Suppliers and packagers for ANGIOTENSIN LL ACETATE

ANGIOTENSIN LL ACETATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Gland	ANGIOTENSIN LL ACETATE	angiotensin ii acetate	SOLUTION;INTRAVENOUS	216966	ANDA	Gland Pharma Limited	68083-553-01	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-553-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2025-06-03

Suppliers for the Pharmaceutical Drug: ANGIIOTENSIN LL ACETATE

Last updated: August 4, 2025

Introduction

Angiotensin II Acetate, a derivative in the renin-angiotensin system (RAS), functions primarily as a potent vasoconstrictor and plays a crucial role in regulating blood pressure and electrolyte balance. Its pharmaceutical applications are mainly tied to hypertension management, though the compound's synthesis and supply are complex due to its biochemical intricacies and regulatory standards. Securing reliable suppliers is vital for pharmaceutical companies, healthcare providers, and research entities requiring high-quality Angiotensin II Acetate for manufacturing, clinical trials, or research.

Chemical Profile and Supply Chain Context

Angiotensin II Acetate is a synthetic peptide that mimics the endogenous angiotensin II hormone. Its manufacturing involves sophisticated peptide synthesis, requiring precise control over purity and stability. Consequently, suppliers must adhere to strict Good Manufacturing Practices (GMP), ensuring batch consistency and regulatory compliance (FDA, EMA standards).

The pharmaceutical market for Angiotensin II-based therapeutics is constrained by stringent quality standards, limited active pharmaceutical ingredient (API) producers, and geopolitical factors affecting supply chains. As a result, the sourcing landscape comprises a mix of large-scale chemical manufacturers, peptide synthesis specialists, and biotech firms capable of producing clinical-grade and commercial-grade APIs.

Major Suppliers and Manufacturers

1. Novartis AG

Novartis, through its cardiovascular division, has historically been involved in the development of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). Although not directly manufacturing Angiotensin II Acetate as an API, Novartis's extensive peptide synthesis and contract manufacturing units have the capacity to produce specialized peptides like Angiotensin II.

• Capabilities: Custom peptide synthesis, GMP manufacturing, and regulatory compliance.
• Relevance: A potential supplier for research-grade and clinical-grade Angiotensin II Acetate.

2. CSL Limited

CSL operates a division specializing in peptide API manufacturing, including drugs that target the RAS pathway.

• Capabilities: Produces peptide therapeutics with high purity and stability.
• Regulatory Compliance: Meets global GMP standards, suitable for pharmaceutical production.

3. Peptide Suppliers and Contract Manufacturing Organizations (CMOs)

Multiple specialized peptide synthesis companies globally focus exclusively on peptide APIs, including Angiotensin II.

• Polypeptide Group (UK): Offers GMP-grade peptide peptides, including Angiotensin II, primarily for research and clinical trials.
• AI Proteins (Japan): Provides custom peptide synthesis and APIs adhering to strict quality controls.
• Bachem AG (Switzerland): Renowned for their peptide synthesis expertise, Bachem supplies various peptide APIs, possibly including Angiotensin II derivatives.

4. Contract Manufacturing Organizations (CMOs)

• Samsung Biologics and Lonza Group: Major players in biopharmaceutical manufacturing that can accommodate peptide API production for specialized compounds, including Angiotensin II.

Regional Suppliers and Emerging Players

Asia-Pacific Region

• Jiangsu Hengrui Medicine Co., Ltd. (China): Known for cardiovascular therapeutics, with capacity for peptide synthesis.
• Fuji Pharm Co., Ltd. (Japan): Engaged in peptide API manufacturing and research collaborations involving Angiotensin peptides.

Europe

• GenScript Biotech Corporation (Belgium): Offers custom peptide synthesis including Angiotensin II, with GMP-grade options for clinical use.

North America

• CPC Scientific (USA): Provides custom peptide synthesis and GMP manufacturing, capable of producing Angiotensin II for research and clinical applications.

Supply Challenges and Considerations

• Regulatory Barriers: Suppliers must comply with evolving GMP standards, particularly for peptides used in clinical settings.
• Manufacturing Complexity: Peptide synthesis involves multiple purification steps, increasing costs and production timelines.
• Market Demand: Limited commercialization of Angiotensin II Acetate-specific drugs constrains mass production capacity, often resulting in reliance on niche or custom synthesis companies.
• Supply Chain Disruptions: Global geopolitical issues, such as trade restrictions and pandemic-related disruptions, impact the availability of raw materials and manufacturing capacity.

Evaluating Suppliers: Key Criteria

• Regulatory Compliance: GMP certification and quality assurance processes.
• Production Scale: Capability to meet volume requirements, especially for large clinical trials or commercial needs.
• Quality Assurance: Batch consistency, purity levels (>98%), and stability data.
• Pricing and Lead Time: Cost-effectiveness balanced with timely delivery.
• Traceability and Documentation: Comprehensive Certificates of Analysis (CoA) and cGMP adherence.

Emerging Trends and Future Outlook

The growing focus on peptide therapeutics and personalized medicine is likely to expand the supplier base for Angiotensin II Acetate. Advances in peptide synthesis technologies, such as solid-phase synthesis automation and improved purification methods, will further enable smaller biotech firms to enter the supply chain. Additionally, contract manufacturing arrangements may promote diversification, secu rentyping suppliers across regions to mitigate risks.

Furthermore, increasing regulatory scrutiny will favor suppliers with proven GMP standards, transparency, and proven track records, emphasizing the importance of rigorous qualification processes for procurement.

Key Takeaways

• The supply chain for Angiotensin II Acetate involves specialized peptide manufacturers with GMP capabilities, including global players like Bachem and Genscript.
• Limited commercial-scale production necessitates reliance on niche peptide synthesis firms and CMOs, with regional suppliers emerging to meet specific market needs.
• Regulatory compliance, production quality, and supply stability are paramount considerations when selecting suppliers.
• Innovations in peptide synthesis and manufacturing automation are expected to broaden supplier options and decrease costs.
• Geopolitical factors, global health events, and evolving regulations influence supply availability and should inform procurement strategies.

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FAQs

Q1: What are the primary challenges in sourcing Angiotensin II Acetate?
A: The main challenges include complex peptide synthesis processes, strict regulatory standards, limited commercial-scale production, and potential supply chain disruptions due to geopolitical or health crises.

Q2: Which companies are most reputable for GMP-grade Angiotensin II production?
A: Leading reputable companies include Bachem AG, GenScript, CPC Scientific, and Polypeptide Group, all recognized for compliance with GMP standards and high-quality peptide synthesis.

Q3: Can Angiotensin II Acetate be custom-synthesized for research purposes?
A: Yes, several peptide synthesis firms offer custom synthesis of Angiotensin II, often with options for research, clinical, or even pre-commercial quantities, adhering to required regulatory standards.

Q4: How does regional demand influence supplier selection?
A: Regional demand shapes supplier options, with Asia-Pacific emerging as a hub for peptide manufacturing, offering competitive pricing and capacity, while Europe and North America focus on regulatory compliance and high-quality standards.

Q5: What future developments could impact the supply landscape of Angiotensin II Acetate?
A: Advances in peptide synthesis technology, increasing demand for peptide therapeutics, and regulatory harmonization are poised to expand supplier pools and enhance supply stability.

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Sources:
[1] U.S. FDA, Good Manufacturing Practice (GMP) Guidelines
[2] European Medicines Agency (EMA), Quality Standards for Peptides
[3] Market research reports from GlobalData and IQVIA on peptide therapeutics manufacturing
[4] Company websites: Bachem, Genscript, CPC Scientific, Polypeptide Group
[5] Industry publications on peptide synthesis advancements