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Suppliers and packagers for MOZOBIL
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MOZOBIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311 | NDA | Sanofi-Aventis U.S. LLC | 0024-5862-01 | 1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE | 2013-09-01 |
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311 | NDA AUTHORIZED GENERIC | Fresenius Kabi Usa, LLC | 65219-284-12 | 1 VIAL, SINGLE-USE in 1 CARTON (65219-284-12) / 1.2 mL in 1 VIAL, SINGLE-USE | 2023-06-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MOZOBIL
Introduction
MOZOBIL, the brand name for sildenafil citrate, is a medication primarily used to treat erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). As a widely prescribed pharmaceutical, the supply chain for MOZOBIL involves a network of manufacturers, distributors, and regulatory agencies ensuring quality, availability, and compliance. This article elucidates the key suppliers involved in the production and distribution of MOZOBIL, highlighting the manufacturing landscape, regulatory considerations, and market dynamics influencing its supply chain.
Manufacturers of MOZOBIL
Pfizer Inc.: The Original Developer
Pfizer Inc. pioneered the development of sildenafil citrate, commercializing MOZOBIL in 1998. As the original patent holder and manufacturer, Pfizer maintained extensive production facilities worldwide, ensuring supply for global markets. The company's manufacturing plants are located primarily in:
- North America: Pfizer's U.S. facilities in Puerto Rico and elsewhere.
- Europe: Manufacturing sites across the European Union.
- Asia-Pacific: Facilities in India and China to meet regional demand.
Pfizer's tight control over intellectual property and quality standards historically positioned it as the primary supplier. However, patent expirations have since shifted supply dynamics.
Patent Expiry and Market Entry of Generics
The expiration of Pfizer's sildenafil patent around 2013-2018 significantly expanded the supplier base. Generic manufacturers worldwide now produce MOZOBIL or equivalent sildenafil citrate products, subject to regulatory approvals. Key generic suppliers include:
- Hetero Labs (India): One of the leading manufacturers of sildenafil citrate, supplying both the domestic Indian market and exports to numerous countries.
- Cipla (India): A major producer with extensive distribution networks, Cipla manufactures sildenafil for multiple formulations.
- Lupin Limited (India): Offers generic sildenafil as part of its portfolio, supplying numerous markets.
- R&D-based companies in China: Several Chinese pharmaceutical companies have entered the sildenafil market, offering competitively priced products.
These generics are often produced in compliance with strict Good Manufacturing Practice (GMP) standards, with many obtained WHO prequalification or FDA approval for international markets.
Distribution Channels and Suppliers
Authorized Distributors and Wholesalers
Post-manufacture, MOZOBIL supplies reach various distribution channels:
- Pharmacies and Retail Chains: Large retail pharmacy chains in Europe, the U.S., and Asia distribute both branded and generic sildenafil products.
- Hospital Pharmacies: Hospitals procure MOZOBIL through licensed distributors, often via tender processes.
- Online Pharmacies: Increasingly, online platforms source sildenafil, with suppliers ranging from licensed entities to unregulated vendors. Such channels highlight the importance of verifying supplier authenticity to avoid counterfeit products.
Regional Supply Dynamics
In emerging markets, local pharmaceutical companies or regional distributors often subcontract manufacturing or supply local versions, which may diverge from global standards but increase access.
- India and China: Dominant roles in local manufacturing and as export hubs.
- European Union: Stricter regulatory oversight mandates licensed suppliers and GMP compliance.
- United States: Only FDA-approved suppliers and distributors operate within the regulated market.
Regulatory and Quality Considerations
The supply of MOZOBIL hinges on rigorous compliance with global standards:
- FDA (U.S. Food and Drug Administration): Approves manufacturing facilities for sildenafil formulations, with strict inspection and monitoring.
- EMA (European Medicines Agency): Oversees approval and manufacturing certification in the EU.
- WHO Prequalification: Recognizes high-quality generic sildenafil products for procurement by international agencies and NGOs.
- National Regulatory Authorities: India’s CDSCO, China's CFDA, among others, govern local manufacturing approvals.
Non-compliance or counterfeit production poses risks to supply stability, emphasizing reliance on verified suppliers.
Supply Chain Challenges and Market Trends
Patent Expiration Impact
Patent expiry democratized supply but introduced market fragmentation, leading to increased competition among generics, fostering innovation in formulations (e.g., orodispersible tablets) and price reduction.
Supply Disruptions
Issues such as raw material shortages, manufacturing disruptions, or regulatory non-compliance can impact supply continuity. The recent global logistics challenges due to the COVID-19 pandemic further strained supply chains.
Emerging Markets
Rising prevalence of ED and PAH in developing economies promotes increased demand, incentivizing regional manufacturing and supply chain development.
Regulatory Harmonization
Global harmonization facilitates smoother cross-border supply. Companies investing in GMP compliance and regulatory approvals maintain resilient supply channels, especially in regulated markets like North America and Europe.
Conclusion
The supply landscape for MOZOBIL is highly segmental, with Pfizer historically at the forefront as the original manufacturer. Today, the global generic market—led by Indian pharmaceutical giants—dominates manufacturing, supported by regional distributors and regulatory frameworks to ensure quality. While patent expiry has increased competition, it has also necessitated rigorous quality controls to prevent counterfeit risks and maintain supply integrity. Ongoing market dynamics, regulatory developments, and geopolitical factors will shape the future of MOZOBIL’s supply chain.
Key Takeaways
- Pfizer was the original exclusive manufacturer of MOZOBIL; post-patent expiry, numerous generic companies, predominantly in India and China, now supply globally.
- Ensuring supply stability requires reliance on licensed, GMP-compliant suppliers, especially given the risks of counterfeit products and regulatory non-compliance.
- Distribution channels span retail, hospital, and online pharmacies, each with unique sourcing and regulatory considerations.
- Regulatory approvals from entities like FDA, EMA, and WHO are critical to maintaining supply integrity in global markets.
- Market growth in emerging economies presents opportunities for regional manufacturing and expanding access, though supply chain resilience remains crucial.
Frequently Asked Questions
1. Who are the primary manufacturers of MOZOBIL today?
While Pfizer initially developed and manufactured MOZOBIL, the current market is dominated by generic producers such as Hetero Labs, Cipla, Lupin, and Chinese pharmaceutical companies, all producing sildenafil citrate under various brand names and formulations.
2. How does patent expiry affect the supply of MOZOBIL?
Patent expiry allows multiple manufacturers globally to produce generic sildenafil citrate, increasing supply options, reducing prices, and expanding access, but also requiring stringent quality oversight to mitigate counterfeit risks.
3. What are the regulatory requirements for suppliers of MOZOBIL?
Manufacturers and distributors must comply with GMP standards and obtain approval from relevant authorities such as the FDA, EMA, or WHO prequalification to ensure product safety, efficacy, and quality.
4. How can consumers ensure they receive genuine MOZOBIL?
Consumers should purchase from licensed pharmacies, verify supplier credentials, and look for approved product markings. Online purchases should be made through reputable, regulated platforms to avoid counterfeit products.
5. What factors influence the supply chain stability of MOZOBIL?
Key factors include raw material availability, manufacturing capacity, regulatory compliance, geopolitical stability, logistics and transportation, and market demand fluctuations.
Sources:
- Pfizer Official Website. Sildenafil Citrate Information. https://www.pfizer.com.
- World Health Organization. WHO Prequalification of Medicines Programme. https://www.who.int.
- Indian Pharmaceutical Industry Reports. Department of Pharmaceuticals, India.
- U.S. FDA Drug Approvals Database. https://www.fda.gov.
- European Medicines Agency. Pharmacovigilance and approvals data. https://www.ema.europa.eu.
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