Suppliers and packagers for MIOCHOL-E

MIOCHOL-E

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	MIOCHOL-E	acetylcholine chloride	FOR SOLUTION;OPHTHALMIC	020213	NDA	Bausch & Lomb Incorporated	24208-539-20	1 KIT in 1 BLISTER PACK (24208-539-20) * 2 mL in 1 VIAL * 2 mL in 1 AMPULE	1993-09-22

Suppliers for the Pharmaceutical Drug: Miochol-E

Last updated: July 30, 2025

Introduction

Miochol-E (acetylcholine chloride injection) is a potent pharmacological agent used primarily in ophthalmic procedures to induce miosis, facilitate intraocular surgeries, and manage certain ocular conditions. Given its critical role in delicate surgeries such as cataract extraction and other anterior segment procedures, the availability and sourcing of Miochol-E are vital for healthcare providers worldwide. This article explores the landscape of suppliers, examining manufacturing companies, distribution channels, regulatory considerations, and the industry dynamics influencing supply chains for Miochol-E.

Product Overview and Market Significance

Miochol-E is a synthetic acetylcholine chloride solution designed for rapid onset and reversible miosis during ocular surgeries. Its utility hinges on its efficacy and predictability, necessitating high-quality manufacturing standards compliant with international regulatory frameworks. The drug’s niche application fosters a specialized supply ecosystem dominated by a few key manufacturers, with distribution networks spanning globally.

The global ophthalmic pharmaceutical market is projected to grow significantly, driven by aging populations and rising prevalence of cataract and glaucoma conditions. Consequently, Miochol-E remains an essential component, often supplied through regional and international drug manufacturers. Its critical role underscores the importance of reliable sourcing for ophthalmic surgical centers.

Key Manufacturers and Suppliers of Miochol-E

1. Bausch + Lomb (AbbVie Inc.)

Overview:
Bausch + Lomb, now under the umbrella of AbbVie Inc., acts as a leading supplier and manufacturer of Miochol-E. Historically, Bausch + Lomb has been a pioneer in ophthalmic solutions, emphasizing high standards and consistent product quality.

Manufacturing & Distribution:
Bausch + Lomb produces Miochol-E under strict GMP (Good Manufacturing Practice) guidelines to ensure purity and efficacy. Their distribution network spans North America, Europe, and parts of Asia. In some territories, Miochol-E is supplied directly via regional distributors authorized by Bausch + Lomb.

Regulatory Approvals:
Miochol-E retains approval from major regulatory bodies such as the FDA (Food and Drug Administration, USA), EMA (European Medicines Agency), and respective health authorities in Asian and Middle Eastern markets.

2. Akorn, Inc.

Overview:
Akorn is an American pharmaceutical firm specializing in sterile ophthalmic solutions. The company produces a generic equivalent for Miochol-E and has historically supplied acetylcholine chloride formulations.

Manufacturing & Distribution:
Akorn’s manufacturing facilities are FDA-approved, adhering to stringent quality controls. Their distribution channels serve North American markets extensively, with a growing footprint in international markets through partnerships and distributors.

Regulatory & Supply Considerations:
Akorn’s generic acetylcholine chloride faces patent and regulatory challenges in some territories, impacting availability in certain regions.

3. CENEXI

Overview:
CENEXI, a France-based pharmaceutical manufacturer, supplies sterile injectable products, including acetylcholine formulations. Though primarily serving European markets, CENEXI’s products are exported globally, often through partnerships with regional distributors.

Manufacturing & Regulatory Status:
CENEXI’s manufacturing complies with European GMP standards, and their products are approved by European and other international regulatory agencies.

4. Other Regional Suppliers

In addition to the predominant manufacturers, certain countries have localized suppliers or compounding pharmacies offering customized formulations of acetylcholine chloride, often in regions where access to global brands is limited. These alternative sources are typically subject to regulatory scrutiny and vary in quality assurance.

Distribution Channels and Supply Chain Dynamics

Global Supply Chain Overview

The supply of Miochol-E involves complex logistics, often centered around regional manufacturing hubs and distribution entities. Major ophthalmic supply companies and hospital-based distributors typically stock Miochol-E, sourcing directly from manufacturers or authorized wholesalers.

Regulatory Influences

Regulatory approvals influence the ease and speed of procurement. Manufacturers must navigate global compliance standards, including FDA approvals in the US, EMA certification in Europe, and corresponding agencies in Asia, the Middle East, and Africa. Export restrictions, import licensing, and local manufacturing laws may further impact availability.

Challenges in Supply

• Limited Manufacturers: The market’s specialized nature means few producers, risking supply disruptions if manufacturing issues arise.
• Regulatory Delays: Changes in approval status or regulatory policies can delay or restrict supply.
• Pricing & Reimbursement: Variability in pricing strategies influences distribution choices, with some regions favoring cheaper generics or compounded formulations.
• Global Events: Supply chain disruptions due to geopolitical tensions, pandemics, or logistical challenges impact availability.

Regulatory and Quality Assurance Considerations

The critical importance of safety and efficacy mandates rigorous quality controls. Manufacturers adhering to WHO GMP standards or equivalent are preferred suppliers. Their products undergo stringent testing for sterility, potency, and stability. Hospitals and surgical centers often prefer suppliers with strong regulatory recognition and transparent quality records.

Future Outlook for Miochol-E Suppliers

The upcoming landscape anticipates increased demand for ophthalmic surgical supplies driven by technological advancements and aging demographics. Suppliers investing in R&D, expanding manufacturing capacity, and securing regulatory approvals are poised to dominate future markets.

Furthermore, biosimilar and generic entrants are likely to influence pricing and availability dynamics. The continuation of global health initiatives aimed at reducing surgical costs and increasing access also may foster local production, especially in emerging markets.

Key Takeaways

• Limited but Concentrated Supplier Base: Miochol-E’s supply relies heavily on a handful of manufacturers, primarily Bausch + Lomb and Akorn, ensuring quality but risking supply concentration.
• Regulatory Compliance Is Paramount: Suppliers must meet rigorous international standards, with regulatory approvals serving as key indicators of product reliability.
• Supply Chain Resilience Is Critical: Disruptions in manufacturing, logistics, or regulatory approvals can impact availability, emphasizing the importance of diversified sourcing.
• Emerging Markets Present Opportunities: Local production or regional suppliers may bridge gaps, especially in regions with limited access to global brands.
• Innovation and Expansion Will Shape Future Supply: Increased demand driven by aging populations and technological advances will necessitate expanded manufacturing and broader supplier networks.

FAQs

Q1: Who are the main global manufacturers of Miochol-E?
A1: The primary manufacturers are Bausch + Lomb (AbbVie Inc.) and Akorn, along with regional suppliers like CENEXI in Europe. These firms adhere to strict quality standards and hold regulatory approvals relevant to their markets.

Q2: How does regulatory approval influence Miochol-E supply?
A2: Regulatory approvals ensure product safety and efficacy, enabling manufacturers to sell in specific markets. Delays or restrictions in approvals can hinder supply or increase costs.

Q3: Are there generic alternatives to Miochol-E?
A3: Yes, companies like Akorn produce generic acetylcholine chloride injections. However, availability depends on regional patent laws and regulatory decisions.

Q4: What challenges threaten the supply stability of Miochol-E?
A4: Challenges include manufacturing disruptions, regulatory delays, logistical issues, and limited supplier diversity, all of which can impact continuous supply.

Q5: How might emerging markets influence Miochol-E supply trends?
A5: Rising demand and the growth of local manufacturing initiatives can diversify supply channels, reduce costs, and improve access in emerging regions.

References

[1] MarketWatch. "Ophthalmic Drugs Market Forecast." 2022.
[2] U.S. Food & Drug Administration. "Drug Approvals and Labeling." 2022.
[3] European Medicines Agency. "Authorized Human Medicines." 2022.
[4] Bausch + Lomb. "Product Information and Approvals." 2022.
[5] Akorn Inc. Official Website. "Product Overview." 2022.