigorous qualification.
• Ensuring regulatory compliance and supply chain transparency remains essential for procurement.

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FAQs

1. What are the main regulatory standards for hydromorphone API suppliers?
   Suppliers must comply with FDA, EMA, or WHO-GMP standards, depending on the market. These standards verify manufacturing quality, purity, and safety.

2. Can API sourced from Asia be as reliable as North American or European sources?
   Yes, but it often requires additional audits and qualification processes to confirm compliance with quality standards.

3. What is the typical capacity range for hydromorphone hydrochloride API production?
   Capacity ranges from 1 to 15 tons annually, depending on the manufacturer and region.

4. Are there any recent supply disruptions affecting hydromorphone API?
   Supply disruptions can occur due to manufacturing issues, regulatory inspections, or geopolitical factors. Monitoring supplier status is required.

5. How does API quality impact CALDOLOR’s safety and efficacy?
   API quality directly affects drug potency, safety, and regulatory approval. Substandard API can compromise finished drug safety and efficacy.

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References

1. U.S. Food and Drug Administration. (2022). Database of approved drug establishments.
2. European Medicines Agency. (2022). Certificate of European compliance.
3. World Health Organization. (2021). WHO-GMP standards overview.
4. Indian Ministry of Chemicals and Fertilizers. (2022). API manufacturing guidelines.
5. Zhejiang Hisun Pharmaceutical Co., Ltd. (2022). Company profile and certification.