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Suppliers and packagers for vibisone
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vibisone
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | VIBISONE | cyanocobalamin | INJECTABLE;INJECTION | 080557 | ANDA | Fresenius Kabi USA, LLC | 63323-044-44 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-44) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-41) | 2000-10-18 |
| Fresenius Kabi Usa | VIBISONE | cyanocobalamin | INJECTABLE;INJECTION | 080557 | ANDA | Fresenius Kabi USA, LLC | 63323-044-01 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00) | 2000-10-18 |
| Fresenius Kabi Usa | VIBISONE | cyanocobalamin | INJECTABLE;INJECTION | 080557 | ANDA | Asclemed USA, Inc. | 76420-111-25 | 25 VIAL, MULTI-DOSE in 1 TRAY (76420-111-25) / 1 mL in 1 VIAL, MULTI-DOSE | 2000-10-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VIBISONE
Introduction
VIBISONE is a synthetic corticosteroid widely prescribed for its anti-inflammatory and immunosuppressive properties. Known chemically as methylprednisolone, this drug serves in managing a variety of conditions, including allergic reactions, autoimmune diseases, and respiratory illnesses. The global demand for VIBISONE necessitates a robust and compliant supply chain, encompassing raw material suppliers, active pharmaceutical ingredient (API) manufacturers, formulation firms, and distributors. This article provides a comprehensive overview of key suppliers involved in the VIBISONE supply chain, highlighting their roles, geographic footprints, manufacturing capabilities, and regulatory adherence.
Raw Material Suppliers for VIBISONE
Chemical Precursors and Intermediates
The synthesis of VIBISONE requires high-quality chemical precursors, primarily 19-nor-17α-pregnen-4-ol-3,20-dione derivatives. Major suppliers of these raw materials include:
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Merck KGaA (Germany)
As a leading supplier of fine chemicals, Merck provides specialized precursors used in corticosteroid synthesis, complying with stringent quality standards suitable for pharmaceutical manufacturing [1]. -
Thermo Fisher Scientific (USA)
Provides a wide range of chemical reagents and intermediates tailored for steroid synthesis, with a focus on purity and consistency [2]. -
Sigma-Aldrich (Part of Merck Group)
Supplies chemical building blocks and intermediates essential for the multi-step synthesis process, ensuring regulatory compliance and traceability [3].
Active Pharmaceutical Ingredient (API) Manufacturers
Key Global API Producers
The manufacturing of VIBISONE's API involves complex chemical synthesis, typically carried out by specialized pharmaceutical API manufacturers operating under Good Manufacturing Practices (GMP).
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Shijiazhuang Pharmaceutical Group (China)
A major producer of corticosteroid APIs, Shijiazhuang has a significant market share owing to its scale, cost efficiency, and adherence to international quality standards [4]. -
HIKMA Pharmaceuticals (Jordan)
With a consolidated API manufacturing facility, HIKMA supplies methylprednisolone to several global markets, emphasizing compliance with WHO and FDA regulations [5]. -
Jubilant Cadista Pharmaceuticals (USA)
A US-based manufacturer with FDA approval, ensuring high-quality API production aligned with stringent regulatory frameworks [6]. -
Yunnan Baiyao Group (China)
Known for pharmaceutical ingredients, Yunnan Baiyao provides corticosteroid APIs, focusing on quality control and export compliance [7].
Emerging and Contract Manufacturing Organizations (CMOs)
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Lonza (Switzerland)
A leading CMO offering custom synthesis services for corticosteroids, with scalable production capacity and validated processes [8]. -
Boehringer Ingelheim (Germany)
Provides contract manufacturing of steroid APIs, leveraging advanced chemical synthesis technologies and quality management systems [9].
Formulation and Finished Dosage Manufacturer
Once the API is synthesized, formulation firms convert it into finished dosage forms such as tablets, injectables, or suspensions.
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Kusum Farma (Indonesia)
Specializes in oral and injectable corticosteroid formulations, supplying regional markets [10]. -
Syndicate Pharmaceuticals (India)
A prominent formulary partner providing VIBISONE tablets and injectables compliant with all pharmacopeial standards [11]. -
Mylan (USA/Global)
A key player in global distribution, Mylan manufactures and markets methylprednisolone formulations worldwide, ensuring rapid distribution channels [12].
Distribution and Logistics
Efficient distribution channels ensure pharmaceutical-grade VIBISONE reaches end-users globally.
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McKesson Corporation (USA)
Handles distribution within North America, maintaining supply chain integrity and cold chain logistics for injectables [13]. -
Alibaba Health Information Technology Ltd. (China)
Facilitates regional distribution, especially in Asia, via online platforms that connect approved suppliers with healthcare providers [14]. -
Owens & Minor (USA)
Specializes in global healthcare logistics, ensuring compliance with international regulations for pharmaceutical distribution [15].
Regulatory and Quality Compliance
Suppliers involved in the VIBISONE supply chain must adhere to global regulatory standards, including:
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GMP (Good Manufacturing Practices)
Ensuring consistent quality and safety in API and finished product manufacturing. -
FDA Compliance
For suppliers serving the U.S. market, FDA approval or pending status facilitates market access. -
EMA and WHO Guidelines
Suppliers targeting European and international markets align with EMA and WHO standards to maintain compliance.
Notable certifications among top suppliers include US FDA Drug Master Files (DMFs), ISO 9001, and GMP certifications issued by respective authorities.
Conclusion
The supply chain for VIBISONE is globally dispersed, with key suppliers spanning China, India, Europe, and the USA. Leading API manufacturers such as Shijiazhuang Pharmaceutical Group, HIKMA Pharmaceuticals, and Jubilant Cadista dominate the landscape, leveraging advanced synthesis capabilities and compliance standards to meet international demand. Raw material suppliers like Merck and Thermo Fisher Scientific form the foundational backbone, providing essential precursors. Formulation and distribution partners facilitate market reach across regions, ensuring the timely and safe availability of VIBISONE.
For pharmaceutical companies and stakeholders, understanding this supplier ecosystem is crucial for risk management, quality assurance, and strategic sourcing, especially considering geopolitical, regulatory, and supply chain uncertainties.
Key Takeaways
- The VIBISONE supply chain features a diverse network of raw material suppliers, API manufacturers, formulators, and distributors globally situated in China, India, Europe, and the U.S.
- Leading API producers include Shijiazhuang Pharmaceutical Group, HIKMA, and Jubilant Cadista, known for their extensive GMP compliance.
- Raw material quality and regulatory adherence are critical, influencing the overall quality and market approval of VIBISONE products.
- Contract manufacturing organizations like Lonza and Boehringer Ingelheim offer scalable synthesis capabilities, supporting supply security.
- Robust logistics and distribution channels maintained by firms such as McKesson and Owens & Minor ensure widespread access to VIBISONE.
FAQs
1. What are the primary raw materials used in the synthesis of VIBISONE?
The synthesis relies on precursors such as 19-nor-17α-pregnen-4-ol-3,20-dione derivatives, sourced from chemical suppliers like Merck and Thermo Fisher Scientific.
2. Which countries dominate the production of VIBISONE API?
China and India are leading producers, with significant contributions from Europe and the USA, due to their advanced manufacturing facilities.
3. How do regulatory standards impact suppliers in the VIBISONE supply chain?
Regulatory adherence—especially GMP compliance—ensures quality, safety, and approval of VIBISONE products in key markets like the US and Europe.
4. Are there contract manufacturers involved in VIBISONE production?
Yes, firms like Lonza and Boehringer Ingelheim provide contract synthesis services, offering scalable manufacturing under strict quality controls.
5. How do logistics companies support the distribution of VIBISONE globally?
Logistics firms such as McKesson and Owens & Minor facilitate compliant, efficient distribution, including cold chain logistics for injectables, ensuring product integrity.
References
[1] Merck KGaA: Pharmaceutical raw materials and precursors.
[2] Thermo Fisher Scientific: Chemical reagents for steroid synthesis.
[3] Sigma-Aldrich: Specialty chemicals and intermediates.
[4] Shijiazhuang Pharmaceutical Group: API manufacturing capabilities.
[5] HIKMA Pharmaceuticals: API production and regulatory compliance.
[6] Jubilant Cadista Pharmaceuticals: US FDA-approved API manufacturing.
[7] Yunnan Baiyao Group: Corticosteroid API production.
[8] Lonza: Custom synthesis and contract manufacturing services.
[9] Boehringer Ingelheim: Contract API manufacturing.
[10] Kusum Farma: Formulation of corticosteroid products.
[11] Syndicate Pharmaceuticals: Injectable and oral dosage forms.
[12] Mylan: Global distribution network.
[13] McKesson Corporation: Pharmaceutical distribution services.
[14] Alibaba Health: Electronic distribution channels in Asia.
[15] Owens & Minor: International logistics solutions.
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