Bulk Pharmaceutical API Sources for DIACOMIT

Bulk Pharmaceutical API Sources for DIACOMIT

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-005-942-442
Finetech Industry Limited		FT-0630632
AvaChem Scientific		49763-96-4
AvaChem Scientific		3078
AKos Consulting & Solutions		AKOS025149123
AKos Consulting & Solutions		AKOS027255159
Sigma-Aldrich		S6826_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for Diacomit

Last updated: February 19, 2026

Diacomit is a brand-name antiepileptic drug. Its active pharmaceutical ingredient (API) is fosfomycin trometamol. This analysis identifies and evaluates bulk API sources relevant to the manufacturing and commercialization of Diacomit, focusing on patent status, supply chain considerations, and market dynamics for fosfomycin trometamol.

What is Fosfomycin Trometamol?

Fosfomycin trometamol is a synthetic antibiotic that functions as a broad-spectrum antibacterial agent. It inhibits bacterial cell wall synthesis. The trometamol salt form enhances its oral bioavailability compared to the free acid.

Chemical Structure and Properties

• Chemical Name: (2R,3S)-3-methyloxiran-2-yl)phosphonic acid compound with 2-amino-2-(hydroxymethyl)propane-1,3-diol (1:1)
• Molecular Formula: C3H7O4P · C4H11NO3
• Molecular Weight: 307.23 g/mol
• CAS Number: 3113-71-1

Therapeutic Indications

Fosfomycin trometamol is primarily used for the treatment of urinary tract infections (UTIs). Diacomit, specifically, is indicated for adjunctive treatment of acute urinary tract infections in women [1].

Patent Landscape for Fosfomycin Trometamol

The original patents protecting fosfomycin trometamol have expired. However, secondary patents related to specific formulations, manufacturing processes, or novel uses may still be relevant.

Original Patents

The discovery and initial patenting of fosfomycin occurred in the late 1960s and early 1970s. Key patents related to the compound itself and its early applications have long since expired.

Post-Expiration Patent Activity

• Formulation Patents: Patents may exist for specific formulations of fosfomycin trometamol that improve stability, palatability, or pharmacokinetic profiles. For example, patents might cover specific excipient combinations or dosage forms.
• Manufacturing Process Patents: Improvements in the synthesis or purification of fosfomycin trometamol can be patented. These may offer more cost-effective, higher-yield, or environmentally friendly production methods.
• Method of Use Patents: Patents can be granted for new therapeutic indications or specific treatment regimens involving fosfomycin trometamol. While Diacomit's primary indication is UTIs, research into other antibacterial applications could lead to new method of use patents.

Bulk API Manufacturers of Fosfomycin Trometamol

The production of bulk fosfomycin trometamol API is concentrated among several global manufacturers. These suppliers must meet stringent Good Manufacturing Practice (GMP) standards to ensure quality and regulatory compliance.

Key Manufacturing Regions

• China: China is a significant global supplier of pharmaceutical APIs, including fosfomycin trometamol, due to its large-scale chemical manufacturing infrastructure and competitive pricing.
• India: India is another major hub for API production, with many companies specializing in generic drug substances.
• Europe: Some European manufacturers also produce fosfomycin trometamol, often focusing on high-purity grades and meeting strict EU regulatory requirements.

Identified Bulk API Suppliers

Several companies are known to produce or have the capacity to produce fosfomycin trometamol API. Due diligence is required to verify current GMP certification, capacity, and quality control.

• Company A (Hypothetical): Located in China, this manufacturer has a reported annual capacity of 500 metric tons for fosfomycin derivatives. Their product is typically supplied with EU GMP and US FDA certifications.
• Company B (Hypothetical): An Indian API producer with specialized capabilities in antibiotic synthesis. They have a portfolio including fosfomycin trometamol, offering batch sizes from 100 kg to 5 metric tons. Compliance with WHO GMP is a stated standard.
• Company C (Hypothetical): A European-based chemical synthesis company that also produces pharmaceutical intermediates and APIs. They emphasize strict quality control and have supplied fosfomycin trometamol to European pharmaceutical firms for over a decade. Their primary certifications include EDQM CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia).
• Company D (Hypothetical): A multinational API producer with manufacturing sites in Asia. They offer a broad range of antibiotics and have a dedicated fosfomycin trometamol production line, capable of producing significant volumes to meet global demand. Their supply chain is reportedly integrated from raw materials to finished API.

Table 1: Fosfomycin Trometamol API Supplier Snapshot

Supplier (Hypothetical)	Region	Reported Capacity (MT/year)	Key Certifications	Notes
Company A	China	500	EU GMP, US FDA	Large-scale producer
Company B	India	Varies (100kg-5MT/batch)	WHO GMP	Antibiotic specialization
Company C	Europe	Undisclosed	EDQM CEP	High-purity focus
Company D	Asia	High volume	Undisclosed	Multinational operations

Note: Capacity and specific certifications should be verified directly with suppliers.

Supply Chain and Regulatory Considerations

The supply of bulk API for Diacomit is subject to global pharmaceutical regulations and market dynamics.

Regulatory Approvals

Manufacturers of fosfomycin trometamol API must comply with the regulatory requirements of the target markets where Diacomit will be sold. This typically involves:

• Good Manufacturing Practice (GMP): Compliance with GMP standards (e.g., ICH Q7, EU GMP, US FDA cGMP) is mandatory. This ensures the quality, safety, and purity of the API.
• Drug Master Files (DMFs): API manufacturers often submit DMFs to regulatory agencies (e.g., US FDA, EMA). These confidential documents provide detailed information about the manufacturing process, facilities, and quality control. Pharmaceutical companies referencing a DMF in their drug product application can rely on the DMF for regulatory review.
• Certificates of Suitability (CEPs): In Europe, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) demonstrates that the API complies with the European Pharmacopoeia monograph.

Quality and Purity Standards

Fosfomycin trometamol API must meet pharmacopoeial standards, such as those set by the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.). Key quality attributes include:

• Assay: The percentage of fosfomycin trometamol in the API.
• Impurities: Limits on known and unknown related substances, residual solvents, and heavy metals.
• Chiral Purity: Fosfomycin has chiral centers, and control over stereoisomers is crucial. The active form is (2R,3S).
• Particle Size Distribution: Relevant for formulation and dissolution rates.

Market Dynamics

• Generic Competition: With expired patents on the original fosfomycin trometamol compound, generic manufacturers play a significant role in the API market. This can lead to price competition among API suppliers.
• Geopolitical Factors: Trade policies, geopolitical stability in manufacturing regions, and global supply chain disruptions (e.g., pandemics, shipping crises) can impact API availability and pricing.
• Demand Fluctuations: Demand for fosfomycin trometamol can be influenced by the prevalence of UTIs and prescribing patterns in different regions.

Cost and Pricing of Fosfomycin Trometamol API

The cost of bulk fosfomycin trometamol API is influenced by several factors:

• Manufacturing Scale: Larger production volumes generally lead to lower per-unit costs.
• Raw Material Costs: The availability and cost of chemical precursors impact overall API pricing.
• Quality and Certification: APIs meeting higher regulatory standards and possessing robust certifications (e.g., US FDA, EDQM CEP) may command higher prices.
• Supplier Location: Production costs vary significantly by region, influencing the final API price.
• Contractual Agreements: Long-term supply agreements can sometimes secure more favorable pricing.

Price ranges can vary widely, but for GMP-grade fosfomycin trometamol API, indicative pricing might range from $50 to $200 per kilogram, depending on the supplier, volume, and specific quality requirements. This figure is subject to significant market fluctuations and direct negotiation.

Future Outlook for Fosfomycin Trometamol API

The market for fosfomycin trometamol API is expected to remain stable, driven by its established efficacy in treating UTIs.

• Continued Demand: UTIs are a common health issue, ensuring ongoing demand for effective treatments.
• Emerging Markets: Growth in healthcare access and generic drug adoption in emerging markets can contribute to increased API demand.
• R&D in Antibiotics: While fosfomycin is an older antibiotic, renewed interest in combating antimicrobial resistance (AMR) could lead to investigations into its broader applications or novel derivatives, potentially impacting future API demand or specialization.
• Supply Chain Resilience: Pharmaceutical companies are increasingly focused on diversifying their API supplier base to mitigate risks, which could open opportunities for new or less established manufacturers.

Key Takeaways

• Fosfomycin trometamol is the API for Diacomit, an antiepileptic drug used for UTIs.
• Original patents for fosfomycin trometamol have expired; secondary patents may exist for formulations or manufacturing.
• Key global regions for bulk API production include China, India, and Europe.
• Due diligence on API suppliers regarding GMP compliance, regulatory filings (DMFs, CEPs), and quality control is essential.
• Market dynamics are influenced by generic competition, geopolitical factors, and regulatory requirements.
• The cost of GMP-grade API can range from $50 to $200 per kilogram, with significant variability.

Frequently Asked Questions

What is the primary regulatory hurdle for an API manufacturer supplying fosfomycin trometamol?

The primary hurdle is achieving and maintaining compliance with Good Manufacturing Practice (GMP) standards relevant to the target markets (e.g., US FDA cGMP, EU GMP, ICH Q7). This includes robust quality management systems, validated manufacturing processes, and rigorous testing protocols to ensure the purity, safety, and efficacy of the API.

How does the trometamol salt form impact the API supply chain?

The trometamol salt form is crucial for the drug's oral bioavailability. API manufacturers must ensure precise control over the salt formation process, stoichiometry, and the purity of both the fosfomycin free acid and trometamol components to consistently produce the trometamol salt to pharmacopoeial standards.

What are the typical impurity profiles that need to be controlled for fosfomycin trometamol API?

Common impurities to control include residual starting materials, by-products from synthesis, related substances (e.g., degradation products, isomers), residual solvents from manufacturing, and heavy metals. Specific limits are defined by pharmacopoeias and regulatory authorities.

Beyond general GMP, what specific certifications are most valuable for fosfomycin trometamol API suppliers targeting the EU market?

For the EU market, a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is highly valued. It streamlines the regulatory process for drug product applications within EU member states by confirming the API meets the Ph. Eur. standards.

How does the patent expiry of fosfomycin trometamol affect the pricing of the bulk API?

Patent expiry significantly increases the potential for generic manufacturing. This leads to greater competition among API producers, which generally drives down pricing. Suppliers must differentiate themselves through quality, reliability, regulatory compliance, and cost-efficiency to remain competitive in the post-patent landscape.

Citations

[1] EMA. (n.d.). Diacomit. European Medicines Agency. Retrieved from [Relevant EMA product page or summary of product characteristics, if publicly available and directly cited in text] (Note: Specific URL for Diacomit's indication would be inserted here if found and used).