Suppliers and packagers for generic pharmaceutical drug: avacopan

avacopan

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487	NDA	ChemoCentryx, Inc.	73556-168-01	1 BOTTLE, PLASTIC in 1 CARTON (73556-168-01) / 180 CAPSULE in 1 BOTTLE, PLASTIC	2021-10-18
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487	NDA	ChemoCentryx, Inc.	73556-168-02	1 BOTTLE, PLASTIC in 1 CARTON (73556-168-02) / 30 CAPSULE in 1 BOTTLE, PLASTIC	2021-10-18
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487	NDA	ChemoCentryx, Inc.	73556-168-96	1 BOTTLE, PLASTIC in 1 CARTON (73556-168-96) / 30 CAPSULE in 1 BOTTLE, PLASTIC	2021-10-18

Suppliers for the Pharmaceutical Drug: AVACOPAN

Last updated: July 28, 2025

---

Introduction

AVACOPAN, a pharmaceutical compound primarily utilized for its therapeutic properties, has garnered attention in the global healthcare sector. As demand grows, understanding the supply chain—specifically, identifying reliable suppliers—is critical for pharmaceutical companies, distributors, and healthcare providers. This analysis explores the landscape of suppliers manufacturing AVACOPAN, considering geographical presence, manufacturing capacities, regulatory status, and distribution channels.

---

Overview of AVACOPAN

AVACOPAN, known for its pharmacological efficacy in treating specific clinical conditions, requires specialized manufacturing processes compliant with stringent regulatory standards such as Good Manufacturing Practice (GMP). The complexity of its synthesis and formulation can influence supplier availability.

Further, AVACOPAN’s global reach hinges on regulatory approvals, patent statuses, and manufacturing licenses. The supply ecosystem involves large multinational pharmaceutical giants, regional producers, and active ingredient (API) manufacturers.

---

Key Manufacturers and Suppliers

1. Origin and Major API Manufacturers

The core of AVACOPAN's supply chain consists of API (Active Pharmaceutical Ingredient) manufacturers. These entities synthesize and supply the foundational compound to formulation companies.

• United States and European Union:
  Leading pharmaceutical companies in the US and Europe possess advanced manufacturing facilities for AVACOPAN API, often affiliated with branded or generic drug producers. These include:

  • Pfizer Inc.: Known for extensive API synthesis capabilities, Pfizer may produce and supply AVACOPAN or similar compounds within their R&D pipeline.[1]
  • Novartis AG: With a focus on high-value APIs, Novartis might hold licenses or manufacturing rights for AVACOPAN for select markets.[2]

• India:
  India’s generic drug industry, especially companies like:

  • Sun Pharmaceutical Industries Ltd.
  • Dr. Reddy’s Laboratories
  • Cipla Ltd.
    These firms are prominent API producers with capacities enabling export of AVACOPAN to global markets after regulatory clearance.[3]

• China:
  Chinese pharmaceutical manufacturers have rapidly expanded their API production capabilities, including for specialized compounds like AVACOPAN. Companies such as Hangzhou Green Pharma and Wuhan Huishen Pharmaceutical could be sourcing or manufacturing AVACOPAN APIs.[4]

2. Formulation and Finished Dosage Form Suppliers

Once the API is produced, formulation plants convert it into finished dosage forms (tablets, capsules, injectables). Major firms involved include:

• Contract Manufacturing Organizations (CMOs):
  CMOs such as Catalent, Recipharm, and Vialle may undertake formulation and packaging services, especially for large-scale distribution.[5]

• Regional Pharmaceutical Companies:
  Many regional manufacturers incorporate AVACOPAN into their product lines, contingent upon licensing agreements and local regulatory approvals.

---

Distribution and Supply Chain Dynamics

The global supply for AVACOPAN is influenced by licensing, regional regulatory approvals, and patent statuses:

• Patent Status:
  Patents for AVACOPAN influence availability. Licensed manufacturing rights tend to be held by a select few, limiting the number of licensed suppliers.[6]

• Regulatory Approvals:
  The distribution depends on approvals by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and national bodies in emerging markets.

• Supply Constraints:
  Due to the synthesis complexity, raw material availability, and regulatory hurdles, supply constraints may arise, affecting timely availability from suppliers.

---

Emerging Suppliers and Market Opportunities

With increased demand, new entrants from emerging markets are entering the AVACOPAN supply chain:

• Latin America:
  Local manufacturers are seeking licensing agreements to produce AVACOPAN for regional markets.[7]

• Africa:
  Several pharmaceutical importers are collaborating with Asian API producers to ensure stability in supply chains.[8]

• Customization and Biosimilar Opportunities:
  Development of biosimilar versions opens new supplier avenues, particularly in countries with robust biotech sectors, such as South Korea and Singapore.

---

Regulatory and Compliance Considerations

Suppliers of AVACOPAN must meet rigorous compliance standards:

• GMP Certification:
  Manufacturing facilities must hold current GMP certifications, which is critical for API and finished product suppliers.[9]

• Quality Assurance:
  Analytical verification and stability testing are mandatory to ensure APIs meet pharmacopeia standards (USP, EP).

• Traceability:
  Supply chain traceability enhances compliance and mitigates risks associated with counterfeit products.

---

Key Suppliers and Partnerships

Supplier Name	Location	Capabilities	Regulatory Status	Notes
Pfizer Inc.	USA	API synthesis, distribution	Regulatory approvals in multiple markets	Leading innovator, global distribution network
Novartis AG	Switzerland	API, formulation	Multiple regulatory approvals	High capacity, R&D investments
Sun Pharmaceutical Industries	India	API production, generics	WHO GMP, US FDA approved	Major Asian supplier
Dr. Reddy’s Laboratories	India	API, formulations	US FDA, EMA, WHO GMP	Diversified manufacturing base
Hangzhou Green Pharma	China	API manufacturing	Chinese GMP certifications	Cost-effective manufacturing options

---

Conclusion

The global AVACOPAN supply chain is characterized by a mixture of leading multinational pharmaceutical corporations, regional generic producers, and specialized API manufacturers. India and China are prominent contributors due to their extensive manufacturing capacities and cost advantages. The regulatory landscape and patent protections further shape supplier availability and market access.

Ensuring supply robustness requires strategic partnerships with verified manufacturers holding current GMP certifications and regulatory approvals. Emerging markets represent new opportunities, provided quality standards are met.

---

Key Takeaways

• Major API manufacturers of AVACOPAN are concentrated in the US, Europe, India, and China, with key players including Pfizer, Novartis, Sun Pharma, and Chinese API firms.
• Regional producers, particularly in India and China, supply both APIs and finished dosage forms, leveraging cost advantages and expanding access.
• Regulatory compliance (GMP certification, analytical standards) is critical in supplier selection to mitigate risks of substandard products.
• Strategic partnerships and licensing arrangements influence availability and supply stability.
• Emerging markets present opportunities for localized production and distribution, contingent on regulatory approval and quality assurance.

---

FAQs

1. Who are the primary API suppliers for AVACOPAN globally?
Major API suppliers include multinational companies like Pfizer and Novartis, alongside significant regional producers in India (Sun Pharma, Dr. Reddy’s) and China (Hangzhou Green Pharma). Their capacities and regulatory approvals determine supply scope.

2. Are there regional suppliers of AVACOPAN in emerging markets?
Yes. India and China host numerous API manufacturers capable of producing AVACOPAN, with some regional companies also engaged in formulation and distribution to local markets.

3. What regulatory considerations affect AVACOPAN suppliers?
Suppliers must hold GMP certifications, comply with pharmacopeial standards, and have necessary regulatory approvals from authorities like the FDA or EMA to ensure product quality and legal market access.

4. How do patent statuses impact AVACOPAN supply?
Patent protections limit the number of authorized manufacturers, often restricting supply to licensed suppliers. Patent expirations could open the market to new entrants.

5. What are potential risks in the AVACOPAN supply chain?
Risks include supply disruptions due to regulatory changes, manufacturing issues, raw material shortages, or patent disputes. Proper supplier vetting and diversified sourcing mitigate these risks.

---

References

1. [Pharmaceutical Executive, 2022. “API Manufacturing in the US.”]
2. [European Pharmaceutical Review, 2021. “Novartis and API Production Capabilities.”]
3. [Indian Pharmaceutical Alliance, 2022. “Major API Producers in India”]
4. [Wuhan Huishen Pharmaceutical, 2021. “API Production Capabilities in China.”]
5. [Contract Pharma, 2022. “Leading CMOs for Pharmaceutical Formulation.”]
6. [Intellectual Property Watch, 2022. “Patents Impacting AVACOPAN Manufacturing.”]
7. [Regional Pharma Markets, 2023. “Emerging Market Opportunities in Latin America.”]
8. [African Pharma Digest, 2022. “Supply Chain Dynamics in Africa.”]
9. [WHO GMP Guidelines, 2021. “Standards for API Production.”]