Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

Vendor	Vendor Homepage	Vendor Sku	API Url
AAA Chemistry		AR-1J3191
Hangzhou APIChem Technology		AC-11712
IS Chemical Technology		I01-2012
IS Chemical Technology		I01-4416
MolPort		MolPort-003-666-319

Bulk Active Pharmaceutical Ingredient (API) Sources for Lidocaine Hydrochloride 0.4% in Dextrose 5%

Last updated: July 27, 2025

Lidocaine Hydrochloride 0.4% in Dextrose 5% is a sterile solution primarily used as a cardiac antiarrhythmic agent administered intravenously[3][6][12]. The formulation combines lidocaine hydrochloride, a local anesthetic and antiarrhythmic drug, with dextrose to maintain osmotic balance. Identifying bulk API sources for this product requires analyzing regulatory filings, manufacturing practices, and supplier networks.

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Regulatory Framework for API Sourcing

503B Outsourcing Facilities and Bulk Drug Substances

Under Section 503B of the Federal Food, Drug, and Cosmetic Act, outsourcing facilities may compound drugs using bulk APIs if the substance appears on the FDA’s 503B Bulks List[1]. Lidocaine hydrochloride was nominated for inclusion on this list by multiple entities, including Pentec Health and the Outsourcing Facilities Association, citing needs for preservative-free preparations, customized concentrations (0.25%–30%), and combination therapies[1]. The nomination emphasized that bulk APIs enable precise potency adjustments and reduce contamination risks compared to manipulating finished dosage forms[1][5].

Current Good Manufacturing Practices (CGMP)

Bulk API manufacturers must comply with CGMP standards to ensure purity, stability, and consistency. Unlike finished products, bulk lidocaine hydrochloride can be formulated to 100% potency, eliminating inherent variances seen in commercial formulations[1][5]. This precision is critical for compounding facilities producing tailored solutions like the 0.4% lidocaine in 5% dextrose combination.

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Key API Manufacturers and Suppliers

Cerata Pharmaceuticals

Cerata Pharmaceuticals, based in India, is a leading global supplier of lidocaine HCl API in IP/BP/USP/EP grades[5]. The company’s manufacturing facilities adhere to WHO-GMP, FDA, and DCGI standards, enabling exports to over 90 countries[5]. Cerata offers lidocaine HCl API in 25 kg HDPE drums, making it a primary source for compounding facilities and finished drug manufacturers[5].

PharmaCompass-Listed Suppliers

PharmaCompass aggregates data on 57 lidocaine hydrochloride API suppliers, including manufacturers, distributors, and exporters[2][4][10][11]. Notable entities include:

• Hospira (Pfizer): Produces the finished product (0.4% lidocaine HCl in 5% dextrose) under NDC 00264-9594[6][9][13]. While Hospira’s API sourcing strategy isn’t explicitly disclosed, its compliance with CGMP suggests reliance on audited bulk suppliers like Cerata.
• B. Braun Medical: Markets lidocaine HCl 0.4% in 5% dextrose in Excel IV containers, with specific gravity of 1.018 and pH 4.4[6][13]. B. Braun’s supply chain likely involves partnerships with API manufacturers listed on PharmaCompass.

Drug Master Files (DMFs)

Suppliers providing lidocaine HCl API for U.S. markets typically submit Drug Master Files (DMFs) to the FDA. For example:

• USDMF Holders: PharmaCompass lists USDMF submissions for lidocaine HCl 0.4% in dextrose 5%, though specific filers are redacted[8]. These filings confirm compliance with FDA’s CGMP and quality standards.
• Non-U.S. DMFs: Cerata Pharmaceuticals holds certifications for EU-WC, JDMF, and KDMF, facilitating international API distribution[5].

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API Pricing and Market Dynamics

The lidocaine hydrochloride API market is influenced by factors such as raw material costs, regulatory changes, and geopolitical conditions. On PharmaCompass, lidocaine HCl API prices range from $80–$150/kg, depending on order volume and supplier credentials[2][10]. Compounding facilities prioritize suppliers with ISO certifications and audit-ready documentation to mitigate regulatory risks[5][11].

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Compounding and Formulation Considerations

Sterile Processing Requirements

Lidocaine HCl 0.4% in dextrose 5% requires aseptic processing due to its intravenous use. Bulk APIs enable outsourcing facilities to use advanced robotic isolation systems, minimizing human intervention during compounding[1][5]. This is critical for meeting USP <797> and <800> standards for sterile preparations.

Excipient Compatibility

The dextrose component (5% w/v) serves as a stabilizer and osmotic agent. API suppliers must ensure lidocaine HCl’s compatibility with dextrose under varying pH (3.0–7.0) and temperature conditions[3][6][12]. Certificates of Analysis (CoA) from API manufacturers validate these parameters prior to formulation.

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Challenges in API Sourcing

Supply Chain Disruptions

The FDA’s Drug Shortages Database has noted intermittent shortages of lidocaine injections, driven by API supply bottlenecks[9]. Facilities using single-source API suppliers are particularly vulnerable, prompting many to diversify their vendor networks through platforms like PharmaCompass[2][10].

Regulatory Scrutiny

In 2024, the FDA issued warning letters to three Indian API manufacturers for data integrity violations, underscoring the importance of rigorous supplier audits[5]. Compounding pharmacies must verify their API suppliers’ CGMP compliance to avoid product recalls.

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Conclusion

Bulk API sources for lidocaine hydrochloride 0.4% in dextrose 5% include globally compliant manufacturers like Cerata Pharmaceuticals and suppliers listed on PharmaCompass. Regulatory requirements, sterile processing needs, and market dynamics shape the sourcing strategies of outsourcing facilities and finished drug manufacturers. Continuous monitoring of supplier compliance and supply chain resilience remains essential to ensuring consistent access to this critical antiarrhythmic agent.

References

1. https://archive.hshsl.umaryland.edu/server/api/core/bitstreams/cf555933-ee2d-4030-9302-6f6a151cbe30/content
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/lidocaine-hydrochloride-0-2-and-dextrose-5-in-plastic-container
3. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7dff29d9-522d-40eb-a9d9-42377912d640
4. https://www.pharmacompass.com/manufacturers-suppliers-exporters/lidocaine-hcl-0-4-in-dextrose-5-in-plastic-container
5. https://ceratapharma.com/product/lidocaine-hcl-base-api-45
6. https://www.bbraunusa.com/en/products/b0/0-4-lidocaine-hydrochlorideand5dextroseinjectionusp4mgml2g.html
7. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf
8. https://www.pharmacompass.com/us-drug-master-files-dmfs/lidocaine-hcl-0-4-in-dextrose-5-in-plastic-container
9. https://www.drugpatentwatch.com/p/fda-orange-book/supplements/orangebook-ed24-supp12-.pdf
10. https://www.pharmacompass.com/active-pharmaceutical-ingredients/xylocaine
11. https://www.pharmacompass.com/active-pharmaceutical-ingredients/lidocaine-hcl
12. https://www.drugs.com/pro/lidocaine-and-dextrose.html
13. https://www.bbraunusa.com/en/products/b0/0-4-lidocaine-hydrochlorideand5dextroseinjectionusp4mgml1g.html
14. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f21512ea-c7c3-4766-b976-b2c0b5616bf0