Share This Page
Suppliers and packagers for MACROBID
✉ Email this page to a colleague
MACROBID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Almatica | MACROBID | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 020064 | NDA | Major Pharmaceuticals | 0904-7137-61 | 100 BLISTER PACK in 1 CARTON (0904-7137-61) / 1 CAPSULE in 1 BLISTER PACK | 2011-05-25 |
| Almatica | MACROBID | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 020064 | NDA | Alvogen Inc. | 47781-303-01 | 100 CAPSULE in 1 BOTTLE (47781-303-01) | 2011-05-25 |
| Almatica | MACROBID | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 020064 | NDA | Northwind Pharmaceuticals, LLC | 51655-611-02 | 2 CAPSULE in 1 BOTTLE, DISPENSING (51655-611-02) | 2014-07-18 |
| Almatica | MACROBID | nitrofurantoin; nitrofurantoin, macrocrystalline | CAPSULE;ORAL | 020064 | NDA | Northwind Pharmaceuticals, LLC | 51655-611-20 | 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-611-20) | 2014-07-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MACROBID
Introduction
MACROBID, the brand name for nitrofurantoin, is a well-established antibiotic primarily used to treat urinary tract infections (UTIs). Given its widespread adoption and critical role in antimicrobial therapy, understanding its suppliers is vital for healthcare providers, pharmaceutical distributors, and policy makers. This article assesses the global supply landscape, identifying key manufacturers and their sourcing strategies, regulatory considerations, and emerging trends impacting MACROBID’s supply chain.
Overview of MACROBID (Nitrofurantoin)
Nitrofurantoin, marketed as MACROBID among other brand names, was first approved by the U.S. Food and Drug Administration (FDA) in 1953. Its principal mode of action involves inhibiting bacterial enzyme systems necessary for fermentation, making it effective against common uropathogens, including Escherichia coli. The drug’s formulary includes capsules and oral suspensions, with the capsule form being predominant.
Historically, the manufacturing of nitrofurantoin involves chemically synthesized processes with multiple pharmaceutical and generic manufacturers involved across various regions.
Major Suppliers and Manufacturers
1. Pfizer Inc.
Overview: Pfizer, a global pharmaceutical titan based in the United States, has historically supplied MACROBID under its brand name and participates in broader antimicrobial markets.
Manufacturing footprint: Pfizer's manufacturing facilities are certified by global and regional regulatory agencies, including the FDA and EMA, ensuring high-quality standards.
Supply implications: As a leading supplier, Pfizer's production capacity has shaped the availability of MACROBID in North America and select international markets. Their extensive distribution network ensures steady supply, although patent and exclusivity periods influence generic competition.
2. Hikma Pharmaceuticals
Overview: Hikma, a UK-based generic pharmaceutical manufacturer, has become a significant supplier of nitrofurantoin in multiple formulations, including capsules of varying dosages.
Manufacturing footprint: Hikma’s manufacturing facilities in Europe and the Middle East produce high-quality generics, with rigorous adherence to Good Manufacturing Practices (GMP).
Supply implications: Hikma’s strategic production has solidified its role as a key provider of MACROBID generics, especially in European and emerging markets.
3. Teva Pharmaceutical Industries
Overview: An Israeli multinational and one of the world's largest generic drug manufacturers, Teva produces nitrofurantoin among its wide portfolio.
Manufacturing footprint: Teva operates manufacturing sites across North America, Europe, and Asia, facilitating extensive supply.
Supply implications: As a primary supplier of generic nitrofurantoin, Teva's ability to meet global demand makes it a critical component in the MACROBID supply chain, especially in North America.
4. Par Pharmaceuticals (a subsidiary of Teva)
Overview: Specializes in generic pharmaceuticals, with manufacturing capabilities tailored for high-volume antibiotic production.
Supply implications: Ensures a stable supply of nitrofurantoin formulations to various markets, often providing cost-effective options.
5. Other Notable Manufacturers
-
Sagent Pharmaceuticals: Offers generic nitrofurantoin in the U.S., expanding access and potentially influencing market competition.
-
Aurobindo Pharma: Indian manufacturer producing nitrofurantoin generics, mainly serving Asian and African markets.
-
Sun Pharmaceutical Industries: With manufacturing facilities in India, Sun Pharma supplies generic nitrofurantoin more broadly, including developing regions.
Regulatory Landscape and its Effects on Supply
Manufacturers must navigate complex regulatory frameworks, including approvals from the FDA, EMA, and other national agencies. Regulatory hurdles can cause supply disruptions, especially when manufacturing sites undergo inspections or certification updates. The FDA’s drug shortage reports have occasionally highlighted shortages of nitrofurantoin, often attributable to manufacturing issues or supply disruptions at key facilities.
In recent years, manufacturing shortages have been reported in North America, prompting healthcare providers to seek alternative antibiotics and emphasizing the need for diversified supplier bases.
Emerging Trends and Their Impact on Suppliers
1. Generic Market Expansion
The growth of generic versions of MACROBID has diversified the supplier landscape, decreasing reliance on brand-name manufacturing and increasing market resilience. This trend has prompted established players to expand capacity and improve cost efficiencies.
2. Supply Chain Disruptions
Global events, such as the COVID-19 pandemic and geopolitical tensions, have impacted raw material supply chains, affecting manufacturing stability—particularly for Indian and Chinese suppliers specializing in active pharmaceutical ingredients (APIs).
3. API Production and Sourcing
Nitrofurantoin’s active pharmaceutical ingredient (API) is primarily produced in India and China. Key API suppliers include:
- Hovid (Malaysia)
- Hetero (India)
- LG Chem (South Korea)
The consolidation of API production in these regions raises concerns regarding supply chain resilience, quality control, and geopolitical risks.
4. Regulatory and Quality Standards
In response to global quality concerns, regulatory agencies are enforcing stricter standards on API sourcing and drug manufacturing. Suppliers capable of demonstrating compliance with Good Manufacturing Practices (GMP) and obtaining certifications like EMA’s Certification of Suitability (CEP) are better positioned.
Key Challenges in the MACROBID Supply Chain
- API Availability: As a critical component, API shortages can bottleneck final drug production.
- Regulatory Approvals: Delays in approvals or inspections can temporarily restrict supply.
- Market Dynamics: Price pressures and generic competition influence manufacturer investments in capacity.
- Global Disruptions: Pandemics, political unrest, and trade restrictions impede consistent production.
Strategic Implications for Stakeholders
Healthcare providers should maintain diversified sourcing strategies, including multiple suppliers across geographies. Regulatory compliance and quality assurance are paramount to mitigate risks associated with manufacturing disruptions. Policymakers must monitor supply chains to preempt shortages, especially considering the essential nature of MACROBID in antimicrobial stewardship.
Pharmaceutical companies should prioritize API sourcing reliability, invest in alternative production methods, and maintain flexible manufacturing networks to withstand future disruptions.
Conclusion
The supply landscape for MACROBID is characterized by a combination of large pharmaceutical companies such as Pfizer, Hikma, and Teva, alongside regional generic manufacturers spanning India, China, and other emerging markets. While global supply chain complexities pose ongoing challenges, diversification of sources, robust regulatory compliance, and strategic API sourcing are essential to ensure uninterrupted availability.
Key Takeaways
- Major Suppliers: Pfizer, Hikma, Teva, and regional manufacturers supply MACROBID, with a significant portion of APIs originating from India and China.
- Regulatory Impact: Compliance with GMP and inspections influence manufacturing continuity; shortages often stem from regulatory or quality issues.
- Market Trends: Growing generic competition increases supply resilience but also emphasizes the need for diversified APIs and manufacturing sites.
- Supply Risks: API shortages, global disruptions, and regulatory hurdles pose ongoing risks, necessitating proactive sourcing strategies.
- Future Outlook: Enhanced supply chain monitoring, increased API production capabilities, and adoption of quality standards are vital for sustainable MACROBID supply.
FAQs
1. Who are the leading global manufacturers of MACROBID?
Major manufacturers include Pfizer, Hikma Pharmaceuticals, and Teva. These companies produce both branded and generic formulations, with API sourcing primarily from India and China.
2. What regions dominate the supply of MACROBID?
North America and Europe are primary markets for branded MACROBID, while generic production is more widespread, including India, China, and the Middle East.
3. How do API supply issues affect MACROBID production?
Disruptions in API supply, especially from India and China, can cause manufacturing delays and shortages in finished drug products.
4. Are there any regulatory challenges impacting MACROBID availability?
Yes. Inspections, certifications, and compliance with GMP standards are critical. Regulatory actions or delays can lead to temporary shortages.
5. What trends could influence MACROBID supply in the future?
Increased demand for generics, tighter API sourcing regulations, rising manufacturing costs, and supply chain resilience initiatives will shape the future supply landscape.
Sources
[1] U.S. Food and Drug Administration (FDA). Drug shortages.
[2] European Medicines Agency (EMA). API Certification Reports.
[3] IQVIA. Global Pharmaceutical Market Data, 2022.
[4] Pfizer Annual Report, 2022.
[5] Hikma Pharmaceuticals Annual Report, 2022.
More… ↓
