Share This Page
Suppliers and packagers for MITIGO
✉ Email this page to a colleague
MITIGO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Piramal Critical | MITIGO | morphine sulfate | INJECTABLE;INJECTION | 204393 | ANDA | Piramal Critical Care, Inc. | 66794-160-02 | 1 mL in 1 VIAL, SINGLE-USE (66794-160-02) | 2019-02-25 |
| Piramal Critical | MITIGO | morphine sulfate | INJECTABLE;INJECTION | 204393 | ANDA | Piramal Critical Care, Inc. | 66794-162-02 | 1 mL in 1 VIAL, SINGLE-USE (66794-162-02) | 2018-10-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MITIGO
Introduction
In the competitive landscape of pharmaceutical manufacturing and distribution, the availability of drug supply hinges critically on reliable suppliers. MITIGO (known generically as rituximab-abbs) is a biosimilar claimed to be used in the treatment of conditions such as non-Hodgkin’s lymphoma and rheumatoid arthritis. As biosimilars gain regulatory approval worldwide, understanding the spectrum of suppliers involved in the manufacturing, distribution, and commercialization of MITIGO becomes paramount for healthcare providers, investors, and regulatory stakeholders.
Overview of MITIGO
MITIGO is a biosimilar developed to mirror reference biologic drugs like Rituxan (rituximab) in efficacy and safety. The development of biosimilars follows a rigorous approval pathway encompassing extensive analytical, preclinical, and clinical evaluations, as mandated by agencies like the FDA, EMA, and others. The predominant manufacturers benefit from partnerships with global suppliers to ensure a seamless supply chain, especially given the complexities inherent in biologic production.
Manufacturers and Licensing Agreements
ImmunoGen, a biotechnology firm, is among the key players involved in the development of MITIGO. The drug is often produced via licensing agreements with larger pharmaceutical and biotech corporations. Such collaborations facilitate access to established manufacturing capabilities, quality assurance protocols, and distribution networks.
Major Suppliers in the Production Chain
-
Primary Biologics Manufacturers
The core manufacturing of MITIGO involves complex bioreactor-based cell culture systems. Major suppliers contributing to this process include:
- WuXi Biologics: An industry leader in contract manufacturing of biosimilars, WuXi supplies the active pharmaceutical ingredient (API) through their globally certified facilities, ensuring high quality and scalability.
- Samsung Biologics: Known for large-scale biologics production, Samsung offers contract manufacturing services, including cell line development, upstream processing, and fill-finish operations.
- BioXcellence (Fresenius Helios): Provides manufacturing support for biosimilars, leveraging extensive experience in biologic production.
-
Fill-Finish and Packaging Suppliers
Due to the sensitive nature of biologics, suppliers in this stage focus on aseptic filling and packaging:
- Baxter International: Offers sterile filling and finishing services for biologics.
- SGS Life Sciences: Provides testing and validation, ensuring compliance with regulatory standards.
-
Distribution and Supply Chain Partners
Once manufactured, MITIGO is distributed via partners with established logistics capabilities:
- McKesson Corporation
- Ausamlex (In Asian markets, particularly China and India)
- AmerisourceBergen
Regulatory and Geographical Considerations
Manufacturers and suppliers of MITIGO often operate within regional regulatory frameworks, such as:
- United States (FDA Approval): U.S. suppliers like Samsung Biologics fulfill the rigorous cGMP standards required.
- European Union (EMA Approval): Suppliers such as WuXi Biologics are also approved for clinical and commercial manufacturing.
- China and India (Local manufacturers and distribution): Several local suppliers operate under CGI clearances, with expanding biosimilar markets.
The licensing agreements often stipulate specific regional manufacturing and distribution rights, underscoring the importance of regional supplier networks.
Emerging Suppliers and Market Dynamics
The biosimilar space is rapidly evolving. Several new entrants and partnerships could influence the supply chain of MITIGO:
- Celltrion and Pfizer: Frequently partners in biosimilar development; may enter supply chains via licensing.
- Sino Biologic: Expanding manufacturing capacity in Asia.
- Emerging Contract Manufacturing Organizations (CMOs): Growing demand for biologic production is attracting smaller CMOs, potentially diversifying supply sources.
Quality and Compliance Standards
Suppliers for MITIGO must adhere to stringent quality management systems, including:
- Good Manufacturing Practice (GMP) Compliance
- ISO Certifications
- Regulatory approvals and audits by agencies like the FDA, EMA, and equivalent authorities in target markets.
Consistency in quality is crucial given the biosimilar's complexity and the sensitivity of biologic drugs.
Key Considerations for Stakeholders
- Supply Chain Security: Given biologics' complexity, multiple tiered suppliers mitigate risks of shortages.
- Regulatory Alignment: Suppliers with proven compliance facilitate faster approval processes.
- Cost Implications: Contract manufacturing costs influence the overall pricing and accessibility of MITIGO.
- Regional Availability: Local suppliers become vital in reducing lead times and ensuring stable supply.
Key Takeaways
- The supply chain of MITIGO involves a layered network of contract manufacturers, fillers, and distributors across global regions.
- Major suppliers include WuXi Biologics, Samsung Biologics, and other CMOs with GMP-certified facilities.
- Licensing agreements frame regional manufacturing rights, influencing availability and pricing.
- Ensuring supplier compliance with regulatory standards is essential for maintaining product integrity and market access.
- Emerging suppliers and partnerships are likely to diversify and stabilize the supply landscape, especially amid global biosimilar market growth.
FAQs
1. Who are the primary contract manufacturers for MITIGO?
Major players include WuXi Biologics and Samsung Biologics, both capable of large-scale biosimilar production in compliance with global standards.
2. How does geographic regulation impact supplier choices for MITIGO?
Regulatory frameworks like the FDA and EMA influence where manufacturing occurs, as suppliers must meet specific regional compliance to enable product approval and distribution.
3. Are there alternative suppliers in emerging markets?
Yes, companies such as Sino Biologic and local CMOs in India and China are expanding their biosimilar manufacturing capabilities, potentially becoming regional suppliers for MITIGO.
4. What ensures the quality of MITIGO’s supply chain?
Suppliers adhere to GMP standards, ISO certifications, and undergo rigorous regulatory audits to ensure consistent quality and safety.
5. How might supply chain disruptions affect MITIGO availability?
Disruptions at any tier—manufacturing, logistics, or regulatory approval—can impact supply. Diversification of suppliers and regional manufacturing reduces such risks.
References
- [1] FDA Biosimilar Approval Process. U.S. Food and Drug Administration.
- [2] EMA Biosimilar Guidelines. European Medicines Agency.
- [3] WuXi Biologics: Capabilities and Certifications. WuXi Biologics Official Site.
- [4] Samsung Biologics: Manufacturing Services. Samsung Biologics Annual Report.
- [5] Market Dynamics in Biosimilars. IQVIA Institute Report, 2022.
More… ↓
