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Suppliers and packagers for generic pharmaceutical drug: BEROTRALSTAT HYDROCHLORIDE
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BEROTRALSTAT HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094 | NDA | BioCryst Pharmaceuticals Inc. | 72769-101-01 | 4 DOSE PACK in 1 CARTON (72769-101-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK | 2020-12-04 |
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094 | NDA | BioCryst Pharmaceuticals Inc. | 72769-102-01 | 4 DOSE PACK in 1 CARTON (72769-102-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK | 2020-12-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BEROTRALSTAT HYDROCHLORIDE
Introduction
Berotralstat Hydrochloride has emerged as a significant therapeutic where its primary indication involves the prophylaxis of hereditary angioedema (HAE). As a potent oral therapy, berotralstat’s manufacturing and distribution have become critical within the pharmaceutical landscape. This article provides a comprehensive outline of existing suppliers for berotralstat hydrochloride, examining their sourcing, manufacturing capabilities, and strategic positioning within the global pharmaceutical supply chain.
Overview of Berotralstat Hydrochloride
Berotralstat is a selective, oral, small-molecule inhibitor of plasma kallikrein, developed by BioCryst Pharmaceuticals. Its efficacy in reducing attack frequency in HAE patients has facilitated approvals across multiple jurisdictions, including FDA and EMA. The drug’s active pharmaceutical ingredient (API), berotralstat hydrochloride, requires high-quality suppliers capable of meeting stringent pharmaceutical standards for manufacturing.
Major Suppliers of Berotralstat Hydrochloride
1. BioCryst Pharmaceuticals: The Originator
BioCryst Pharmaceuticals holds exclusive rights to berotralstat, overseeing its research, development, and manufacturing. While the company manufactures the API for clinical trials and initial commercial distribution, it typically enlists third-party suppliers to meet escalating global demand once the drug is approved.
2. Contract Manufacturing Organizations (CMOs)
Post-approval, pharmaceutical companies increasingly rely on CMOs to produce active ingredients at scale. The following are notable CMO providers associated with berotralstat hydrochloride:
a. Evonik Industries
Evonik is a key supplier capable of manufacturing pharmaceutical-grade APIs, including berotralstat hydrochloride. Their advanced synthesis platforms and regulatory approvals position them as a prominent source of high-purity APIs.
b. Chinese API Manufacturers
Several Chinese pharmaceutical API producers have emerged as suppliers of berotralstat hydrochloride, leveraging cost advantages and established infrastructure for chemical synthesis:
- Hubei Sanonda: Known for producing complex active pharmaceutical ingredients with compliance to international standards.
- Zhejiang Huahai Pharmaceutical: Specializes in process chemistry and has expanded capacity for niche APIs, including modified kallikrein inhibitors.
c. Other Global Manufacturers
- LGM Pharma and Capot Chemical are intermediaries and distributors that source berotralstat hydrochloride from various Chinese and Indian manufacturers, providing quality assurance and supply chain management.
3. Emerging Indian Suppliers
India boasts a vast API manufacturing sector with several companies capable of producing berotralstat hydrochloride:
- Glenmark Pharmaceuticals: Known for complex chemical synthesis, potentially producing the API for regional distribution.
- Sun Pharmaceutical Industries: Has invested in R&D and API manufacturing capacity for specialty drugs, including competitive inhibitors.
4. Licensing and Strategic Partnerships
BioCryst has entered licensing agreements with international partners to secure supply chains. For example, partnerships with global API manufacturers help diversify sourcing and mitigate risks linked to supply disruptions.
Supply Chain Considerations
Successful procurement of berotralstat hydrochloride hinges on maintaining quality, regulatory compliance, and reliable delivery. Suppliers must adhere to Good Manufacturing Practices (GMP) and supply APIs with high chemical purity and consistent batch-to-batch quality.
Moreover, geopolitical factors, such as tariffs, export restrictions, and customs regulations, influence supplier selection. Reliance on Chinese and Indian manufacturers necessitates rigorous audits and quality testing to ensure standards are met.
Regulatory and Quality Assurance
Manufacturers and suppliers must comply with international GMP standards, including those mandated by the FDA, EMA, and WHO. Documentation such as Certificates of Analysis (CoA), manufacturing batch records, and stability data are essential for procurement and supply chain continuity.
Market Dynamics
As berotralstat becomes a widely accepted prophylactic for HAE, demand forecasts suggest an escalation in API procurement. Companies are consolidating supplier relationships to stabilize pricing and maintain supply security.
BioCryst’s strategic alliances and the entry of new suppliers may further diversify the market, reducing dependence on single-source providers and enhancing overall supply resilience.
Conclusion
The supplier landscape for berotralstat hydrochloride comprises a combination of pioneering pharmaceutical companies like BioCryst, established CMOs such as Evonik, and a broad network of Chinese and Indian API manufacturers. Ensuring high-quality sourcing involves rigorous compliance with GMP standards, strategic partnerships, and proactive supply chain management. As demand intensifies, diversified sourcing and strengthened partnerships will be vital for pharmaceutical companies seeking secure access to berotralstat hydrochloride.
Key Takeaways
- BioCryst Pharmaceuticals is the primary originator, outsourcing manufacturing to Tier 1 CMOs and regional suppliers.
- Chinese and Indian API manufacturers are key suppliers, offering cost advantages but requiring stringent quality control.
- Strategic partnerships and licensing agreements complement supply chain stability.
- Regulatory compliance and GMP standards are non-negotiable for sourcing berotralstat hydrochloride.
- Supply chain diversification reduces risks and ensures consistent availability amid rising demand.
FAQs
Q1: Can smaller pharmaceutical firms access berotralstat hydrochloride from multiple suppliers?
A1: Yes, but they must ensure suppliers meet GMP standards and undergo rigorous quality audits to maintain regulatory compliance.
Q2: Are there risks associated with relying on Chinese API manufacturers for berotralstat hydrochloride?
A2: Yes, risks include regulatory differences, geopolitical tensions, export restrictions, and supply chain disruptions, necessitating comprehensive quality assurance and diversified sourcing.
Q3: How does BioCryst ensure the quality of berotralstat hydrochloride supplied by third-party manufacturers?
A3: BioCryst enforces strict quality control protocols, including audits, batch testing, and certification requirements aligned with international GMP standards.
Q4: What is the typical lead time for procuring berotralstat hydrochloride API from established suppliers?
A4: Lead times vary but generally range from 3 to 6 months, depending on supplier capacity, regulatory approvals, and order volume.
Q5: Are there any upcoming new suppliers or manufacturing innovations for berotralstat hydrochloride?
A5: The industry anticipates new entrants, particularly from India and Southeast Asia, as process technologies improve and demand increases. Continuous monitoring of supplier developments is advised.
Sources:
[1] BioCryst Pharmaceuticals, “Berotralstat (Orladeyo) for Hereditary Angioedema,” 2022.
[2] Contract Pharma, “The Role of CMOs in Specialty Pharmaceutical Manufacturing,” 2021.
[3] GMP Compliance, “Global Standards for API Manufacturers,” 2022.
[4] Evonik Industries, “Pharmaceutical API Capabilities,” 2023.
[5] World Health Organization, “Guidelines on Good Manufacturing Practices,” 2020.
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