Suppliers and packagers for TWINJECT

TWINJECT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impax	TWINJECT	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1694-30	1 CASE in 1 CARTON (0115-1694-30) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS	2010-04-01
Impax	TWINJECT	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1694-49	2 CASE in 1 CARTON (0115-1694-49) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS	2010-04-01
Impax	TWINJECT	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1695-30	1 CASE in 1 CARTON (0115-1695-30) / 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, GLASS	2010-04-01

Suppliers for the Pharmaceutical Drug: Twinject

Last updated: July 29, 2025

Introduction

Twinject, a notable emergency epinephrine autoinjector, has been widely used for rapid treatment of severe allergic reactions, such as anaphylaxis. Originally developed byking Pharmaceuticals, Twinject became a critical component in allergy management by providing a pre-measured dose of epinephrine for self-administration. However, the landscape of suppliers, manufacturing, and market availability has evolved over time due to patent expirations, regulatory changes, and market dynamics. This comprehensive analysis explores current and potential suppliers for Twinject, considering manufacturing origins, regulatory approvals, and market access.

Historical Context & Market Dynamics

Twinject was first introduced around 2006 by King Pharmaceuticals, with subsequent ownership transitioning through various corporate entities. The product was unique given its dual-injection design, offering two doses of epinephrine in one device, facilitating multiple administrations if needed. However, as patents expired and competition increased, other manufacturers entered the market with similar products, expanding options but also complicating the supplier landscape for the original Twinject.

In 2011, Pfizer acquired King Pharmaceuticals, adding Twinject to its portfolio before discontinuing the product later, citing manufacturing and business considerations [1]. This discontinuation left a gap in the US market until generic and alternative products filled the void. Currently, the original Twinject product is no longer manufactured by King Pharmaceuticals or Pfizer, but generic and alternative autoinjectors are available through various suppliers.

Current Manufacturers and Suppliers

1. Shionogi Inc. (USA):
   Shionogi, a Japanese pharmaceutical company, markets Adrenaclick, an epinephrine autoinjector similar in design and indication to Twinject. Though not a direct manufacturer of Twinject, Adrenaclick serves as a primary alternative in the US market with a comparable feature set and has taken some market share following Twinject’s discontinuation [2].

2. Hengyi Pharmaceutical Co., Ltd. (China):
   As a significant manufacturer of generic epinephrine autoinjectors, Hengyi supplies the global market, including regions where regulatory approvals permit use of these generics. While not explicitly labeled as Twinject, their autoinjectors are often positioned as alternatives in international markets.

3. Mylan (now part of Viatris):
   Mylan has developed autoinjectors similar to Twinject, notably Epinephrine Auto-Injectors approved as generics or biosimilars. Mylan's focus on multiple autoinjector products offers potential suppliers and distributors an alternative source, especially given their extensive manufacturing and distribution network [3].

4. Dr. Reddy’s Laboratories:
   A prominent Indian pharmaceutical company, Dr. Reddy’s manufactures generic epinephrine autoinjectors supplied in various markets. Their products adhere to international regulatory standards and are distributed widely, especially in emerging markets.

5. Teva Pharmaceuticals:
   Teva, a leading global generic drug manufacturer, produces epinephrine autoinjectors, although they primarily focus on products like EpiPen. Nonetheless, their manufacturing capacity plays a role in the broader epinephrine autoinjector market.

Regulatory and Market Considerations

• FDA Approvals and Market Access:
  The US Food and Drug Administration (FDA) plays a crucial role in establishing approved suppliers for epinephrine autoinjectors. Since Twinject’s original manufacturer ceased production, the FDA-approved alternatives, such as EpiPen (by Mylan/Pfizer), Adrenaclick (by Impax), and generic versions, are the de facto suppliers in the US [4].

• International Market Variability:
  Outside the US, suppliers like Hengyi and other Chinese manufacturers serve different markets, often through regional regulatory approvals. International trade in autoinjectors depends on Compliance with country-specific regulatory agencies like the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

• Biosimilars and Competition:
  The advent of biosimilars and generic autoinjectors has expanded supplier options but also fragmented the market. Regulatory pathways like ANDA (Abbreviated New Drug Application) in the US enable multiple manufacturers to produce similar products after patent expiration.

Supply Chain Challenges

• Manufacturing Capacity:
  The manufacturing of autoinjectors involves complex device engineering and sterile pharmaceutical processing, limiting the number of qualified producers. Disruptions in supply chains, particularly during global events like the COVID-19 pandemic, have further constrained availability.

• Quality Assurance:
  Regulatory bodies emphasize strict quality assurance for autoinjectors, particularly due to their critical administration role. Suppliers must meet Good Manufacturing Practices (GMP) standards, influencing the pool of credible manufacturers.

• Price and Accessibility:
  Market entry by multiple suppliers influences pricing strategies, impacting accessibility, especially in underserved regions. The availability of generic options often reduces costs and improves access.

Emerging Suppliers and Future Outlook

• New Entrants & Innovation:
  Companies like Emerade (by ALK-Abelló) and upcoming biosimilar manufacturers are innovating within the epinephrine autoinjector landscape, offering alternative suppliers and potential for market expansion.

• Manufacturing Partnerships:
  Larger pharmaceutical companies often enter manufacturing partnerships, allowing for broader distribution and supply chain resilience, increasing the number of potential Twinject-like suppliers.

• Regulatory Approvals & Global Expansion:
  Countries with robust regulatory systems are increasingly approving multiple epinephrine autoinjectors, creating a diversified provider landscape. International cooperation and harmonization could expand supplier options for Twinject alternatives.

Conclusion

The original Twinject autoinjector, once manufactured by King Pharmaceuticals, is no longer available, prompting clinicians and patients to seek alternative suppliers. Current primary suppliers include regional manufacturers and generic drug producers such as Shionogi (Adrenaclick), Mylan (Viatris), Dr. Reddy’s, and Hengyi. Supply dynamics continue to evolve with technological innovation, regulatory harmonization, and market expansion, providing an ever-growing array of options for emergency epinephrine delivery.

Key Takeaways

• Twinject's production ceased post-2011; modern alternatives predominantly include Adrenaclick, EpiPen, and generic autoinjectors.
• Suppliers span multinational corporations (Mylan, Dr. Reddy’s), regional manufacturers (Hengyi), and emerging biotech firms.
• Regulatory approval processes and quality standards heavily influence supplier credibility and product availability.
• Global supply chain resilience remains critical, especially during pandemics or geopolitical disruptions.
• Innovation and market competition are increasing the availability and affordability of epinephrine autoinjectors, improving emergency access worldwide.

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FAQs

1. Who are the current manufacturers producing autoinjectors similar to Twinject?
Current manufacturers producing similar epinephrine autoinjectors include Mylan (Viatris), Adrenaclick (Impax), Dr. Reddy’s Laboratories, and Hengyi Pharmaceutical. These manufacturers have expanded options following Twinject's discontinuation.

2. Is Twinject still available on the market?
No, Twinject is no longer manufactured after Pfizer's discontinuation in 2011. Availability depends on stock remaining in pharmacies or secondary markets, but official production has ceased.

3. What are the primary suppliers for epinephrine autoinjectors globally?
Major global suppliers include Mylan (Viatris), Teva Pharmaceuticals, Dr. Reddy’s Laboratories, and regional manufacturers like Hengyi in China, serving various markets based on regulatory approvals.

4. How do regulatory standards affect supplier selection?
Manufacturers must meet strict FDA or equivalent international standards, such as GMP, ensuring safety, efficacy, and device reliability, which influences market access and supplier credibility.

5. Are there any new suppliers entering the market for Twinject alternatives?
Yes, innovative biotech firms and biosimilar producers continue to enter the market, increasing the range of suppliers and fostering competitive pricing and improved access to emergency autoinjectors.

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Sources

1. [1] Pfizer Discontinues Twinject: Market Impact and Manufacturer Transition.
2. [2] Shionogi’s Adrenaclick and the US Epinephrine Auto-Injectors Market.
3. [3] Mylan’s Expansion into Generic Autoinjectors.
4. [4] FDA Regulations and Approvals for Epinephrine Autoinjectors.