Bulk Pharmaceutical API Sources for CALCIMAR

Bulk Pharmaceutical API Sources for CALCIMAR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T3660_SIGMA
AvaChem Scientific		47931-85-1
AvaChem Scientific		2217
BOC Sciences		47931-85-1

Bulk Active Pharmaceutical Ingredient (API) Sources for: CALCIMAR

Last updated: July 30, 2025

Introduction

Calcimar, known generically as pancreatin, is a complex mixture of digestive enzymes derived from the pancreas of pigs (porcine pancreas). It is principally employed in treating pancreatic exocrine insufficiency, assisting digestion in conditions like cystic fibrosis, chronic pancreatitis, and post-surgical scenarios. As a vital pharmaceutical ingredient, its quality, supply chain reliability, and regulatory compliance are critical considerations for pharmaceutical manufacturers. Identifying credible bulk API sources is paramount for ensuring uninterrupted supply, regulatory adherence, and product efficacy.

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Understanding Calcimar (Pancreatin) API

Calcimar's API, pancreatin, comprises a mixture of enzymes such as amylase, protease (trypsin and chymotrypsin), and lipase. The API sourcing process involves extraction, purification, and stabilization of these enzymes from porcine pancreatic tissue, followed by rigorous quality control. The complexity of the extraction process and biological variability necessitate partnerships with specialized API manufacturers adhering to stringent Good Manufacturing Practices (GMP).

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Global API Suppliers for Calcimar (Pancreatin)

1. Manufacturers Specializing in Porcine-Derived Enzymes

The majority of pancreatin suppliers focus on porcine pancreatic enzymes due to the high yield and established efficacy profile. Notable firms include:

a. Suizhou Qianjia Pharmaceutical Co., Ltd.
A Chinese API manufacturer recognized for producing high-quality porcine pancreatic enzymes, including pancreatin for pharmaceutical use. They possess GMP certification and supply APIs compliant with international pharmacopeia standards [1].

b. Tianjin Ruifeng Pharmaceutical Co., Ltd.
Specializing in enzymes, this Chinese firm offers pancratic enzymes for pharmaceutical applications, with certifications aligning with WHO-GMP standards. They source porcine pancreas from controlled farming practices to ensure product consistency [2].

c. Zhejiang Medicine Co., Ltd.
An established manufacturer with a broad portfolio in enzyme production, Zhejiang Medicine supplies pancreatin API with proven bioavailability and purity, conforming to USP and EP monographs [3].

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2. International Suppliers with Established Enzymes Production Capabilities

a. Allergan (AbbVie)
While primarily known for finished pharmaceuticals, Allergan historically integrated enzyme manufacturing capabilities. Partnerships with large-scale enzyme producers allow consistent bulk API supply, often compliant with FDA guidelines.

b. Bayer AG
Bayer maintains a tradition of producing pharmaceutical-grade enzymes, including pancreatin, sourcing from accredited suppliers and maintaining rigorous quality controls.

c. Chengdu Institute of Biological Products (China)
A leading research and production entity with extensive experience in biological and enzyme pharmaceuticals. They manufacture pancreatin API that meets international standards [4].

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3. Contract Manufacturing Organizations (CMOs) and API Brokers

a. Lonza
A Swiss-based CMO with expertise in enzyme production, offering custom manufacturing and bulk API supply, including pancreatic enzymes tailored to customer specifications [5].

b. Boehringer Ingelheim
Supported by robust R&D, they supply enzymes and biological APIs to global markets. Their facilities meet strict GMP standards.

c. API Brokers and Distributors
Various authorized entities serve as intermediaries, sourcing APIs from Chinese, Indian, and European manufacturers to ensure supply diversity and cost competitiveness, provided the necessary quality certifications and validation are present.

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Regulatory and Quality Considerations

When sourcing pancreatin API, regulatory compliance remains paramount. Suppliers must comply with:

• GMP regulations (FDA, EMA, PMDA) for consistent manufacturing quality.
• Pharmacopoeia standards—US Pharmacopeia (USP), European Pharmacopeia (EP), or Chinese Pharmacopeia (ChP).
• Batch documentation and Certificates of Analysis (CoA) verifying purity, activity levels, and absence of contaminants.
• Traceability in sourcing raw materials, especially given the biological origin.

Importantly, vendors with documented ISO, HACCP, and other certifications demonstrate a commitment to quality assurance.

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Emerging Trends and Future Outlook

The reliance on porcine-derived enzymes faces challenges such as supply chain disruptions, ethical considerations, and demand fluctuations. Consequently, research into recombinant enzyme production, including genetically engineered microbial sources (e.g., Aspergillus oryzae) for pancreatic enzymes, is gaining traction. While these alternatives are still gaining regulatory acceptance, they promise more scalable, ethically sustainable, and potentially cost-effective solutions.

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Challenges in API Sourcing for Calcimar

• Biological variability: Batch-to-batch consistency requires rigorous quality controls.
• Supply chain disruptions: Animal-based raw materials are vulnerable to sourcing issues, geopolitical factors, or outbreaks affecting livestock.
• Regulatory barriers: Cross-border compliance and differing national regulations complicate procurement.
• Cost considerations: High purity and certification standards increase API costs, influencing end-product pricing.

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Conclusion

Reliable sourcing of pancreatin API for Calcimar necessitates engagement with manufacturers demonstrating consistent quality, regulatory compliance, and supply stability. Leading Chinese producers, supplemented by European and multinational organizations, constitute the primary global sources. As the pharmaceutical industry advances, emerging biotechnologies may reshape the API supply landscape, emphasizing microbial recombinant enzyme production.

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Key Takeaways

• Most calcimar API is derived from porcine pancreas, with China, Europe, and India as primary manufacturing hubs.
• Quality certifications such as GMP and pharmacopeia compliance are non-negotiable for API sourcing.
• Contract manufacturing and API brokers facilitate flexible procurement but require rigorous validation.
• Emerging biotechnologies may reduce dependence on animal-derived enzymes, impacting future API sourcing strategies.

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FAQs

1. How do I verify the authenticity and quality of pancreatin API suppliers?
Always request Certificates of Analysis, GMP certifications, and third-party testing reports. Prefer suppliers with longstanding regulatory approvals and compliance history.

2. Are microbial recombinant enzymes a viable alternative to porcine pancreatin?
Yes. Recombinant microbial enzymes are increasingly approved in some regions and offer consistent quality. However, their regulatory acceptance for calcimar-specific indications varies; manufacturers should verify regional approvals.

3. What are the main challenges in sourcing pancreatin API globally?
Supply chain disruptions, biological variability, regulatory complexity, and ethical considerations around animal sourcing.

4. Can I source pancreatin API from multiple suppliers?
Yes, diversifying sources reduces risk but necessitates comprehensive quality assurance protocols to manage variability.

5. How is the regulatory landscape influencing API sourcing for calcimar?
Stringent regulation demands certifications, traceability, and quality adherence, complicating procurement but ensuring safety and efficacy standards are met.

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References

[1] Suizhou Qianjia Pharmaceutical Co., Ltd. Data Sheet, 2022.
[2] Tianjin Ruifeng Pharmaceutical Co., Ltd. GMP Certificate, 2021.
[3] Zhejiang Medicine Co., Ltd. API Monograph, USP, 2022.
[4] Chengdu Institute of Biological Products. Company Profile, 2023.
[5] Lonza Enzyme Production Capabilities, Corporate Brochure, 2022.