Suppliers and packagers for RENACIDIN

RENACIDIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
United Guardian	RENACIDIN	citric acid; gluconolactone; magnesium carbonate	SOLUTION;IRRIGATION	019481	NDA	United-Guardian, Inc.	0327-0012-30	30 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLE	2016-02-01

Suppliers for the Pharmaceutical Drug: Renacidin

Last updated: August 2, 2025

Introduction

Renacidin, a historically prescribed urinary acidifier and stone disintegrator, has seen fluctuating availability due to manufacturing shifts and regulatory changes. Its active ingredients, ammonium acid phosphate and magnesium ammonium phosphate, are components of formulations aimed at managing urinary conditions such as struvite stones. Navigating the current supplier landscape for Renacidin is critical for healthcare providers, pharmacists, and procurement professionals seeking continuity of care.

Overview of Renacidin and Market Dynamics

Developed in the mid-20th century, Renacidin gained prominence as a bladder irrigant and stone-dissolving agent, especially in urological practices. However, its market presence has diminished owing to concerns surrounding its safety profile, regulatory scrutiny, and the advent of alternative therapies.

The original manufacturing by Johnson & Johnson under the drug name “Renacidin” has faced discontinuations at various points, leading to shortages and prompting compounding pharmacies to formulate similar preparations. As a result, the landscape today comprises few direct suppliers, with most options arising from compounding sources or potential generic manufacturers.

Current Major Suppliers and Manufacturing Sources

1. Original Manufacturers

While Johnson & Johnson historically produced Renacidin, its commercial availability in the United States and Europe has largely been phased out or strictly regulated. Existing formulations are often authorized through off-label compounded versions rather than commercially marketed products.

2. Generic and Compounded Suppliers

Due to the discontinuation of mass-market Renacidin, compounding pharmacies have become primary suppliers. These pharmacies prepare the drug on a per-prescription basis, sourcing raw materials directly from chemical suppliers. Some notable sources include:

• Chemical Suppliers of Active Ingredients:

  • Sigma-Aldrich (Merck Group): Provides ammonium acid phosphate and magnesium ammonium phosphate for compounding purposes[1].
  • Thermo Fisher Scientific: Offers pharmaceutical-grade chemicals suitable for compounding.

• Compounding Pharmacy Networks:

  • Several specialized compounding pharmacies in the US, such as Boca Raton-based Pharmedium or Lloyds Pharmacy, have been known to prepare Renacidin formulations, contingent upon regulatory compliance and physician prescriptions.

3. Potential for Commercial Generic Production

Few companies currently house the manufacturing capacity to produce Renacidin as a commercial, FDA-approved drug. However, generic firms interested in niche therapies sometimes pursue abbreviated approval pathways, including 505(b)(2) applications, to reintroduce formulations. Notable efforts include:

• Indigenous Generic Manufacturers:
  While none have explicitly announced plans for Renacidin, the trend suggests potential in specialized sterile injectable or solution markets.

• Contract Manufacturing Organizations (CMOs):
  Contract manufacturers may produce Renacidin on a small scale, primarily for approved compounding pharmacies, subject to GMP compliance and market demand.

4. Regulatory and Supply Chain Considerations

Strict regulatory oversight governs the supply chain, especially for compounded drugs. The FDA emphasizes quality and safety, requiring compounding pharmacies to source high-purity raw materials. Importantly, the Drug Supply Chain Security Act (DSCSA) enhances traceability of active pharmaceutical ingredients (APIs) which affects sourcing strategies.

Challenges and Risks

• Limited Commercial Availability: Few mainstream pharmaceutical companies produce Renacidin, leading to reliance on compounding or importation.
• Regulatory Scrutiny: Increased oversight on compounded drugs raises questions on safety, quality, and consistency.
• Supply Disruptions: Dependence on raw chemical suppliers can result in shortages if supply chains are disrupted.
• Market Scarcity: The minimal commercial market diminishes incentives for large-scale production, potentially leading to supply vulnerabilities.

Emerging and Alternative Suppliers

The evolving landscape explores alternative suppliers, including:

• Offshore API Suppliers: Countries like India and China are significant sources for pharmaceutical-grade chemicals, including ammonium acid phosphate. Stringent quality verification is essential to ensure compliance with Good Manufacturing Practices (GMP).

• Pharmaceutical Codevelopment: Some biotech firms may consider developing proprietary formulations or biosimilars, but none are widely reported for Renacidin.

Summary of Major Suppliers

Supplier Category	Key Players	Notes
Original branded manufacturer	Johnson & Johnson (discontinued)	Historically significant, no longer actively marketed
Chemical and API suppliers	Sigma-Aldrich, Thermo Fisher Scientific	Source raw ingredients for compounding
Compounding pharmacies	Multiple US-based pharmacies	Custom formulations per prescription
Contract manufacturing entities	Various, including specialized CMOs	Potential re-manufacturers for small-scale production
International API sources	Suppliers from India, China (verified GMP suppliers)	For raw materials, with rigorous quality checks

Implications for Stakeholders

Healthcare providers seeking access to Renacidin should verify the source, ensuring compliance with regulatory standards. Pharmacists must establish verified supply chains, emphasizing documentation and testing of raw materials. Companies interested in manufacturing should pursue approvals through appropriate regulatory pathways, considering the limited market size.

Key Takeaways

• The primary suppliers of Renacidin today are predominantly compounding pharmacies sourcing raw ingredients from chemical suppliers.
• The original marketed product by Johnson & Johnson is largely unavailable, prompting reliance on off-label compounding or importation of ingredients.
• Strict regulatory oversight and quality assurance are crucial in sourcing raw materials and preparing formulation.
• Potential exists for small-scale generic manufacturing via CMOs, especially if market demand increases or new regulatory pathways are established.
• Stakeholders must navigate complex supply chains, emphasizing safety, compliance, and traceability.

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FAQs

1. Is Renacidin available as an FDA-approved commercial product?
No. The original Renacidin formulation by Johnson & Johnson has been discontinued, and there are no current FDA-approved commercial products. It is primarily prepared through compounding.

2. How can I ensure the quality of raw materials for compounding Renacidin?
Source from verified chemical suppliers with GMP certification, and perform quality testing upon receipt. Establish supplier verification protocols aligned with regulatory standards.

3. Are there international suppliers that provide raw ingredients for Renacidin?
Yes. Suppliers from India and China provide pharmaceutical-grade ammonium acid phosphate and related chemicals. Due diligence and GMP compliance verification are essential before procurement.

4. Can pharmaceutical manufacturers reintroduce Renacidin commercially?
Potentially, but the process involves complex regulatory approval pathways, market analysis, and investment. No major manufacturers have announced plans for commercial Renacidin production recently.

5. What are alternatives if Renacidin is unavailable?
Physicians may consider alternative therapies for urinary stone management, or compounded formulations prepared by qualified pharmacies, ensuring safety and efficacy.

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References

[1] Sigma-Aldrich. Ammonium Acid Phosphate and Magnesium Ammonium Phosphate. Available at: https://www.sigmaaldrich.com/