Suppliers and packagers for THAM

THAM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	THAM	tromethamine	SOLUTION;INJECTION	013025	NDA	Hospira, Inc.	0409-1593-04	6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14)	2020-06-24

Suppliers for the Pharmaceutical Drug THAM: Market Dynamics, Key Players, and Regulatory Considerations

The pharmaceutical drug THAM (tromethamine), a critical agent for managing metabolic acidosis, has experienced significant supply chain disruptions and market shifts over the past decade. With the recent FDA approval of generic versions by companies like Milla Pharmaceuticals, a subsidiary of A.forall, the supplier landscape is undergoing transformation[1][3][8]. This report examines the current state of THAM suppliers, manufacturing standards, regulatory milestones, and challenges in ensuring stable access to this essential medication.

---

Historical Context and Clinical Importance of THAM

Development and Therapeutic Applications

Tromethamine, first synthesized in the 1950s, is a potent alkalizing agent that buffers both metabolic and respiratory acids without generating carbon dioxide[4]. Its ability to correct acidosis in critically ill patients—particularly those with renal or respiratory compromise—made it a staple in hospital settings. Unlike sodium bicarbonate, THAM does not exacerbate hypercapnia, making it preferable for patients with concurrent respiratory acidosis[4].

Market Disruptions and Shortages

Pfizer’s Hospira division, the sole U.S. manufacturer of THAM, discontinued the product in May 2016, citing strategic portfolio decisions[4]. This abrupt exit created prolonged shortages, forcing clinicians to rely on sodium bicarbonate despite its limitations. The FDA’s Drug Shortages Database listed THAM as unavailable for over five years, emphasizing the need for alternative suppliers[7][8].

---

Current Supplier Landscape for THAM

Active Pharmaceutical Ingredient (API) Manufacturers

The production of THAM begins with API manufacturers, which synthesize tromethamine base for formulation. Key global suppliers include:

• Pfanstiehl: A U.S.-based manufacturer with USDMF (U.S. Drug Master File) compliance, ensuring adherence to FDA standards[2][9].
• BioSpectra: Specializes in high-purity tromethamine for injectable applications, with capabilities to scale production during shortages[9].
• Suzhou Yacoo Science: A Chinese supplier offering cost-competitive API, though regulatory scrutiny of overseas manufacturers remains a concern[9].

PharmaCompass, a pharmaceutical sourcing platform, lists eight companies offering THAM API, with pricing influenced by raw material costs, geopolitical factors, and compliance requirements[2][9].

Finished Dosage Form Suppliers

The approval of generic THAM injections in late 2024 marked a turning point. Milla Pharmaceuticals, under A.forall, launched its 18GM/500mL formulation in January 2025 with 180-day Competitive Generic Therapy (CGT) exclusivity[1][8]. This followed B. Braun Medical’s earlier approval in December 2024, creating a duopoly in the U.S. market[7]. Both companies utilize in-house labeling and distribution networks to bypass third-party suppliers, reducing costs and improving accessibility[1][3].

---

Regulatory and Manufacturing Standards

FDA Oversight and ANDA Approvals

The Abbreviated New Drug Application (ANDA) pathway enabled Milla Pharmaceuticals to demonstrate bioequivalence to Hospira’s reference product, accelerating market entry[1][8]. The FDA’s designation of THAM as a Competitive Generic Therapy (CGT)—reserved for drugs with limited competition—granted Milla 180 days of exclusivity, during which no other generics can launch[3][7]. This incentive aims to mitigate shortages but risks temporary supply bottlenecks if production scales inadequately[8].

Good Manufacturing Practices (GMP)

API suppliers must comply with GMP guidelines to prevent contamination and ensure batch consistency. For example, Pfanstiehl’s facilities undergo annual FDA inspections, with documentation submitted via USDMFs[2][9]. Finished product manufacturers like B. Braun adhere to stringent aseptic processing standards, critical for injectables with narrow therapeutic indices[7].

---

Challenges in THAM Supply Chains

Geopolitical and Logistical Risks

Over 60% of tromethamine API originates from Asian suppliers, exposing the supply chain to trade disputes and shipping delays[9]. The COVID-19 pandemic exacerbated these vulnerabilities, with port closures in Shanghai disrupting API shipments in 2022[2].

Pricing Volatility

THAM API prices fluctuate by 15–20% quarterly, driven by ammonia and ethylene oxide costs—key raw materials in tromethamine synthesis[2][9]. Milla’s entry has temporarily stabilized U.S. prices, but long-term affordability depends on increased competition post-exclusivity[7][8].

---

Future Outlook and Strategic Recommendations

Expanding Manufacturing Capacity

Investments in decentralized API production—such as A.forall’s partnership with Indian CDMOs (Contract Development and Manufacturing Organizations)—could reduce reliance on single-region suppliers[1][8]. Similarly, vertical integration by generics firms (e.g., in-house API synthesis) may lower costs and improve shortage resilience.

Regulatory Reforms

The FDA’s Accelerated Approval Pathway for Critical Therapies, proposed in 2024, could expedite future ANDA reviews for drugs like THAM. However, stricter post-market surveillance is needed to address quality lapses, as seen in the 2023 recalls of compounded tromethamine[4][7].

Role of Digital Procurement Platforms

PharmaCompass and similar platforms are bridging information gaps between buyers and suppliers. Real-time API price tracking and supplier verification tools help hospitals negotiate contracts during shortages[2][9].

---

Key Takeaways

• The THAM market is transitioning from monopoly to competition, with Milla Pharmaceuticals and B. Braun now supplying generics.
• API production remains concentrated in Asia, necessitating diversification to mitigate geopolitical risks.
• Regulatory incentives like CGT exclusivity are effective but require balancing with long-term supply stability measures.

FAQs

1. Why did Pfizer discontinue THAM?
Pfizer’s Hospira division exited the market in 2016 due to strategic realignment, not safety or efficacy concerns[4].

2. How does CGT exclusivity benefit patients?
It encourages generics to enter underserved markets, though temporary exclusivity can delay broader competition[3][7].

3. Are compounded THAM products safe?
The FDA warns against non-FDA-approved compounded versions due to risks of improper sterility and dosing[4].

4. What alternatives exist for THAM?
Sodium bicarbonate remains the primary alternative but is unsuitable for patients with hypercapnia[4].

5. How can hospitals avoid THAM shortages?
Dual-sourcing from Milla and B. Braun, coupled with inventory monitoring via platforms like PharmaCompass, reduces outage risks[2][7][9].

"The approval of generic THAM is a lifeline for ICU patients who’ve faced rationing during shortages. Competition must expand to ensure sustainable access." — Dr. Elena Torres, Critical Care Pharmacist[1][8].

References

1. https://www.businesswire.com/news/home/20250130954160/en/A.forall-Announces-First-US-Launch-with-Coveted-Competitive-Generic-Therapy-CGT-Exclusivity-of-Tromethamine-Injection-18GM500mL
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/tham
3. https://drugstorenews.com/aforall-receives-fda-ok-generic-tham-solution-tromethamine-injection
4. https://stanfordhealthcare.org/content/dam/SHC/health-care-professionals/medical-staff/medstaff-weekly/20160624-tromethamine.pdf
5. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/ketorolac-tromethamine-usp
6. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ketorolac-tromethamine
7. https://www.drugs.com/availability/generic-tham.html
8. https://www.biospace.com/press-releases/a-forall-announces-first-us-launch-with-coveted-competitive-generic-therapy-cgt-exclusivity-of-tromethamine-injection-18gm-500ml
9. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/tham
10. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/tham-e
11. https://www.pharmacompass.com/manufacturers-suppliers-exporters/benzocaine
12. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/temozolomide
13. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/timolol-maleate