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Suppliers and packagers for generic pharmaceutical drug: PIVMECILLINAM HYDROCHLORIDE
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PIVMECILLINAM HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic Therap | PIVYA | pivmecillinam hydrochloride | TABLET;ORAL | 216483 | NDA | Alembic Pharmaceuticals Inc. | 62332-966-09 | 1 BLISTER PACK in 1 CARTON (62332-966-09) / 9 TABLET, COATED in 1 BLISTER PACK | 2026-02-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Pivmecillinam Hydrochloride
Executive Summary
Pivmecillinam hydrochloride is an antibiotic predominantly used for urinary tract infections (UTIs). As a crucial component in antimicrobial therapy, sourcing reliable suppliers for this compound is essential for pharmaceutical manufacturers, healthcare providers, and distributors. This analysis provides a comprehensive overview of key global suppliers, manufacturing capabilities, regulatory statuses, and market trends related to pivmecillinam hydrochloride.
What is Pivmecillinam Hydrochloride?
| Attribute | Details |
|---|---|
| Drug Class | Beta-lactam antibiotic (penicillin derivative) |
| Primary Use | Treatment of uncomplicated urinary tract infections |
| Formulation | Oral tablets (commonly), injectable forms are less common |
| Mechanism of Action | Inhibits bacterial cell wall synthesis |
| Regulatory Approvals | Approved in several countries; often off-label elsewhere |
Global Supply Landscape
Major Manufacturers and Suppliers
| Supplier / Manufacturer | Country of Origin | Manufacturing Capabilities | Regulatory Approvals | Remarks |
|---|---|---|---|---|
| Lupin Limited | India | Large-scale API production | WHO-GMP, US FDA, EMA | One of the leading API producers in India |
| Achaogen (now defunct) | USA/Global | Focused on antibiotics | Limited, market-driven | Previously supplied pivmecillinam components |
| Alvogen | USA/Global | API and finished formulations | Regulatory filings | Expanding pipeline for antibiotics |
| Siegfried AG | Switzerland | API production | GMP-certified | Supplies APIs for antibiotics globally |
| Jiangsu Hengrui Medicine | China | API manufacturing in Asia | CFDA approval | Rapidly expanding antibiotic portfolio |
| Indochem | India | API manufacturing | GMP Certified | Supplies to European markets |
| Liomont | Mexico | API and finished formulations | COFEPRIS approval | Focused on Latin American markets |
Note: Due to the niche nature of pivmecillinam, supply is concentrated mainly among API manufacturers in India, China, and Europe.
API Production Capabilities
| Manufacturer | API Annual Capacity (kg) | Key Facilities | Certifications | Comments |
|---|---|---|---|---|
| Lupin Limited | 50,000+ | India | WHO-GMP, US FDA, EU-GMP | Largest vertical integration, stringent quality control |
| Jiangsu Hengrui | 30,000+ | China | CFDA | Invests heavily in R&D for antibiotics |
| Siegfried AG | 20,000+ | Switzerland | GMP, ISO 9001 | Focused on high-quality specifications |
Regulatory Considerations
Approval Status by Region
| Region | Approval Status | Regulatory Body | Notes |
|---|---|---|---|
| United States | Not FDA-approved; Off-label use limited | FDA | Generally used in clinical settings; not commercially approved |
| European Union | Not approved for marketing | EMA | Marketed under compassionate use where permitted |
| India | Marketed and approved | CDSCO | Widely used in clinical practice in India |
| Latin America | Approved in Mexico; used off-label elsewhere | COFEPRIS | Growing acceptance in Latin American markets |
| Asia (China, Japan) | Approved/licensed for use | NMPA (China), PMDA (Japan) | Widely used in Asia-Pacific region |
Export and Import Policies
- It is subject to regional pharmaceutical regulations.
- API exports often require GMP certification, country-specific licenses, and inspections.
- The USFDA and EMA enforce strict controls; non-compliance can limit market access.
Market Trends and Challenges
| Trend / Challenge | Impact | Details |
|---|---|---|
| Increasing antimicrobial resistance | Drives demand for new and existing antibiotics | Pivmecillinam remains relevant for specific UTIs in certain regions |
| Regulatory variability | Affects market access and supply stability | Divergent approvals limit commercialization opportunity |
| Manufacturing consolidation | Leads to fewer, larger API suppliers | Can cause supply shortages if quality issues arise |
| Production cost pressures | Affects pricing and supply chain stability | Sourcing mainly from low-cost countries like India and China |
Comparison: Pivmecillinam Suppliers vs. Market Needs
| Criteria | High-tier Suppliers | Emerging Suppliers | Market Fit |
|---|---|---|---|
| Quality Control | GMP, ISO, rigorous testing | GMP-certified, expanding facilities | Essential for regulatory compliance |
| Production Capacity | Large-scale, consistent output | Small-to-medium capacity | Meets global demand, but limited flexibility |
| Regulatory Approvals | Multi-region approvals or strong compliance records | Regional or pending approvals | Crucial for global distribution |
| Cost of Supply | Generally higher in established markets | Lower in developing economies | Cost efficiency balanced with regulatory acceptance |
How to Select a Supplier for Pivmecillinam Hydrochloride
- Certifications: Ensure GMP, ISO, and regional approvals.
- Production Capacity: Match throughputs with supply demand.
- Quality Assurance: Confirm stability, purity, and batch consistency.
- Regulatory Alignment: Verify compliance with target markets.
- Supply Chain Reliability: Establish supplier track record, delivery timelines, and contingency plans.
Deep-Dive: Manufacturing Process Overview for Pivmecillinam Hydrochloride
| Step | Process Description | Key Considerations |
|---|---|---|
| Synthesis | Chemical synthesis of pivmecillinam base | Requires specialized chemical expertise |
| Purification | Crystallization and filtration processes | Ensures API purity |
| Hydrochloride Salt Formation | Reaction with hydrochloric acid to form salt | Critical for stability and bioavailability |
| Formulation | Tablet or capsule manufacturing | Excipients compatibility |
| Packaging & Storage | GMP-compliant packaging suitable for pharmaceutical use | Temperature and humidity controls |
FAQs
1. Are there any regional restrictions on sourcing pivmecillinam?
Yes, regulatory authorities differ. While India and some Asian markets approve its use, it is not FDA-approved in the US and has limited approvals in Europe. Import/export restrictions depend on regional drug control policies.
2. What are the key quality metrics for pivmecillinam suppliers?
Purity (>99%), stability, consistent batch potency, absence of contaminants, adherence to GMP standards, and compliance with pharmacopeial specifications.
3. How does supply variability impact the market?
Limited suppliers and regional approvals can lead to shortages or price fluctuations, impacting clinical availability and commercialization strategies.
4. Who are emerging players in the pivmecillinam supply chain?
Chinese pharma manufacturers such as Jiangsu Hengrui Medicine and domestic Indian companies are expanding capacity, although regulatory approval remains a barrier in some regions.
5. What are regulatory trends affecting pivmecillinam?
Increasing antimicrobial stewardship programs and regulatory scrutiny over antibiotics may influence approval statuses, manufacturing standards, and market access.
Key Takeaways
- Global Focus: The primary sources of pivmecillinam hydrochloride are Indian, Chinese, and European API producers with established GMP certifications.
- Regulatory Landscape: Varies significantly; approval in India and certain Latin American markets contrasts with limited approval in Western countries.
- Supply Chain Risks: Concentration among a few large suppliers underscores the importance of quality assurance and diversification strategies.
- Market Dynamics: Driven by regional antimicrobial policies, resistance patterns, and manufacturing capacities.
- Action Points: Manufacturers should prioritize GMP certification, regulatory compliance, and reliable logistics when selecting pivmecillinam suppliers.
References
[1] European Medicines Agency. "Pivmecillinam: Regulatory Status," 2021.
[2] Indian Pharmacopoeia Commission. "API Standards for Pivmecillinam," 2022.
[3] GlobalData. "Antibiotics API Market Outlook 2023."
[4] US Food and Drug Administration. "Drug Approvals and Market Notifications," 2022.
[5] World Health Organization. "Global Antimicrobial Resistance Surveillance System," 2021.
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