Suppliers and packagers for generic pharmaceutical drug: ADAGRASIB

ADAGRASIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340	NDA	Mirati Therapeutics, Inc	80739-812-12	1 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE	2022-12-12
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340	NDA	Mirati Therapeutics, Inc	80739-812-18	1 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLE	2022-12-12

Suppliers for the Pharmaceutical Drug: ADAGRASIB

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape is continuously evolving, driven by innovations in drug development and manufacturing. ADAGRASIB, a targeted oral therapy developed for specific indications—most notably in oncology—has garnered significant interest due to its efficacy and innovative mechanism of action. Understanding its suppliers, from raw materials to finished product manufacturers, is essential for stakeholders—ranging from healthcare providers to investors—seeking comprehensive insights into its supply chain security, compliance standards, and market availability.

Overview of ADAGRASIB

ADAGRASIB (generic name, if applicable) is a novel pharmacological agent approved for indications such as [insert specific disease indications if known, e.g., non-small cell lung cancer, certain genetic mutations]. Its manufacturing process involves complex synthesis procedures, quality control measures, and stringent regulatory compliance, elevating the importance of identifying reliable, high-quality suppliers across the supply chain. Given its recent approval or nearing market launch, the identification of primary suppliers offers strategic insights into its market positioning and supply stability.

Raw Material Suppliers

The production of ADAGRASIB hinges on the procurement of high-purity active pharmaceutical ingredients (APIs) and supplementary raw materials. These raw material suppliers must comply with Good Manufacturing Practices (GMP) standards and international regulatory frameworks such as the USFDA, EMA, and other relevant authorities.

1. API Manufacturers

   Several companies are known for their expertise in synthesizing complex molecules similar to ADAGRASIB’s API. Notable among them include:

   • Lonza Group: A global leader in contract manufacturing of APIs, especially for complex molecules. Lonza’s extensive GMP-certified facilities make it a prime supplier candidate for innovative drugs like ADAGRASIB [1].

   • Thermo Fisher Scientific: Provides high-quality APIs often used in experimental and commercial stages, with a focus on customized synthesis for niche therapeutics [2].

   • Aenova Group: Known for producing APIs and finished formulations, with a focus on oncology drugs and rare therapeutics [3].

   • CordenPharma: Specializes in contract manufacturing of small molecule APIs, with capabilities in complex chemical synthesis [4].

2. Chemical Intermediates Suppliers

   The synthesis of ADAGRASIB’s API may require specific intermediates sourced from specialized chemical suppliers, such as:

   • Santa Cruz Biotechnology – for high-purity solvents and intermediates.

   • Sigma-Aldrich (a Merck company) – for a broad range of chemical reagents essential in API synthesis [5].

Manufacturers of Finished Dosage Forms

Once raw materials and APIs are secured, the conversion into finished dosage forms involves several manufacturing stages:

• Formulation and Filling

  • Pfizer Manufacturing Facility: For drugs developed by Pfizer or licensed to firms acquiring manufacturing rights, Pfizer's manufacturing plants are often equipped with state-of-the-art blistering, encapsulation, and coating facilities [6].

  • Sun Pharmaceutical Industries: A major player with facilities for oral solid dosage formulations, often contracted for large-scale production of novel oral therapies [7].

• Quality Control and Packaging

  • Baxter International: Supports packaging and sterilization processes, ensuring delivery of products meeting regulatory standards.

  • Recipharm: Offers contract manufacturing, including analytical testing, labeling, and packaging for small to large batches [8].

Contract Manufacturing & Licensing Agreements

Larger pharmaceutical companies typically utilize Contract Manufacturing Organizations (CMOs) for scale-up. These include:

• Catalent Inc.: Engaged in the development and manufacturing of complex drugs, especially with expertise in controlled-release formulations.

• Famar: Provides comprehensive secondary manufacturing services, including quality assurance and compliance.

Regulatory and Compliance Considerations

Identifying suppliers necessitates ensuring adherence to applicable standards. All raw material and API suppliers, as well as finished product manufacturers, should possess current GMP certification. Suppliers must also align with the requirements of regulatory agencies such as the US Food & Drug Administration (FDA), European Medicines Agency (EMA), and other regional authorities.

Supply Chain Risks and Mitigation

Given COVID-19's impact on global supply chains, reliance on a limited pool of suppliers heightens risk. Companies manufacturing ADAGRASIB are diversifying sources and establishing dual sourcing agreements to secure uninterrupted supply and regulatory compliance. Strategic stockpiling and transparent supplier evaluations further mitigate potential disruptions.

Emerging Suppliers and Future Trends

Emerging biotech companies and contract manufacturing startups are entering the space, aiming to provide niche chemical synthesis and formulation capabilities. Digital supply chain tracking and blockchain technologies are increasingly employed to enhance traceability and compliance, vital for pharmaceuticals like ADAGRASIB that require precise manufacturing protocols.

Conclusion

The supply chain for ADAGRASIB involves a complex network of high-quality API and raw material suppliers, backed by reputable contract manufacturing organizations. Ensuring supply chain integrity hinges on rigorous supplier qualification, compliance adherence, and diversification to mitigate geopolitical and logistical risks. Stakeholders should monitor industry developments and supplier reliability metrics to maintain a resilient supply system for ADAGRASIB.

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Key Takeaways

• ADAGRASIB’s manufacturing relies on specialized API producers, notably Lonza, Thermo Fisher, Aenova, and CordenPharma.
• Raw material quality and supplier compliance are critical; all suppliers must adhere to GMP standards.
• Finished dosage form manufacturing is conducted by CMOs such as Pfizer, Sun Pharma, Catalent, and Famar.
• Supply chain robustness depends on diversification, regulatory compliance, and continuous risk assessment.
• Emerging manufacturing technologies and geopolitical factors influence future supplier dynamics.

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FAQs

1. Who are the primary API suppliers for ADAGRASIB?

Leading API manufacturing firms like Lonza, Thermo Fisher Scientific, Aenova Group, and CordenPharma are potential suppliers due to their expertise in complex molecule synthesis and GMP compliance.

2. Are there alternative suppliers for ADAGRASIB's raw materials?

Yes, companies such as Sigma-Aldrich and Santa Cruz Biotechnology provide chemical reagents and intermediates, serving as supplementary sources to mitigate supply chain risks.

3. Which contract manufacturing organizations produce ADAGRASIB's finished dosage forms?

Major CMOs include Pfizer Manufacturing Facilities, Sun Pharmaceutical Industries, Catalent Inc., and Famar, each offering capacity for oral solid dosage production with established quality standards.

4. What regulatory factors influence supplier selection for ADAGRASIB?

Suppliers must comply with GMP certifications, undergo regular audits, and align with FDA, EMA, and other international regulatory requirements to ensure drug safety and efficacy.

5. How are supply chain risks being managed for ADAGRASIB?

Strategies include diversifying supplier sources, engaging reputable CMOs, maintaining regulatory compliance, and leveraging digital tracking technologies to enhance transparency and contingency planning.

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References

[1] Lonza Group. https://www.lonza.com

[2] Thermo Fisher Scientific. https://www.thermofisher.com

[3] Aenova Group. https://www.aenova.com

[4] CordenPharma. https://www.cordenpharma.com

[5] Sigma-Aldrich. https://www.sigmaaldrich.com

[6] Pfizer Manufacturing. https://www.pfizer.com

[7] Sun Pharmaceutical Industries. https://www.sunpharma.com

[8] Recipharm. https://www.recipharm.com