Suppliers and packagers for generic pharmaceutical drug: lidocaine

lidocaine

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	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Limited	46708-424-30	1 TUBE in 1 CARTON (46708-424-30) / 30 g in 1 TUBE	2025-02-11
Alembic	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Limited	46708-424-35	1 TUBE in 1 CARTON (46708-424-35) / 35.44 g in 1 TUBE	2025-02-11
Alembic	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Limited	46708-424-50	50 g in 1 JAR (46708-424-50)	2025-02-11
Alembic	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	211469	ANDA	Alembic Pharmaceuticals Inc.	62332-424-30	1 TUBE in 1 CARTON (62332-424-30) / 30 g in 1 TUBE	2018-11-30

Global Landscape of Lidocaine Suppliers in the Pharmaceutical Industry

The pharmaceutical drug lidocaine, a critical local anesthetic and antiarrhythmic agent, is supplied by a diverse network of manufacturers, distributors, and specialized formulators across the globe. As of 2025, the market is characterized by established multinational corporations, regional suppliers in Asia and North America, and niche players focusing on topical formulations or sterile injectables. Key manufacturers like LGM Pharma, Merck, and Sambria Pharmaceuticals dominate segments of the market through advanced manufacturing capabilities, regulatory compliance, and innovative product offerings. Regional hubs in China and India continue to expand their influence, offering competitive pricing and scalable production, while platforms like PharmaCompass and PipelinePharma streamline global supplier-buyer connections.

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Key Global Manufacturers and Market Leadership

LGM Pharma’s Dominance in API Sourcing

LGM Pharma emerges as the foremost supplier of lidocaine active pharmaceutical ingredients (APIs), commanding a 46% click share among manufacturers as of April 2025[1]. The company’s expertise spans API sourcing, formulation development, and commercialization support, positioning it as a full-service contract development and manufacturing organization (CDMO)[2]. Its global reach ensures lidocaine APIs meet stringent Good Manufacturing Practices (GMP), catering to pharmaceutical and biotech industries worldwide[2].

Merck, a longstanding leader in pharmaceuticals, holds the second position with a 16.4% market share, leveraging its extensive distribution networks and reputation for quality[1]. Uma Brothers, an Indian manufacturer established in 1978, ranks third (11.3%) and supplies lidocaine intermediates to markets in Oman, Vietnam, and Canada, backed by Indian FDA certifications[1].

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Regional Suppliers and Manufacturing Hubs

China’s Competitive Pricing and Scalability

Chinese manufacturers like Xi’an Tian Guangyuan Biotech Co., Ltd. and Shandong Chenghui Shuangda Pharmaceutical Co. Ltd. offer lidocaine APIs at prices ranging from $20 to $120 per kilogram, with minimum order quantities (MOQs) as low as 1 kg[11]. These companies emphasize scalability, with Shandong Chenghui operating six workshops and nine production lines capable of 100 tons monthly output[4]. Shenzhen Huangxian Technology and Guangzhou Shengyu Chemical further underscore China’s role as a cost-effective supplier, particularly for bulk API procurement[11].

India’s Growing Influence

India’s Tenatra Exports Private Limited and Gonane Pharma specialize in exporting lidocaine hydrochloride, combining regulatory compliance with competitive pricing[3][8]. Tenatra, family-owned since 2002, emphasizes long-term partnerships and seamless logistics, while Gonane Pharma adheres to ISO 9001:2015 standards for API exports[2][8]. AdvaCare Pharma, operating GMP-certified facilities in India, China, and the USA, distributes lidocaine HCl injections to over 65 countries, highlighting India’s dual role as a manufacturer and global distributor[13].

U.S.-Based Sterile Injectable Suppliers

In the U.S., Fagron Sterile Services and Afaxys Pharma supply FDA-approved lidocaine hydrochloride injections. Fagron’s 268,000-square-foot facilities support instant shipping of sterile vials, ensuring supply chain resilience for hospitals and clinics[12]. Afaxys collaborates with distributors like McKesson and Henry Schein, offering 20 mL multi-dose vials (NDC 50102-400-10) tailored for clinical settings[14].

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Specialized Suppliers and Formulations

Topical Lidocaine Cream Innovators

Sambria Pharmaceuticals stands out in the topical lidocaine segment, supplying single-use, sanitary packets under its NeuroMed brand[5][7]. Its proprietary formulation enhances skin penetration, achieving rapid onset and limited systemic absorption, with pricing competitive against bulk tube-based alternatives[5]. The company also offers private labeling services, managing regulatory filings and packaging design for distributors[7].

Sterile Injectable Manufacturers

AdvaCare Pharma and Olympia Pharmaceuticals focus on lidocaine HCl injections, emphasizing GMP compliance and global distribution. AdvaCare’s 1% and 2% concentrations are produced in facilities routinely inspected per WHO guidelines, catering to dermatological and dental procedures[13][15]. Olympia highlights dosage flexibility, offering intramuscular, intravenous, and subcutaneous administration routes[15].

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Regulatory Compliance and Quality Assurance

GMP and FDA Standards

Lidocaine API manufacturers must adhere to GMP guidelines, ensuring batch consistency and safety[2][8]. LGM Pharma and Merck exemplify compliance, with LGM’s APIs meeting USP, BP, and EP pharmacopeial standards[2]. In China, Xi’an Tian Guangyuan Biotech maintains strict quality control with 15 years of API production experience, while Shandong Chenghui holds four U.S. Drug Master Files (USDMFs) and five CEP certifications[4][11].

Regulatory Platforms

PharmaCompass and PipelinePharma simplify supplier verification by aggregating data on certifications (e.g., USDMF, CEP) and API prices. PharmaCompass lists 32 lidocaine suppliers and 57 lidocaine hydrochloride providers, enabling direct connections between buyers and manufacturers[2][8]. PipelinePharma’s pre-audited suppliers, including AstraZeneca and Teva, mitigate risks of counterfeit products, particularly for generic formulations[6][9].

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Pricing Trends and Market Dynamics

Cost Variability and Negotiation

Lidocaine API prices fluctuate based on purity, volume, and geopolitical factors. Chinese suppliers offer the lowest rates, with Xi’an Frazer Biotech pricing lidocaine at $30–48/kg, compared to LGM Pharma’s premium-tier pricing[11][2]. Sambria’s NeuroMed cream disrupts the topical market at $0.10–$100 per box, undercutting traditional multi-use tubes[5][7].

Supply Chain Resilience

Fagron Sterile Services and McKesson address logistics challenges through instant shipping programs and diversified portfolios. Fagron’s three U.S. facilities ensure 100% sterility testing, critical for hospitals requiring reliable anesthetic stocks[12][14].

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Emerging Trends and Future Outlook

Personalized Medicine and Niche Formulations

The rise of medical spas and aesthetic clinics drives demand for tailored lidocaine products. Sambria’s BLT Convenience Package, combining benzocaine, lidocaine, and tetracaine, exemplifies this trend, targeting dermatology and plastic surgery applications[7].

Asia’s Expanding Market Share

Chinese and Indian manufacturers are projected to capture 60% of the global lidocaine API market by 2030, driven by cost advantages and scalable infrastructure[11][3]. Investments in USDMF submissions and CEP certifications will further solidify their positions in regulated markets[4][8].

Sustainability and Green Chemistry

Future initiatives may focus on eco-friendly synthesis methods for lidocaine, reducing solvent waste and energy consumption. Suppliers like LGM Pharma and Tenatra are well-positioned to lead this transition, given their R&D capabilities[2][3].

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Conclusion

The lidocaine supply chain is a multifaceted ecosystem involving global API giants, regional manufacturers, and specialized formulators. Quality assurance, regulatory compliance, and competitive pricing remain pivotal, with platforms like PharmaCompass enhancing market transparency. As demand grows—particularly for sterile injectables and topical applications—suppliers must balance scalability with innovation, ensuring reliable access to this essential anesthetic.

References

1. https://us.metoree.com/categories/6552/
2. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/lidocaine
3. https://pharmaoffer.com/api-excipient-supplier/local-anesthetics/lidocaine
4. https://pharmaoffer.com/api-excipient-supplier/local-anesthetics/lidocaine-hydrochloride
5. https://sambriapharma.net/blog/wholesale-lidocaine-cream/
6. https://www.pipelinepharma.com/lidocaine-hydrochloride-manufacturers
7. https://sambriapharma.net/blog/lidocaine-cream-supplier/
8. https://www.pharmacompass.com/manufacturers-suppliers-exporters/lidocaine-hydrochloride
9. https://www.pipelinepharma.com/lidocaine-hydrochloride-manufacturers/country/spain/category/generics
10. https://www.pipelinepharma.com/lidocaine-hydrochloride-manufacturers/country/taiwan
11. https://www.made-in-china.com/products-search/hot-china-products/Lidocaine.html
12. https://www.fagronsterile.com/products/lidocaine-hcl-injection-pf-1-10mg-ml-100mg-10ml
13. https://www.advacarepharma.com/en/pharmaceuticals/lidocaine-hcl-injection
14. https://afaxyspharma.com/products/adjacent-products/lidocaine-hydrochloride-injection/
15. https://www.olympiapharmacy.com/product/lidocaine-hcl-1/