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Suppliers and packagers for generic pharmaceutical drug: epinephrine bitartrate; lidocaine hydrochloride
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epinephrine bitartrate; lidocaine hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Deproco | LIGNOSPAN FORTE | epinephrine bitartrate; lidocaine hydrochloride | INJECTABLE;INJECTION | 088389 | ANDA | Septodont, Inc. | 0362-0262-05 | 50 CARTRIDGE in 1 CARTON (0362-0262-05) / 1.7 mL in 1 CARTRIDGE | 2018-08-10 |
| Deproco | LIGNOSPAN FORTE | epinephrine bitartrate; lidocaine hydrochloride | INJECTABLE;INJECTION | 088389 | ANDA | Septodont, Inc. | 0362-1096-70 | 5 BLISTER PACK in 1 CARTON (0362-1096-70) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE | 2017-12-01 |
| Deproco | LIGNOSPAN FORTE | epinephrine bitartrate; lidocaine hydrochloride | INJECTABLE;INJECTION | 088389 | ANDA | Henry Schein Inc. | 0404-6500-15 | 50 CARTRIDGE in 1 CARTON (0404-6500-15) / 1.7 mL in 1 CARTRIDGE | 2011-11-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Global Pharmaceutical Suppliers of Epinephrine Bitartrate and Lidocaine Hydrochloride
The pharmaceutical compounds epinephrine bitartrate and lidocaine hydrochloride are critical components in various medical formulations, particularly in local anesthesia and emergency care. Epinephrine, a vasoconstrictor, prolongs the anesthetic effect of lidocaine by reducing systemic absorption, while lidocaine serves as a rapid-acting local anesthetic. This report analyzes the global supplier landscape for these active pharmaceutical ingredients (APIs) and their combined formulations, emphasizing regulatory compliance, manufacturing practices, and market dynamics.
Regulatory Frameworks Governing API Production
Good Manufacturing Practices (GMP) and Certification Requirements
Pharmaceutical suppliers of epinephrine bitartrate and lidocaine hydrochloride must adhere to stringent regulatory standards, including Good Manufacturing Practices (GMP)[1][2][3]. The U.S. Food and Drug Administration (FDA) mandates that manufacturers comply with Current GMP (cGMP) to ensure product safety, efficacy, and consistency[1][6]. For instance, Pfizer Inc., a leading supplier of combined lidocaine-epinephrine formulations, maintains FDA-approved facilities that undergo routine inspections to validate compliance with 21 CFR Part 211[4][6]. Similarly, the European Medicines Agency (EMA) requires manufacturers to hold Certificates of Suitability (CEP) for API production, ensuring alignment with the European Pharmacopoeia[1][3].
Regional Regulatory Variations
Suppliers operating in emerging markets, such as India and China, often navigate divergent regulatory landscapes. Indian manufacturers like Zesla Chemicals and Pharmaceuticals and JK Chemicals comply with the Indian Pharmacopoeia (IP) and USDMF filings for U.S. exports[7][10]. In contrast, Chinese suppliers like Shandong Chenghui Shuangda Pharmaceutical prioritize National Medical Products Administration (NMPA) standards while seeking WHO prequalification for global distribution[8][10]. These regional disparities necessitate rigorous due diligence when selecting suppliers for international procurement[1][7].
Global Supplier Landscape for Epinephrine Bitartrate
North American and European Suppliers
Henry Schein Inc., a U.S.-based distributor, markets Lidocaine Hydrochloride and Epinephrine Bitartrate Injection under NDC 0404-6512-05, manufactured in FDA-compliant facilities[6]. The product’s sterile isotonic formulation meets USP specifications for pH and particulate matter, ensuring compatibility with dental and surgical applications[6]. In Europe, Duchefa Farma B.V. (Netherlands) and Boehringer Ingelheim (Germany) supply epinephrine APIs with EMA-approved CEPs, emphasizing cold-chain logistics for temperature-sensitive batches[11].
Asian Manufacturers and Cost-Effective Sourcing
India’s Janus Biotech stands out as a leading adrenaline bitartrate injection supplier, offering third-party manufacturing services with WHO-GMP certification[9]. Their formulations, such as Adrenaline Bitartrate 1 mg Injection, cater to emergency care needs in low-resource settings[9]. Meanwhile, Chinese suppliers like Tianjin Pharmacn Medical Technology and Wuhan Wuyao dominate the bulk API market, producing epinephrine bitartrate at competitive prices (₹600–₹1,600/kg) while adhering to ISO 9001:2015 standards[7][11].
Lidocaine Hydrochloride Supply Chains and Market Trends
Key Suppliers and Pricing Dynamics
LGM Pharma and Moehs Iberica (Spain) are prominent lidocaine hydrochloride suppliers, with production capacities exceeding 50 metric tons annually[3][5]. The API’s price volatility—ranging from $100/kg to $500/kg—reflects fluctuations in raw material costs (e.g., xylidine derivatives) and geopolitical trade barriers[3][10]. Indian manufacturers like Symed Labs leverage cost advantages, offering lidocaine HCl at ₹750/kg ($9.50/kg) for generic drug formulations[7][10].
Innovations in Combined Formulations
Combination products, such as Lignospan Standard (lidocaine 2% with epinephrine 1:100,000), exemplify advancements in local anesthesia. Deproco Inc., through partnerships with China Drug Services, supplies this reference-listed drug (RLD) for clinical trials, emphasizing biocompatibility and shelf-life stability[8]. Such formulations require specialized manufacturing infrastructure, including nitrogen-blanketed reactors to prevent epinephrine oxidation[6][8].
Strategic Procurement and Supplier Evaluation
Digital Procurement Platforms
Platforms like PharmaCompass and PharmaOffer streamline supplier discovery by aggregating data on certifications, pricing, and production capabilities[1][2][10][11]. For example, PharmaCompass lists 47 epinephrine bitartrate suppliers and 57 lidocaine hydrochloride manufacturers, filterable by GMP status and regulatory filings[1][3]. These tools enable buyers to compare Shandong Octagon Chemicals (China) and Cambrex (Italy) side-by-side, assessing lead times and audit reports[10][11].
Risk Mitigation Strategies
Procurement teams must prioritize suppliers with redundant manufacturing sites and robust quality management systems (QMS). Pfizer Inc., for instance, mitigates supply chain disruptions through multi-site production and real-time batch monitoring[4]. Additionally, contractual agreements with third-party manufacturers like Janus Biotech should include clauses for API traceability and corrective action plans (CAPAs)[9].
Case Study: Pfizer’s Lidocaine-Epinephrine Combination
Pfizer’s Lidocaine HCl 1% with Epinephrine 1:100,000 (NDC 0409-3178-03) exemplifies best practices in combination drug manufacturing[4]. The single-dose, flip-top vial design minimizes contamination risks, while potassium metabisulfite acts as an antioxidant to stabilize epinephrine[4][6]. Priced at $335.99 per 18-unit carton, the product targets U.S. emergency medical services (EMS) providers, with distribution managed through Bound Tree Medical[4].
Conclusion
The global supply of epinephrine bitartrate and lidocaine hydrochloride hinges on a complex interplay of regulatory compliance, geographic specialization, and technological innovation. Procurement professionals must balance cost considerations with quality assurance, leveraging digital platforms to identify suppliers like Janus Biotech and Shandong Chenghui Shuangda that align with organizational needs. As demand for combined formulations grows, partnerships between innovators (e.g., Deproco Inc.) and contract manufacturers will drive advancements in local anesthetic efficacy and safety.
"Adrenaline Bitartrate Injection is a life-saving drug, but in some cases, it may cause side effects in some patients, which include..." – Janus Biotech[9]
Key Takeaways
- Regulatory Compliance: Suppliers must adhere to FDA, EMA, and WHO guidelines, with certifications like USDMF and CEP ensuring quality.
- Cost Dynamics: Asian manufacturers offer competitive pricing, while Western suppliers emphasize regulatory rigor.
- Combination Products: Innovations like Lignospan Standard highlight the need for specialized manufacturing techniques.
FAQs
-
What certifications should I verify when selecting a supplier?
Prioritize GMP, USDMF, and CEP certifications to ensure compliance with U.S. and EU standards[1][6]. -
How does epinephrine enhance lidocaine’s efficacy?
Epinephrine’s vasoconstrictive properties reduce systemic absorption, prolonging anesthetic effect[6][8]. -
Which platforms assist in supplier discovery?
PharmaCompass and PharmaOffer provide filters for GMP status, pricing, and regional availability[1][10]. -
Are Indian manufacturers reliable for bulk API procurement?
Yes, firms like Symed Labs comply with IP and USDMF standards, offering cost-effective solutions[7][10]. -
What are the risks of temperature excursions during epinephrine storage?
Degradation can occur, necessitating cold-chain logistics for bulk shipments[9][11].
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/epinephrine-bitartrate
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/epinephrine-tartrate
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/lidocaine-hydrochloride
- https://www.boundtree.com/pharmaceuticals/rx-pharmaceuticals/lidocaine-hcl-1-10mg-ml-50ml-vial-with-epinephrine/p/3178-03EA
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/lidocaine-hydrochloride-epinephrine-1
- https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f8d90500-f797-4238-8dd2-b59cbcd89d12
- https://dir.indiamart.com/impcat/lidocaine-hydrochloride.html
- https://www.chinadrugservices.com/reference-listed-drugs/lidocaine-and-epinephrine-injection.html
- https://www.janusbiotech.co.in/top-adrenaline-bitartrate-injection-supplier-manufacturer
- https://pharmaoffer.com/api-excipient-supplier/local-anesthetics/lidocaine-hydrochloride
- https://pharmaoffer.com/api-excipient-supplier/adrenergic-agents/epinephrine
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