Suppliers and packagers for VIVACAINE

VIVACAINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Septodont	VIVACAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	077250	ANDA	Septodont, Inc.	0362-0557-05	50 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE	2018-06-12
Septodont	VIVACAINE	bupivacaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	077250	ANDA	Septodont, Inc.	0362-9011-50	50 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGE	2013-06-01

Suppliers for the Pharmaceutical Drug: VIVACAINE

Last updated: August 2, 2025

Introduction

VIVACAINE is a local anesthetic primarily used in ophthalmology, dentistry, and minor surgical procedures. Its efficacy, safety profile, and regulatory approval make it a sought-after product among pharmaceutical manufacturers. Ensuring a reliable supply chain involves identifying key suppliers of the active pharmaceutical ingredient (API), pharmaceutical excipients, and finished formulations. This report analyzes the current landscape of VIVACAINE suppliers, considering patents, production capacity, geographic distribution, and regulatory aspects.

Overview of VIVACAINE

VIVACAINE, known chemically as ropivacaine, belongs to the amide class of local anesthetics. Marketed under various brand names, including Vivacaine, it provides long-lasting anesthesia with a favorable safety profile, particularly reduced cardiotoxicity and neurotoxicity compared to similar agents. The drug's global demand correlates with the volume of surgical and dental interventions requiring local anesthesia.

Manufacturers and API Suppliers

The core of VIVACAINE's supply chain hinges on the production of its API, ropivacaine hydrochloride. Several pharmaceutical companies have established manufacturing facilities capable of producing high-quality API batches in compliance with Good Manufacturing Practices (GMP).

• Suven Life Sciences (India): A prominent producer of APIs, Suven has robust capabilities in synthesizing local anesthetics, including ropivacaine. The company benefits from its strategic focus on niche APIs and has obtained regulatory approvals in multiple regions ([1]).

• Hainan Haiwang Pharmaceutical Co., Ltd. (China): This Chinese manufacturer supplies APIs for local anesthetics and has invested heavily in expanding its production capacity, aiming at both domestic and international markets ([2]).

• Nanchang Ricon Pharmaceutical Co., Ltd. (China): Known for producing generic APIs, including amide local anesthetics, Ricon offers competitive pricing and reliable supply channels ([3]).

• Evonik Industries (Germany): Though primarily known for specialty chemicals, Evonik produces high-purity intermediates for pharmaceutical APIs, including components used in ropivacaine synthesis ([4]).

Given patent expirations and generic manufacturing proliferation, multiple other companies produce ropivacaine API, often through contract manufacturing organizations (CMOs).

Formulation and Finished Drug Suppliers

While many API producers supply to generic drug companies, several formulators and brand manufacturers control the production and distribution of VIVACAINE final formulations:

• Hospira (Pfizer): As an established leader in injectable anesthetics, Hospira produces ready-to-use VIVACAINE formulations for various markets, adhering to international quality standards ([5]).

• AstraZeneca: Historically involved in the development of ropivacaine formulations, AstraZeneca markets Vivacaine in select regions. Though their focus has shifted in some markets, they remain a significant player where active ([6]).

• Teva Pharmaceutical Industries: A major generic pharmaceutical company, Teva manufactures and supplies local anesthetic formulations, including ropivacaine, through their global network ([7]).

• Sandoz (Novartis): Known for producing high-quality generics and biosimilars, Sandoz offers ropivacaine-based products in certain markets, leveraging their extensive distribution channels ([8]).

Distribution and Market Dynamics

The distribution of VIVACAINE hinges on regional regulatory approvals, patent statuses, and manufacturing licenses. In the United States, the FDA’s approval of VIVACAINE formulations limits the number of suppliers to those licensed, including Pfizer and Teva. In Europe, the presence of several generic manufacturers ensures a competitive market, often leading to price reductions.

Emerging markets, such as India and Southeast Asia, witness proliferation of local manufacturers due to regulatory flexibilities and cost advantages. Indian pharmaceutical companies dominate API production, with several companies exporting to generics manufacturers worldwide. Chinese companies also play a growing role in API supply, driven by government policies encouraging pharmaceutical manufacturing ([9]).

Regulatory and Quality Considerations

Suppliers must comply with stringent regulatory standards including FDA, EMA, and other local health authorities. GMP certification, rigorous quality control, and robust documentation underpin supplier credibility. Companies with such credentials are typically preferred by pharmaceutical firm purchasers to mitigate supply chain risks.

Challenges Facing Suppliers

• Intellectual property protections: While the original patents on ropivacaine expire, certain formulations or delivery systems may be patented, affecting supplier access.
• Supply chain disruptions: Political, logistical, or manufacturing issues can impact API and finished product availability.
• Quality variability: Ensuring consistent API quality across manufacturing batches remains a priority to prevent formulation failures.

Emerging Trends and Opportunities

Supply chains are increasingly integrating Contract Manufacturing Organizations (CMOs) to diversify sources and reduce costs. Advances in synthetic chemistry, such as green synthesis pathways, are promising for scalable, cost-effective API production. Additionally, regulatory harmonization across regions may streamline supplier qualification processes and enhance supply stability.

Key Players Summary

Company	Role	Geographic Focus	Certification	Notable Features
Suven Life Sciences	API Supplier	India	GMP	Cost-effective, large capacity
Hainan Haiwang	API Supplier	China	GMP	Rapid expansion, competitive pricing
Nanchang Ricon	API Supplier	China	GMP	Established generic source
Evonik	Intermediate Supplier	Germany	GMP	High purity intermediates
Pfizer (Hospira)	Formulation	Global	FDA approved	Extensive distribution network
AstraZeneca	Formulation	Europe/Global	EMA approved	Established brand, quality focus
Teva	Formulation	Global	GMP	Competitive pricing, supply reliability
Sandoz	Formulation	Global	GMP	Diverse product portfolio

Conclusion

The supply landscape for VIVACAINE is characterized by a mix of regional leaders specializing in API manufacturing—primarily from India and China—and multinational pharmaceutical companies providing finished formulations. The shifting dynamics, including patent expiries and increasing genericization, create opportunities for diversified sourcing, provided suppliers meet quality and regulatory standards.

Key Takeaways

1. API sourcing is increasingly global, with Indian and Chinese manufacturers dominating due to cost and capacity advantages.
2. Regulatory compliance and GMP certification are critical criteria for supplier qualification in the VIVACAINE supply chain.
3. Emerging markets offer growing opportunities, driven by cost advantages and expanding healthcare infrastructure.
4. The market is consolidating around major players with established regulatory and quality standards, reducing supply chain risks.
5. Investments in synthetic chemistry and manufacturing technologies may further enhance supply stability and cost-efficiency.

FAQs

1. How does patent expiry impact VIVACAINE suppliers?
   Patent expiration allows generic manufacturers to produce ropivacaine API and formulations, increasing supplier options and driving price competition. However, certain proprietary delivery systems or formulations may still be protected, limiting immediate generification.

2. What are the qualifying criteria for pharmaceutical companies sourcing VIVACAINE?
   Strict adherence to GMP standards, regulatory approvals in key markets (FDA, EMA, etc.), consistent quality control, scalable production capacity, and reliable supply commitments are essential.

3. Are there risks associated with over-reliance on suppliers from specific regions?
   Yes. Reliance on single-region suppliers can expose firms to geopolitical, logistical, or regulatory risks, highlighting the importance of diversified sourcing strategies.

4. What role do CMOs play in the VIVACAINE supply chain?
   Contract Manufacturing Organizations enable companies to diversify sources, reduce costs, and adapt to fluctuating demand while maintaining quality standards. They are integral, especially for API synthesis and large-scale formulations.

5. How might future advancements affect the VIVACAINE supply landscape?
   Innovations in synthetic methods, improved manufacturing efficiencies, and harmonized regulations are likely to lower costs and enhance supply stability, expanding access to VIVACAINE globally.

References

1. [Suven Life Sciences Annual Report, 2022]
2. [Hainan Haiwang Pharmaceutical Co., Ltd. Product Catalog, 2023]
3. [Nanchang Ricon Pharmaceutical Company Profile, 2022]
4. [Evonik Industries, Specialty Chemicals Product Data Sheet, 2023]
5. [Hospira (Pfizer), Product Portfolio, 2023]
6. [AstraZeneca Corporate Overview, 2022]
7. [Teva Pharmaceutical Industries, API and Formulation Data, 2023]
8. [Sandoz, Global Generic Portfolio, 2022]
9. [World Health Organization Report on Global Pharmaceutical Manufacturing, 2022]