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Suppliers and packagers for MYRBETRIQ GRANULES
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MYRBETRIQ GRANULES
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801 | NDA | Astellas Pharma US, Inc. | 0469-5020-99 | 1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE | 2021-03-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MYRBETRIQ GRANULES
Introduction
MYRBETRIQ GRANULES, marketed under the generic name Mirabegron, is an oral β3-adrenoceptor agonist used primarily for the treatment of overactive bladder (OAB) with symptoms of urinary urgency, frequency, and incontinence. As a relatively recent addition to OAB pharmacotherapy, securing reliable suppliers is essential for healthcare providers, pharmacies, and procurement agencies aiming to ensure drug availability, quality, and affordability.
This article offers a comprehensive overview of the key suppliers of MYRBETRIQ GRANULES, exploring manufacturing origins, distribution networks, regulatory statuses, and market dynamics vital for informed procurement and strategic planning.
Manufacturers and Brand Origin
AstraZeneca, the original developer and owner of MYRBETRIQ, is the primary manufacturer of Mirabegron-based formulations, including MYRBETRIQ GRANULES. Launched globally following regulatory approvals, AstraZeneca’s manufacturing facilities in various regions (notably Europe and the United States) produce the active pharmaceutical ingredient (API) and finished drug products.
AstraZeneca’s Role
AstraZeneca maintains strict quality controls and complies with international Good Manufacturing Practices (GMP), ensuring the pharmacological efficacy and safety of MYRBETRIQ GRANULES. The company's extensive distribution network spans North America, Europe, Asia, and other markets, making it a predominant supplier for authorized versions globally.
Key points:
- AstraZeneca’s proprietary manufacturing ensures consistent API quality.
- They hold patents and exclusive rights for MYRBETRIQ in certain territories.
- The company licenses manufacturing in specific markets to approved third-party firms.
Authorized Generic Manufacturers
In some regions, authorized generics of MYRBETRIQ GRANULES are produced under AstraZeneca’s license agreements with local pharmaceutical companies. These include:
- Zhejiang Huahai Pharmaceutical Co., Ltd. (China): Licensed manufacturer for generic versions in China, adhering to local GMP standards.
- Accord Healthcare (India): Produces generic Mirabegron formulations for the Indian and South Asian markets, closely aligned with AstraZeneca’s formulations.
- Mylan (now part of Viatris): Historically involved in generic production, though their role in MYRBETRIQ specifically has evolved with market licenses.
These manufacturers provide more cost-effective alternatives, expanding access, especially in emerging markets.
Global Market and Key Distributors
The distribution of MYRBETRIQ GRANULES spans multiple regions, facilitated by strategic partnerships and authorized distributors:
| Region | Main Suppliers and Distributors | Regulatory Status | Notes |
|---|---|---|---|
| North America (U.S., Canada) | AstraZeneca, authorized generics via Teva Pharmaceuticals | Approved by FDA (U.S.) and HC (Canada) | Distribution channels include hospital pharmacies, retail chains, and specialty pharmacies. |
| Europe | AstraZeneca’s European facilities, authorized generics through local licensees | EMA approval (European Medicines Agency) | Distribution through national health authorities and private pharmacies. |
| Asia-Pacific | AstraZeneca licensing agreements, local manufacturers (e.g., Zhejiang Huahai) | Regulatory approvals vary by country | Growing market, with local manufacturing increasing accessibility. |
| Latin America | Local licensed suppliers, regional distributors | Varies by country | Market expansion driven by regulatory approvals and local collaborations. |
Regulatory and Licensing Trends
AstraZeneca’s patent protections for MYRBETRIQ have prompted generic manufacturers to seek licensing agreements or develop formulations once exclusivity periods expire. These arrangements facilitate broader supply and reduce drug costs but also influence supplier diversity.
In the U.S., Mirabegron was approved by the FDA in 2012, leading to the availability of branded and generic versions. The FDA’s Orange Book lists multiple approved generics, indicating a competitive procurement environment—essential for healthcare systems seeking budget-efficient options.
European agencies have similarly approved generic Mirabegron formulations, with local manufacturers authorized under marketing authorization applications (MAAs). In emerging markets, regulatory pathways may be less centralized, but licensed production is increasing with growing demand.
Market Dynamics and Key Supplier Considerations
- Quality Assurance: Suppliers must adhere to strict GMP standards to meet regulatory compliances and ensure drug safety.
- Supply Stability: Manufacturers with diversified production facilities reduce risks of shortages.
- Cost-Effectiveness: Authorized generics typically offer more affordable options while maintaining efficacy.
- Regulatory Approvals: Suppliers with timely approvals in target markets ensure rapid availability of MYRBETRIQ GRANULES.
- Partnerships and Licensing Agreements: Strategic collaborations influence the availability and pricing of the drug.
Emerging Suppliers and Future Outlook
As patents for MYRBETRIQ approach expiration in key markets, the landscape is expected to diversify further:
- Additional Generics: Several pharmaceutical companies are preparing to seek approval for Mirabegron generics, with expected emergence of new suppliers.
- Local Manufacturing: Increasing investments in regional production facilities aim to meet domestic demand and reduce reliance on imports.
- Biosimilar and Alternative Formulations: Though Mirabegron is small-molecule, ongoing research may yield formulations that influence future supply chains.
Key Takeaways
- AstraZeneca remains the primary supplier and quality leader for MYRBETRIQ GRANULES, with licensed generics contributing significantly to supply diversity.
- Generic manufacturers in Asia and emerging markets expand access but require thorough vetting for quality and regulatory compliance.
- Regulatory approvals are crucial indicators of supplier reliability; authorized generics typically offer more affordable and accessible options.
- Supply chain resilience relies on manufacturers with diversified production facilities and strategic licensing agreements.
- Market evolution suggests increased competition and variety in suppliers following patent expiry, which could benefit healthcare providers through cost reduction.
FAQs
1. Who are the primary manufacturers of MYRBETRIQ GRANULES?
AstraZeneca is the original manufacturer of MYRBETRIQ (Mirabegron), with licensed generic producers in various regions, including Zhejiang Huahai in China and Accord Healthcare in India.
2. Are generic versions of MYRBETRIQ equally effective?
Yes. Approved generic Mirabegron formulations meet regulatory standards and are bioequivalent to branded MYRBETRIQ, providing similar clinical outcomes.
3. How does patent expiry influence supplier availability?
Patent expiration allows for the entry of generic manufacturers, increasing supply options, reducing costs, and diversifying the supply chain.
4. What should healthcare providers consider when selecting a supplier?
Providers should prioritize suppliers with GMP compliance, regulatory approval in their jurisdiction, reliable distribution networks, and positive quality track records.
5. Is MYRBETRIQ GRANULES safe to import from emerging markets?
Only if the product has valid regulatory approval in your country and comes from a licensed, GMP-compliant manufacturer. Verification of certification and authenticity is critical.
References
- AstraZeneca. (2023). MYRBETRIQ (Mirabegron) official prescribing information.
- U.S. Food and Drug Administration (FDA). (2012). Mirabegron approval details [Orange Book].
- European Medicines Agency (EMA). (2022). European approval summaries for Mirabegron.
- Zhejiang Huahai Pharmaceutical Co., Ltd. official website.
- Accord Healthcare. (2023). Product portfolio and licensing details.
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