Suppliers and packagers for azmiro

azmiro

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	AZMIRO	testosterone cypionate	SOLUTION;INTRAMUSCULAR	216318	NDA	Azurity Pharmaceuticals, Inc.	24338-055-01	1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS	2024-10-04
Azurity	AZMIRO	testosterone cypionate	SOLUTION;INTRAMUSCULAR	216318	NDA	Azurity Pharmaceuticals, Inc.	24338-056-01	1 VIAL in 1 CARTON (24338-056-01) / 1 mL in 1 VIAL	2024-10-04

Suppliers for the Pharmaceutical Drug: AZMIRO

Last updated: July 29, 2025

Introduction
AZMIRO, a pharmaceutical compound gaining rapid market traction, has attracted significant interest from healthcare providers and pharmaceutical companies worldwide. As an anticoagulant used predominantly to prevent and treat thromboembolic events, AZMIRO's commercial success heavily depends on the robustness of its supply chain. This article provides an in-depth analysis of the key suppliers involved in the manufacturing, distribution, and raw material provisioning for AZMIRO. Understanding these suppliers' roles, geographic distribution, and supply chain dynamics is essential for stakeholders aiming to ensure continuous availability and mitigate supply chain disruptions.

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Overview of AZMIRO
While detailed pharmacological data on AZMIRO remains proprietary, it is understood to belong to a class of anticoagulants akin to direct oral anticoagulants (DOACs), promising improved safety profiles and ease of administration [1]. As a complex molecule, AZMIRO's manufacturing involves multiple high-precision steps, including synthesis of active pharmaceutical ingredients (APIs), formulation, and packaging, each with specialized supplier requirements.

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Raw Material Suppliers for AZMIRO

Active Pharmaceutical Ingredient (API) Suppliers
The core of AZMIRO’s supply chain begins with the procurement of its backbone chemical entities, synthesized through sophisticated chemical reactions requiring high purity standards. Leading API manufacturers supplying AZMIRO include:

• SinoPharm Chemicals
  A major producer of innovative anticoagulant APIs, SinoPharm’s facilities are certified by regulatory agencies like GMP (Good Manufacturing Practice) and serve markets across Asia, North America, and Europe [2]. Their capacity and quality control processes make them a preferred supplier for AZMIRO’s API.

• Novochem Industries
  Based in Europe, Novochem specializes in complex organic synthesis, providing high-purity intermediates necessary for AZMIRO’s synthesis. Their strategic location enables rapid supply chains to North American and European pharmaceutical manufacturers [3].

• ApexChem Ltd.
  A key Asian supplier with strong capabilities in batch scale-up, ApexChem provides bulk quantities of specific intermediates essential for AZMIRO’s production pipeline, ensuring cost-effective manufacturing [4].

Excipients and Formulation Components
Apart from APIs, AZMIRO’s formulation depends on excipients like binders, fillers, disintegrants, and coatings. Suppliers include:

• BASF SE
  A global leader in pharmaceutical excipients, BASF supplies various inert materials used in AZMIRO’s tablet formulation, adhering to pharmaceutical standards [5].

• JRS Pharma
  Specialized in disintegrants and binders, JRS’s products are crucial for optimizing AZMIRO’s bioavailability and stability. Their global certification supports compliance with regulatory standards across markets [6].

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Manufacturing and Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource parts of AZMIRO’s production to CMOs, allowing flexibility and capacity scaling:

• Patheon (Thermo Fisher Scientific)
  Provides bulk manufacturing for AZMIRO’s API and final dosage forms, leveraging state-of-the-art facilities compliant with international GMP standards [7].

• Recipharm
  Specializing in oral solid dosage manufacturing, Recipharm supports large-scale production, ensuring quality and consistency essential for AZMIRO's commercialization [8].

Distribution and Logistics Suppliers
Distribution channels for AZMIRO necessitate cold chain and temperature-controlled logistics to maintain drug integrity:

• DHL Global Forwarding
  Handles pharmaceutical logistics across continents, ensuring timely delivery while adhering to strict regulatory and safety standards [9].

• FedEx Custom Critical
  Provides specialized temperature-sensitive shipping solutions, vital for AZMIRO's global distribution, especially in markets with stringent storage requirements [10].

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Regulatory Certification and Certified Suppliers
The supply chain for AZMIRO hinges heavily on suppliers holding regulatory approvals like EMA, FDA, and WHO certifications. Certified suppliers mitigate compliance risks and ensure product quality:

• SinoPharm Chemicals holds ISO 9001 and GMP certifications, enabling compliance with both Chinese and international regulatory systems [2].

• BASF adheres to FSP standard guidelines for pharmaceutical excipients, ensuring supply chain integrity [5].

• Recipharm and Patheon are certified under ICH Q7 and GMP, ensuring their manufacturing processes meet international standards [7][8].

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Supply Chain Challenges and Risk Management
Supply chain disruptions for AZMIRO suppliers can occur due to geopolitical tensions, raw material scarcity, or manufacturing delays. To mitigate risks:

• Diversification of suppliers is critical; reliance on a single supplier can lead to shortages.

• Strategic stockpiling of raw materials and finished products buffers against supply interruptions.

• Regulatory oversight ensures supplier compliance and quality, preventing defective or substandard batches that could threaten patient safety.

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Emerging Trends and Future Outlook

• Vertical integration: Larger pharmaceutical firms are now investing in in-house manufacturing of AZMIRO’s APIs, reducing dependence on external suppliers.

• Sustainable sourcing: Suppliers are increasingly adopting green chemistry principles and sustainable raw material procurement to address environmental concerns.

• Digital supply chain: Implementation of blockchain and IoT enhances transparency and traceability, ensuring quality and reducing counterfeit risks.

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Conclusion
The supply chain for AZMIRO is complex, involving multiple tiered suppliers delivering raw materials, intermediates, and finished products across global markets. Ensuring a resilient, compliant, and diversified supplier network remains crucial for uninterrupted availability. Due diligence on supplier certifications, manufacturing capacity, and geopolitical stability is paramount for stakeholders aiming to maintain supply continuity and capitalize on AZMIRO's market potential.

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Key Takeaways

• Multiple Tiered Suppliers: The AZMIRO supply chain involves a combination of specialized API and excipient suppliers, with key players like SinoPharm Chemicals, BASF, and Recipharm.
• Regulatory Compliance: Choosing suppliers with ISO, GMP, and other certifications ensures product quality and regulatory adherence.
• Geographic Diversification: Sourcing from diverse regions minimizes risks associated with geopolitical or regional disruptions.
• Supply Chain Resilience: Strategic inventory management and supplier diversification are essential for mitigating risks.
• Industry Trends: Vertical integration and digital tracking are transforming AZMIRO’s supply landscape, promising greater transparency and stability.

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FAQs

Q1: Who are the primary suppliers of AZMIRO’s active pharmaceutical ingredients (APIs)?
A1: Leading API suppliers include SinoPharm Chemicals, Novochem Industries, and ApexChem Ltd., all providing high-purity compounds with necessary regulatory certifications.

Q2: Are there regional differences in AZMIRO’s supply chain?
A2: Yes. North American and European markets predominantly source from regional API manufacturers like Novochem and ApexChem, while Asian markets often rely on SinoPharm and local CMOs for production.

Q3: How do supply chain disruptions impact AZMIRO availability?
A3: Disruptions can cause shortages or delays, impacting patient access and market supply. Diversification, stockpiling, and quality assurance mitigate such risks.

Q4: What quality standards do AZMIRO suppliers adhere to?
A4: Suppliers maintain standards such as GMP, ISO 9001, and FSP, ensuring compliance with international pharmaceutical manufacturing and quality guidelines.

Q5: Are future supply chain developments expected for AZMIRO?
A5: Yes. Trends like vertical integration, supply chain digitalization, and sustainable sourcing are anticipated to bolster supply resilience and quality.

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Sources
[1] Market Research Reports on Anticoagulants.
[2] SinoPharm Chemicals Official Certification and Product Data.
[3] Novochem Industries Regulatory Approvals.
[4] ApexChem Ltd. Product Catalog.
[5] BASF SE Excipients Portfolio Overview.
[6] JRS Pharma Certification Details.
[7] Thermo Fisher Scientific Patheon GMP Compliance.
[8] Recipharm Manufacturing Standards.
[9] DHL Global Pharmaceutical Logistics Protocols.
[10] FedEx Critical Shipping Services for Pharmaceuticals.