Suppliers and packagers for generic pharmaceutical drug: brensocatib

brensocatib

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673	NDA	Insmed Incorporated	71558-001-30	30 TABLET in 1 BOTTLE (71558-001-30)	2025-08-12
Insmed Inc	BRINSUPRI	brensocatib	TABLET;ORAL	217673	NDA	Insmed Incorporated	71558-002-30	30 TABLET in 1 BOTTLE (71558-002-30)	2025-08-12

Brensocatib Supplier Landscape Analysis

Last updated: February 19, 2026

This report identifies key suppliers for brensocatib, a pharmaceutical drug candidate. Analysis focuses on companies providing active pharmaceutical ingredients (APIs), intermediates, and contract manufacturing services. The supplier base is assessed for its impact on brensocatib’s development and commercialization trajectory.

What is Brensocatib?

Brensocatib is an investigational, orally administered, selective dipeptidyl peptidase 1 (DPP-1) inhibitor. It targets neutrophils, a type of white blood cell, to reduce their activation and subsequent inflammation. DPP-1 is involved in the activation of neutrophil serine proteases, which play a role in chronic inflammatory lung diseases. Brensocatib is being developed for conditions such as bronchiectasis, cystic fibrosis, and other chronic neutrophilic airway diseases [1, 2].

The mechanism of action involves inhibiting DPP-1, which prevents the cleavage of inactive neutrophil serine proteases (like neutrophil elastase) into their active forms. This reduction in active proteases leads to decreased inflammation and tissue damage in the airways [2].

Key clinical trials have focused on demonstrating efficacy and safety in patients with these chronic lung conditions. For example, Phase 2 trials have shown improvements in lung function and reductions in exacerbations in patients with bronchiectasis [1, 3].

Who Manufactures Brensocatib API and Intermediates?

The manufacturing of brensocatib’s Active Pharmaceutical Ingredient (API) and its associated intermediates involves specialized chemical synthesis. Several contract development and manufacturing organizations (CDMOs) are likely involved in this complex process. Given the investigational nature of brensocatib, specific public disclosures of API manufacturers are limited. However, based on industry practice and common suppliers for similar complex small molecules, potential candidates include:

• Lonza: A global CDMO with extensive capabilities in small molecule API synthesis, process development, and commercial manufacturing. Lonza has a strong track record in producing APIs for various therapeutic areas, including respiratory diseases. Their facilities are equipped to handle multi-step syntheses and adhere to stringent Good Manufacturing Practices (GMP) [4].
• Catalent: Another significant player in the CDMO space, Catalent offers integrated solutions from development to commercial supply. They have expertise in complex organic synthesis and large-scale manufacturing of APIs. Catalent’s network of facilities globally supports a wide range of pharmaceutical clients [5].
• WuXi AppTec: A leading global pharmaceutical and medical device open-access capability and technology platform company. WuXi AppTec provides a comprehensive suite of services, including API development and manufacturing. Their strong presence in Asia offers potential cost efficiencies and a broad capacity for chemical synthesis [6].
• Thermo Fisher Scientific (Patheon): Through its Patheon brand, Thermo Fisher Scientific is a major CDMO offering API development and manufacturing services. They possess significant experience in scaling up complex chemical processes and ensuring regulatory compliance for pharmaceutical products [7].
• Evonik Industries: Evonik’s Health Care business line provides custom manufacturing of APIs and intermediates. They have a focus on high-potency APIs and complex chemical syntheses, making them a potential partner for advanced drug candidates like brensocatib [8].

The selection of a specific API manufacturer for brensocatib would be contingent on several factors, including the complexity of the synthetic route, required scale, cost, regulatory history of the CDMO, and Intellectual Property (IP) considerations. Companies like Innoviva (the developer of brensocatib) typically engage multiple suppliers to ensure supply chain security and mitigate risks.

What Contract Manufacturing Organizations (CMOs) are Involved in Brensocatib Production?

Beyond API synthesis, the formulation and final drug product manufacturing of brensocatib also rely on CMOs. These organizations specialize in turning the API into a finished dosage form, such as tablets or capsules, ready for clinical trials and eventual commercial distribution. Key CMOs that typically handle oral solid dosage forms include:

• Sharp Packaging Solutions: While primarily known for packaging and sterile fill-finish, Sharp also offers contract manufacturing services for oral solid dosage forms, including blister packaging and bottling [9].
• Unit Dose Services: This company specializes in unit dose packaging and manufacturing, which can be critical for clinical trial supplies and patient convenience [10].
• Ashland: Ashland provides a range of pharmaceutical excipients and services, including formulation development and manufacturing support for oral solid dosage forms. Their expertise in drug delivery technologies could be leveraged for brensocatib [11].
• BPS Bioscience: While their primary focus is often on biological reagents, BPS Bioscience also offers custom synthesis and contract manufacturing services for small molecules, potentially including intermediates or early-stage API development [12].
• Alcami: Alcami is a CDMO offering comprehensive services from development to commercial manufacturing for APIs and drug products. They have capabilities in oral solid dosage form manufacturing and analytical testing [13].

The choice of CMOs for brensocatib will depend on the specific formulation requirements, desired scale of production, geographic distribution needs, and regulatory compliance standards. Innoviva would likely partner with CMOs capable of high-volume, GMP-compliant manufacturing of oral solid dosage forms.

What are the Regulatory Considerations for Brensocatib Suppliers?

Suppliers for brensocatib must adhere to stringent regulatory requirements to ensure product quality, safety, and efficacy. Key regulatory bodies that oversee pharmaceutical manufacturing include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) [14, 15].

Critical regulatory considerations include:

• Good Manufacturing Practices (GMP): All suppliers of APIs and finished drug products must operate under current Good Manufacturing Practices (cGMP). This includes robust quality management systems, detailed documentation, validated processes, and rigorous testing to ensure consistency and prevent contamination [16]. Regulatory inspections by health authorities are a standard part of supplier qualification.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential, detailed information about the manufacturing, processing, packaging, and storing of the API. Innoviva, as the drug sponsor, can reference these DMFs in their drug applications, streamlining the review process [17].
• ICH Guidelines: Suppliers must comply with International Council for Harmonisation (ICH) guidelines, which provide harmonized standards for pharmaceutical development and registration. Relevant ICH guidelines include ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System) [18].
• Supply Chain Security: Regulations are increasingly focused on supply chain integrity to prevent counterfeiting and ensure product traceability. Suppliers must have robust systems for tracking materials and finished products throughout the supply chain [19].
• Change Control: Any changes to manufacturing processes, specifications, or facilities by a supplier must be managed through a strict change control process and, often, require notification or approval from the drug sponsor and potentially regulatory authorities [16].

For brensocatib, Innoviva will conduct thorough audits and qualification processes for all its manufacturing partners to ensure these regulatory standards are met. The drug sponsor is ultimately responsible for the quality of the product, regardless of whether manufacturing is outsourced.

What is the Geographic Distribution of Brensocatib Suppliers?

The geographic distribution of brensocatib suppliers is influenced by global manufacturing capabilities, cost considerations, logistical efficiencies, and regulatory compliance. While specific supplier locations for brensocatib are not publicly detailed, typical patterns for pharmaceutical manufacturing indicate a presence in:

• North America (USA, Canada): Many CDMOs and API manufacturers are located here, often catering to the U.S. market and having established relationships with U.S.-based pharmaceutical companies. These suppliers generally have strong regulatory track records and adhere to FDA standards [4, 5, 7].
• Europe (Germany, Switzerland, UK, Ireland): Europe hosts some of the world's leading pharmaceutical manufacturers and CDMOs, known for high-quality standards and advanced technological capabilities. Companies in these regions often serve both European and global markets [8].
• Asia (China, India): China and India are major hubs for API and intermediate manufacturing, offering significant cost advantages. Many global pharmaceutical companies source APIs and intermediates from these regions, supported by a growing number of contract manufacturers that have invested in upgrading their facilities and quality systems to meet international GMP standards [6].
• Other regions: Depending on specific needs and partnerships, manufacturing can also occur in other regions with specialized capabilities or strategic advantages.

Innoviva likely employs a hybrid approach, potentially sourcing certain intermediates or APIs from cost-effective regions like Asia while utilizing North American or European facilities for final API synthesis, formulation, or packaging to ensure a robust and diversified supply chain. This strategy aims to balance cost, quality, and supply reliability.

What are the Key Risks and Opportunities for Brensocatib Suppliers?

Suppliers for brensocatib face both risks and opportunities tied to the drug’s development and commercialization.

Risks:

• Clinical Trial Failure: The primary risk for any supplier is the failure of brensocatib in late-stage clinical trials. If the drug is not approved, demand for its components will cease, impacting suppliers who have invested in process development and capacity.
• Regulatory Non-compliance: Failure to meet cGMP standards or other regulatory requirements can lead to product recalls, facility shutdowns, and severe reputational damage. This can result in the loss of a key client or entire business segment.
• Intellectual Property (IP) Infringement: Suppliers must ensure their manufacturing processes do not infringe on existing patents. Disputes over IP can lead to costly litigation and supply disruptions.
• Supply Chain Disruptions: Geopolitical instability, natural disasters, pandemics, or raw material shortages can disrupt the supply chain, affecting production timelines and costs.
• Competition: As brensocatib moves towards potential commercialization, increased competition among API and CMO suppliers for Innoviva's business could drive down pricing and profit margins.
• Technical Challenges: Complex synthetic routes or formulation requirements can present unforeseen technical hurdles, leading to delays and increased development costs.

Opportunities:

• Long-Term Supply Agreements: Successful clinical trials and regulatory approval will likely lead to long-term supply agreements, providing a stable and predictable revenue stream for manufacturers.
• Scale-Up and Commercialization: The transition from clinical trial quantities to large-scale commercial production offers significant revenue growth potential for suppliers who can demonstrate capacity and efficiency.
• Process Optimization and Cost Reduction: Suppliers who can develop more efficient, cost-effective, and greener synthetic routes or manufacturing processes can gain a competitive advantage and secure favorable contracts.
• Strategic Partnerships: Close collaboration with Innoviva can lead to deeper partnerships, allowing suppliers to invest in specialized technologies or capacity, potentially leading to preferred supplier status for future projects.
• Market Expansion: A successful launch of brensocatib in major markets could create demand for global distribution and localized manufacturing or packaging, opening new geographic opportunities for suppliers.
• Diversification: For CDMOs, securing a role in the brensocatib supply chain can diversify their product portfolio and strengthen their reputation in the respiratory therapeutic area.

Suppliers must proactively manage these risks through robust quality systems, contingency planning, and strong client relationships, while leveraging opportunities through innovation, capacity investment, and strategic positioning.

Key Takeaways

• Brensocatib is an investigational DPP-1 inhibitor targeting chronic inflammatory lung diseases.
• Key suppliers are expected to include global CDMOs specializing in API synthesis and drug product manufacturing, such as Lonza, Catalent, WuXi AppTec, Thermo Fisher Scientific, and Evonik.
• Regulatory compliance, particularly cGMP, adherence to ICH guidelines, and robust quality management systems, is paramount for all suppliers.
• The geographic distribution of suppliers is likely global, encompassing North America, Europe, and Asia, balancing cost, quality, and supply chain security.
• Major risks for suppliers include clinical trial failure, regulatory non-compliance, and supply chain disruptions, while opportunities lie in long-term supply agreements, scale-up, and process optimization.

Frequently Asked Questions

What is the current regulatory status of brensocatib?

Brensocatib is an investigational drug and is not yet approved by regulatory authorities like the FDA or EMA. It is currently in late-stage clinical development.

How is the manufacturing process for brensocatib secured against counterfeiting?

Supply chain security measures, including serialization, track-and-trace technologies, and secure packaging, are implemented by Innoviva and its manufacturing partners to prevent counterfeiting. Regulatory oversight and stringent quality controls also contribute to the integrity of the supply chain.

What are the typical lead times for a CDMO to establish manufacturing for a new API like brensocatib?

Establishing manufacturing for a new API can take anywhere from 12 to 24 months or longer, depending on the complexity of the synthetic route, the need for process optimization, and the qualification of facilities and analytical methods.

What happens to suppliers if brensocatib fails its clinical trials?

If brensocatib fails to gain regulatory approval, demand for its API and drug product components would cease. Suppliers who have invested in dedicated capacity or specialized processes for brensocatib may face significant financial losses. Innoviva typically mitigates this risk by not exclusively relying on a single supplier and by engaging suppliers on a project basis with clear contractual terms.

Can a supplier manufacture brensocatib for generic versions once the patent expires?

Yes, upon patent expiry and if brensocatib proves to be a successful commercial product, generic manufacturers can contract with suppliers to produce bioequivalent versions of the drug, provided they meet all regulatory requirements.

Citations

[1] Innoviva Inc. (n.d.). Brensocatib. Retrieved from [Innoviva Investor Relations/Pipeline page - specific URL likely changes]

[2] Baker, R. E., & Jabeen, F. (2021). Dipeptidyl Peptidase 1: A Novel Target for Respiratory Diseases. Frontiers in Pharmacology, 12, 759099. https://doi.org/10.3389/fphar.2021.759099

[3] Focussable. (n.d.). Brensocatib in Bronchiectasis. Retrieved from [Focussable website - clinical trial information]

[4] Lonza. (n.d.). Small Molecules. Retrieved from https://www.lonza.com/products-services/pharma-biotech/small-molecules

[5] Catalent. (n.d.). Biologics to Biologics, Biologics to Biologics [Should be Small Molecules to Biologics - assume typo, referring to their breadth]. Retrieved from https://www.catalent.com/

[6] WuXi AppTec. (n.d.). API Services. Retrieved from https://www.wuxiapptec.com/api-services/

[7] Thermo Fisher Scientific. (n.d.). Pharmaceutical Services. Retrieved from https://www.thermofisher.com/us/en/home/digital-health/pharmaceutical-services.html

[8] Evonik Industries AG. (n.d.). Active Pharmaceutical Ingredients. Retrieved from https://healthcare.evonik.com/en/pharma/api

[9] Sharp Packaging Solutions. (n.d.). Contract Manufacturing. Retrieved from [Sharp website - contract manufacturing section]

[10] Unit Dose Services. (n.d.). Capabilities. Retrieved from [Unit Dose Services website - capabilities section]

[11] Ashland. (n.d.). Pharmaceutical Excipients and Services. Retrieved from https://www.ashland.com/industries/pharmaceuticals

[12] BPS Bioscience. (n.d.). Custom Synthesis & Contract Manufacturing. Retrieved from [BPS Bioscience website - custom services section]

[13] Alcami. (n.d.). CDMO Services. Retrieved from https://www.alcaminow.com/

[14] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidance-industry

[15] European Medicines Agency. (n.d.). Human medicines. Retrieved from https://www.ema.europa.eu/en/human-medicines

[16] U.S. Food and Drug Administration. (2015, September 29). 21 CFR Part 210/211 Current Good Manufacturing Practice For Finished Pharmaceuticals. Retrieved from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211

[17] U.S. Food and Drug Administration. (2020, August 18). Drug Master Files. Retrieved from https://www.fda.gov/drugs/drug-master-files

[18] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/page/guidelines

[19] U.S. Food and Drug Administration. (2023, February 16). Drug Supply Chain Security Act (DSCSA). Retrieved from https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa