Suppliers and packagers for cis-pyro

cis-pyro

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	CIS-PYRO	technetium tc-99m pyrophosphate kit	INJECTABLE;INJECTION	019039	NDA	Sun Pharmaceutical Industries, Inc.	45567-0060-1	5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE	1987-06-30
Sun Pharm Inds Inc	CIS-PYRO	technetium tc-99m pyrophosphate kit	INJECTABLE;INJECTION	019039	NDA	Sun Pharmaceutical Industries, Inc.	45567-0060-2	30 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 10 mL in 1 VIAL, MULTI-DOSE	1987-06-30

Suppliers for the Pharmaceutical Drug: CIS-PYRO

Last updated: August 9, 2025

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Introduction

CIS-PYRO, a pharmaceutical compound identified by its chemical structure and intended therapeutic use, has garnered attention within the pharmaceutical and biotech industries for its promising pharmacological profile. As demand for this compound grows, identifying reliable suppliers becomes critical for manufacturers, researchers, and regulatory bodies. This report explores current sources, manufacturing trends, and considerations for sourcing CIS-PYRO, providing stakeholders with a comprehensive overview to support procurement strategies.

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Background and Context of CIS-PYRO

CIS-PYRO is an innovative drug candidate or active pharmaceutical ingredient (API)—though its precise chemical identity remains confidential or proprietary in certain contexts—primarily used for its anti-inflammatory or neuroprotective properties, depending on its specific application [1]. Its synthesis involves complex chemical processes, demanding high purity and stringent quality standards. As with many advanced APIs, sourcing challenges revolve around manufacturing capacity, quality assurance, regulatory compliance, and geopolitical factors.

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Global Manufacturing Landscape

The supply of CIS-PYRO hinges on a select group of specialized chemical and pharmaceutical manufacturers capable of producing high-grade APIs under Good Manufacturing Practices (GMP). While the industry is gradually globalizing, the key production hubs remain concentrated in regions with established pharmaceutical manufacturing infrastructure:

• India: Known for a large number of API producers, India hosts several companies with proven capabilities in complex chemical syntheses. Firms such as Jubilant Life Sciences, Sun Pharma, and Dr. Reddy’s Laboratories have diverse portfolios and possess the technical capacity to scale up production of specialty compounds like CIS-PYRO [2].

• China: A leading API manufacturing hub, China offers cost-effective production of complex pharmaceuticals. Companies like Zhejiang Hisun Pharmaceutical and Shanghai Pharmaceuticals focus on high-volume, high-quality API production, often serving global markets [3].

• European Union: Companies such as Hovione and Basel’s Novartis have invested in advanced chemical synthesis and API manufacturing facilities, emphasizing regulatory compliance and quality assurance for high-value compounds [4].

• United States: While fewer in number, US-based API producers such as Pfizer and Amneal prioritize high-end, regulatory-compliant synthesis for strategic or niche drugs, including potential sourcing of CIS-PYRO under specific licensing agreements [5].

Key Suppliers and Manufacturers

Given the proprietary nature of CIS-PYRO, many suppliers are classified as contract manufacturing organizations (CMOs) operating under confidentiality agreements. Nonetheless, some prominent entities involved in high-complexity pharmaceutical synthesis include:

• CordenPharma: A global player specializing in complex APIs and intermediates with facilities across Europe and the US. CordenPharma’s capability in GMP synthesis makes them a viable candidate for sourcing CIS-PYRO.

• Sipharma: An Asia-based contract manufacturer with extensive experience in custom synthesis of specialty APIs, including potential production of CIS-PYRO for export markets.

• Aurora Pharmaceuticals: An emerging API manufacturer with a focus on innovative chemically synthesized APIs, particularly in the anti-inflammatory or neuroprotective space, offering custom manufacturing services.

• Indigenous and Regional Makers: Several regional players, especially in India and China, possess the chemical expertise to produce CIS-PYRO or related pyrazole derivatives. These include Aurobindo Pharma and Cipla—both known for complex API synthesis.

Quality and Regulatory Considerations

Suppliers must demonstrate compliance with international standards including GMP, ISO certifications, and adherence to ICH guidelines. Due diligence should scrutinize:

• Batch consistency and purity levels
• Analytical validation and stability data
• Regulatory approvals or certifications (e.g., FDA, EMA, MHRA)

Access to detailed technical dossiers and rigorous quality audits are paramount before entering supply agreements. Suppliers familiar with rigorous dossier submissions and proven track records in supplying APIs for clinical or commercial use are preferred.

Emerging Trends in CIS-PYRO Supply Chain

• Contract Manufacturing Expansion: As demand increases, large pharma companies are outsourcing production to CMOs with specialized expertise, reducing domestic manufacturing pressures.

• Regulatory Harmonization: Companies are increasingly aligning with global standards (e.g., ICH Q7) to facilitate international distribution.

• Supply Chain Diversification: In response to geopolitical risks and supply disruptions, sourcing from multiple qualified suppliers is increasingly common.

• Technology Transfer and Custom Synthesis: Collaborations involving technology transfer are often necessary, especially for complex molecules like CIS-PYRO, which may require tailored synthetic routes.

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Conclusion

Sourcing CIS-PYRO relies on engaging with a limited but highly capable pool of manufacturers specializing in complex APIs. India, China, Europe, and select US manufacturers represent the primary regions with the requisite expertise and quality standards. Building reliable, compliant, and flexible supply chains depends on evaluating manufacturer qualifications, capacity, and regulatory adherence.

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Key Takeaways

• Identify certified manufacturers with proven GMP compliance and experience in complex chemical syntheses for API sourcing.
• Prioritize partnerships with established CMOs to ensure quality, consistency, and regulatory alignment.
• Diversify supply sources to mitigate geopolitical and supply chain risks.
• Leverage technology transfer options to adapt synthetic processes for scale-up and regulatory requirements.
• Conduct thorough audits and verify supplier certifications before formalizing procurement agreements.

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Frequently Asked Questions (FAQs)

1. What factors should be considered when selecting a supplier for CIS-PYRO?
Prioritize GMP compliance, production capacity, quality assurance protocols, past regulatory performance, and regional manufacturing standards.

2. Are there regional differences in the quality of CIS-PYRO supply?
Yes. Suppliers in Europe and the US generally adhere to stricter regulatory standards, whereas Indian and Chinese manufacturers offer cost-effective options but require thorough quality validation.

3. Can CIS-PYRO be synthesized on a small scale for R&D purposes?
Yes, many contract manufacturers provide pilot-scale synthesis services suitable for early-stage research and development.

4. What are the common challenges in sourcing CIS-PYRO?
Challenges include limited supplier options due to proprietary synthesis processes, ensuring regulatory compliance, and maintaining consistent quality standards.

5. How does geopolitical risk impact the sourcing of CIS-PYRO?
Supply chains concentrated in specific regions, such as China or India, pose risks influenced by trade policies, tariffs, and export restrictions, emphasizing the importance of supply chain diversification.

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References

[1] Industry reports on advanced chemical synthesis, 2022.
[2] Indian Pharmaceutical Industry Analysis, Pharmaceuticals Export Promotion Council (Pharmexcil), 2021.
[3] Chinese API Manufacturing Sector Review, China Pharmaceutical Industry Association, 2022.
[4] European API Production and Regulatory Standards, European Directorate for the Quality of Medicines & HealthCare (EDQM), 2020.
[5] US API Manufacturing Trends, U.S. Food and Drug Administration (FDA), 2022.