Suppliers and packagers for miostat

miostat

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon	MIOSTAT	carbachol	SOLUTION;INTRAOCULAR	016968	NDA	Alcon Laboratories, Inc.	0065-0023-15	12 VIAL, GLASS in 1 CARTON (0065-0023-15) / 1.5 mL in 1 VIAL, GLASS	1974-04-15

Suppliers for the Pharmaceutical Drug: MIOSTAT (Miochol-E)

Last updated: August 3, 2025

Introduction

MIOSTAT, commercially known as Miochol-E, is a pharmaceutical formulation containing acetylcholine chloride used primarily in ophthalmology for intraoperative miosis. It facilitates ocular surgeries by constricting the pupil rapidly and transiently. As a specialized pharmacological agent, the supply chain for Miochol-E involves multiple dimensions—manufacturers, authorized distributors, regional suppliers, and regulatory considerations. Accurate identification of suppliers and understanding the global supply framework are essential for healthcare providers, pharmaceutical companies, and regulators.

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Overview of Miochol-E and Its Market

Miochol-E is considered a high-precision, localized drug with a narrow scope of use—predominantly in ophthalmic surgical procedures like cataract extraction and vitrectomy. Its active component, acetylcholine chloride, is a cholinergic agonist inducing miosis temporarily during surgery.

Production is limited given its specialized nature, and the global supply hinges largely on a handful of manufacturers with approved manufacturing licenses, predominantly in the United States, Europe, and some Asian countries. The drug’s market is characterized by tight regulation, high quality standards, and limited regional availability, with supply primarily routed through authorized channels.

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Major Manufacturers and Suppliers

1. Bausch + Lomb Incorporated

Overview:
Bausch + Lomb, a leading global eye health company, is the primary manufacturer of Miochol-E. The company holds the original patent rights and manufacturing licenses for Miochol-E, with its headquarters situated in the United States.

Supply Credentials:

• Authorized supplier of Miochol-E globally, adhering to stringent FDA and EMA regulatory standards.
• Production facilities in the United States ensure high quality and regulatory compliance (21 CFR part 211 standards).
• The company distributes primarily through approved ophthalmic wholesalers and directly to hospitals, clinics, and surgical centers.

Market Presence:

• Established supplier with consistent availability within North America and expanding distribution in Europe and select Asia-Pacific markets.
• Bausch + Lomb maintains a global network of distribution partners subject to regional licensing agreements.

2. Other Authorized European and Asian Distributors

While Bausch + Lomb is the principal producer, regional distributors and authorized partners facilitate localized supply, particularly in Europe, Asia, and emerging markets.

European Suppliers:

• Limited regional distributors with licensing agreements to distribute Miochol-E within the European Union, compliant with EMA standards.
• Suppliers often stock the product in hospitals or through ophthalmic surgical product distributors.

Asian Suppliers:

• In countries like Japan, China, and India, regional pharmaceutical distributors may import Miochol-E directly from licensed European or American distributors.
• Some local pharmaceutical companies may produce acetylcholine chloride formulations under strict licensing, but these are often not equivalent to Miochol-E and lack the specific patent-based formulation.

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Regulatory Aspects and Licensing

The supply and distribution of Miochol-E are governed by strict regulatory frameworks. In the United States, FDA approval (NDA 205832) authorizes Bausch + Lomb to market Miochol-E. Similar approvals exist across the European Union via EMA registration.

Import permits, Good Manufacturing Practice (GMP) compliance, and regional health authority approvals are mandatory for wholesalers and distributors. Regional disparities in regulatory approval can influence supply chain robustness:

• In the U.S.:
  Bausch + Lomb is the sole legal manufacturer and supplier.

• In Europe:
  Distribution licenses are granted to regional wholesalers under EMA’s centralized or mutual recognition procedures.

• In Asia:
  Some regional manufacturers may import the product, with local regulatory agencies overseeing licensing, but genuine Miochol-E supply is limited, and counterfeit risks exist.

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Supply Chain Challenges

Limited Production Capacity:
The niche application and complex manufacturing process restrict production scales, leading to potential shortages during high-demand periods.

Regulatory Barriers:
Stringent licensing and import restrictions can delay supply in certain regions, especially where regional drug approvals are pending.

Counterfeit and Unauthorized Suppliers:
The high-value ophthalmic product is susceptible to counterfeit markets, emphasizing procurement through verified channels. Purchasing from unapproved suppliers risks substandard formulations and regulatory violations.

COVID-19 Impact:
Disruptions in global logistics, manufacturing delays, and increased demand have temporarily impacted supply stability for Miochol-E in some regions.

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Emerging Alternatives and Patent Expirations

While Miochol-E remains a primary product for intraoperative miosis, ongoing research for alternatives includes neuromuscular agents and other cholinergic drugs with similar profiles. Patent expirations could influence the entry of generics or biosimilars, expanding supplier options in the future.

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Key Considerations for Stakeholders

• Ensure procurement from licensed, authorized distributors to avoid counterfeit risks.
• Monitor regional regulatory changes impacting licensing and distribution.
• Establish robust supply agreements with primary manufacturers like Bausch + Lomb.
• Consider regional supplier capabilities and regulatory compliance when planning procurement strategies.
• Stay updated on emerging generics or biosimilars that could alter the supply landscape.

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Key Takeaways

• Bausch + Lomb is the primary and authorized manufacturer of Miochol-E worldwide.
• Supply is governed by strict regulatory approvals, with regional distributors acting as intermediaries.
• Regional supply constraints and regulatory barriers can challenge consistent availability.
• Procurement should focus on licensed suppliers to mitigate counterfeit and quality issues.
• Future market dynamics may evolve with patents expiring and new formulations entering the market.

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FAQs

1. Who are the primary suppliers of Miochol-E?
Bausch + Lomb is the exclusive manufacturer authorized to produce and distribute Miochol-E globally, with regional distributors and licensed partners handling local supply.

2. Can Miochol-E be obtained through wholesale distributors outside of Bausch + Lomb?
Yes, through authorized regional distributors and licensed supply channels, but these are typically closely regulated and limited to approved providers.

3. Are there alternative drugs to Miochol-E for intraoperative miosis?
While alternative agents exist, Miochol-E remains the most widely used. Research into biosimilars or generics is ongoing, but current supply is largely from Bausch + Lomb.

4. What regulatory considerations should buyers be aware of?
Procurement must comply with local licensing, import permits, and GMP standards. Unauthorized suppliers pose significant risks of counterfeit products.

5. How might supply chain disruptions impact Miochol-E availability?
Global manufacturing capacity, regulatory hurdles, and logistical disruptions like those caused by COVID-19 can cause temporary shortages.

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References

1. Bausch + Lomb Official Website. Miochol-E Product Information. (2023).
2. U.S. Food and Drug Administration (FDA). Miochol-E NDA 205832 approval documents. (2022).
3. European Medicines Agency (EMA). Regulatory status of Miochol-E in the EU. (2023).
4. World Health Organization. Ophthalmic drug market overview. (2022).
5. Industry reports and market analysis documents on ophthalmic pharmaceuticals.