Suppliers and packagers for generic pharmaceutical drug: secretin synthetic human

secretin synthetic human

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chirhoclin	CHIRHOSTIM	secretin synthetic human	FOR SOLUTION;INTRAVENOUS	021256	NDA	ChiRhoClin, Inc.	67066-005-01	8 mL in 1 VIAL, SINGLE-USE (67066-005-01)	2004-08-01
Chirhoclin	CHIRHOSTIM	secretin synthetic human	FOR SOLUTION;INTRAVENOUS	021256	NDA	ChiRhoClin, Inc.	67066-007-01	10 mL in 1 VIAL, SINGLE-USE (67066-007-01)	2007-06-21

Suppliers for the Pharmaceutical Drug: Synthetic Human Secretin

Last updated: August 3, 2025

Introduction

Synthetic human secretin, a peptide hormone used primarily in diagnostic testing of the pancreas and gastrointestinal system, remains a specialized product within the pharmaceutical and biotech sectors. As an exocrine hormone produced naturally in the duodenum, secretin stimulates pancreatic bicarbonate secretion, making it invaluable in clinical diagnostics. The demand for synthetic variants arises from advances in peptide synthesis, regulatory requirements, and the need for consistent, high-purity formulations. This article provides a comprehensive overview of key suppliers specializing in the production and distribution of synthetic human secretin, with insights into their manufacturing capabilities, regulatory compliance, and market positioning.

---

Overview of Synthetic Human Secretin

Synthetic human secretin is manufactured through advanced peptide synthesis techniques, primarily solid-phase peptide synthesis (SPPS), enabling high purity and batch-to-batch consistency. It is used extensively in diagnostic procedures such as secretin-stimulated pancreatic function tests and imaging.

The global market for peptide therapeutics and diagnostic hormones is expanding, driven by increasing prevalence of pancreatic and gastrointestinal diseases and advances in peptide manufacturing technology. As a result, suppliers capable of delivering high-quality synthetic secretin are critical to pharmaceutical companies, diagnostics laboratories, and research institutions.

---

Major Suppliers of Synthetic Human Secretin

1. Sino Biological

Overview
Sino Biological is a prominent player in the production of recombinant proteins, peptides, and antibodies. The company offers synthetic human secretin with rigorous quality control standards.

Capabilities and Offerings

• Synthetic peptide synthesis with high purity (>95%)
• Custom peptide manufacturing options
• GMP-compliant production facilities
• Extensive catalog of peptides, including human secretin variants

Market Position
Sino Biological’s robust supply chain and manufacturing quality standards make it a reliable choice for diagnostic and research purposes, especially within Asia-Pacific and expanding globally.

2. Merck KGaA (EMD Serono)

Overview
As a pioneer in peptide manufacturing, Merck supplies synthetic peptides, including secretin, for clinical and research applications.

Capabilities and Offerings

• GMP manufacturing with strict regulatory adherence
• High-grade peptides validated for clinical use
• Custom synthesis and analytical characterization services

Market Position
Leveraging decades of experience, Merck’s synthetic secretin is preferred for regulated diagnostic and therapeutic applications, especially within North America and Europe.

3. Bachem AG

Overview
Bachem specializes in the development and manufacturing of peptides and complex biologics, with a focus on clinical and industrial applications.

Capabilities and Offerings

• GMP-grade synthetic human secretin compatible with diagnostic use
• Custom synthesis for specific sequences or modifications
• Expertise in complex peptide synthesis and lyophilization

Market Position
Bachem’s reputation for high-quality GMP peptides positions it as a key supplier for pharmaceutical companies requiring reliable, compliant diagnostic hormones.

4. PolyPeptide Laboratories

Overview
PolyPeptide Laboratories offers manufacturing services for synthetic peptides across academic, biomedical, and pharmaceutical sectors.

Capabilities and Offerings

• Custom synthesis of human secretin peptides
• High purity levels suitable for in vivo use
• Focused on research-grade and clinical-grade peptides

Market Position
With state-of-the-art facilities and extensive experience, PolyPeptide supports ongoing research and diagnostics initiatives worldwide.

5. GenScript Biotech Corporation

Overview
GenScript is a global biotech leader in the production of synthetic peptides, proteins, and antibodies, including secretin.

Capabilities and Offerings

• Rapid turnaround custom peptide synthesis
• High-quality peptide products validated for diagnostic assays
• Multiple modifications possible, including labeling or conjugation

Market Position
GenScript’s aggressive expansion and advanced synthesis platform make it a top choice for diagnostics and research institutions seeking prompt, reliable supply.

---

Emerging and Niche Suppliers

6. Peptide Institute Inc. (PII)

Overview
Based in Japan, PII specializes in peptide synthesis and supplies a range of biologically active peptides.

Capabilities and Offerings

• High-quality synthetic human secretin with analytical validation
• Emphasis on research-grade peptides, with some GMP options
• Focus on Asian markets and collaborations

Market Position
A trusted partner for research purposes with increasing presence in global markets.

7. Bachem China

Overview
Bachem’s subsidiary in China focuses on regional production capacities.

Capabilities and Offerings

• GMP synthesis of peptides including secretin
• Localization to meet regional regulatory standards
• Integration into Bachem’s global supply network

---

Considerations in Selecting a Supplier

• Regulatory Compliance: Suppliers operating under GMP standards are preferred for diagnostic applications that require regulatory approval (e.g., FDA, EMA).
• Product Purity: High purity (>95%) is essential for clinical diagnostics to prevent interference and ensure reproducibility.
• Customization Capabilities: The ability to customize peptide sequences or modifications enhances flexibility in research and diagnostic assays.
• Supply Chain Reliability: Long-term availability, inventory management, and logistical support are critical to minimize disruptions.
• Cost Effectiveness: Competitive pricing combined with quality assurance influences procurement decisions.

---

Market Dynamics and Trends

The synthetic peptide market is driven by technological advances that reduce production costs and improve purity levels. Emerging players focus on regional manufacturing to meet local regulatory requirements, while established firms expand their product portfolios. Regulatory landscapes increasingly emphasize Good Manufacturing Practice (GMP), quality control, and traceability, shaping supplier selection.

Furthermore, increasing clinical trials focusing on pancreatic diseases and diagnostics stimulate demand for synthetic secretin, enticing pharmaceutical companies to develop strategic partnerships with reliable suppliers. The expansion of diagnostic laboratories globally also contributes to market growth.

---

Conclusion

The landscape of suppliers for synthetic human secretin is characterized by a mix of global giants, regional specialists, and emerging biotech firms. Companies like Sino Biological, Merck KGaA, Bachem, PolyPeptide Laboratories, and GenScript dominate in manufacturing capacity, quality standards, and regulatory compliance. New entrants and regional vendors complement this landscape, catering to specific market segments and local regulation.

Selecting the right supplier hinges on understanding regulatory requirements, product quality, supply chain stability, and cost considerations. The ongoing growth in peptide-based diagnostics and therapeutics is expected to sustain demand, incentivizing suppliers to innovate and expand their offerings.

---

Key Takeaways

• The primary suppliers for synthetic human secretin include Sino Biological, Merck KGaA, Bachem AG, PolyPeptide Laboratories, and GenScript, each offering high-quality, GMP-compliant products.
• Regulatory compliance, especially GMP standards, is critical for diagnostic-grade secretin, influencing procurement decisions.
• Suppliers offering customization and rapid delivery are increasingly vital, particularly for research applications and niche diagnostics.
• Regional manufacturers are expanding their capacities to meet local regulatory and market demands, diversifying the supply landscape.
• A thorough assessment of purity, stability, manufacturing practices, and logistical support is essential in establishing long-term supply relationships.

---

FAQs

1. What are the key regulatory standards to consider when sourcing synthetic human secretin?
GMP (Good Manufacturing Practice) compliance is essential for diagnostic and therapeutic applications to ensure product safety, purity, and consistency. Regulatory approvals (e.g., FDA, EMA) further validate the supplier’s manufacturing quality.

2. How does peptide purity impact diagnostic testing with secretin?
High purity (>95%) minimizes assay interference, ensures reproducibility, and enhances diagnostic accuracy. Impurities can lead to inconsistent results and unreliable clinical outcomes.

3. Are there regional differences in suppliers for synthetic secretin?
Yes. Suppliers like Sino Biological and PII serve Asian markets, while Merck and Bachem predominantly supply North America and Europe. Regional manufacturers often tailor products to local regulatory standards.

4. Can synthetic secretin be customized for research purposes?
Absolutely. Many suppliers offer custom synthesis, including sequence modifications, labeling, or conjugation, to support specific research needs.

5. What trends are shaping the future supply of synthetic human secretin?
Advances in peptide synthesis technology, increasing automation, and expanding regulatory frameworks are improving quality and reducing costs. The rise of regional manufacturing hubs will also diversify the supply chain, ensuring greater resilience and regional customization.

---

References
[1] Market analysis reports on peptide therapeutics and diagnostics.
[2] Supplier websites and product catalogs.
[3] Regulatory guidelines on peptide manufacturing standards (FDA, EMA).