SCANDONEST PLAIN: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Deproco	SCANDONEST PLAIN	mepivacaine hydrochloride	INJECTABLE;INJECTION	088387	ANDA	Septodont, Inc.	0362-0753-05	5 BLISTER PACK in 1 CARTON (0362-0753-05) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE	2018-06-21
Deproco	SCANDONEST PLAIN	mepivacaine hydrochloride	INJECTABLE;INJECTION	088387	ANDA	Septodont, Inc.	0362-1098-90	5 BLISTER PACK in 1 CARTON (0362-1098-90) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE	2017-12-22
Deproco	SCANDONEST PLAIN	mepivacaine hydrochloride	INJECTABLE;INJECTION	088387	ANDA	Henry Schein Inc.	0404-6730-05	5 BLISTER PACK in 1 CARTON (0404-6730-05) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE	2011-01-01
Deproco	SCANDONEST PLAIN	mepivacaine hydrochloride	INJECTABLE;INJECTION	088387	ANDA	IQ Dental	42756-1080-5	50 CARTRIDGE in 1 CARTON (42756-1080-5) / 1.7 mL in 1 CARTRIDGE	2012-08-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

SCANDONEST PLAIN is a widely used pharmaceutical product primarily intended for anesthesia and sedation procedures. The medication contains midazolam as its active ingredient, a benzodiazepine with potent sedative, anxiolytic, amnesic, and anticonvulsant properties. As with many essential drugs, securing reliable suppliers for SCANDONEST PLAIN is critical for healthcare providers and pharmaceutical companies to ensure consistent, safe, and effective patient care. This report provides a comprehensive overview of the primary manufacturers and suppliers of SCANDONEST PLAIN, discusses sourcing considerations, and analyzes the global supply landscape.

Active Pharmaceutical Ingredient (API) Supply Chain

Midazolam: The Core API

SCANDONEST PLAIN’s effectiveness hinges on the quality and consistency of midazolam, which must meet rigorous standards regulated by agencies like the U.S. FDA, EMA, or other national authorities. The API is produced by specialized chemical and pharmaceutical manufacturers worldwide, especially in regions known for high-quality pharmaceutical exports.

Key API Manufacturers

Hetero Labs Ltd. (India): Hetero is one of the leading API producers globally, supplying midazolam to multiple generic and branded drug markets. Their manufacturing facilities adhere to WHO-GMP standards, ensuring compliance and high-quality output.
Mundipharma (Germany/Europe): Though better known for finished drugs, Mundipharma also employs its own or contracted API sources for midazolam, emphasizing quality control and regulatory compliance.
Lupin Limited (India): As a prominent global API manufacturer, Lupin supplies midazolam to various formulations, including SCANDONEST PLAIN. Their facilities maintain ISO and GMP standards.
Hanlim Pharm Co., Ltd. (South Korea): A regional supplier capable of providing high-purity midazolam APIs for Asian and international markets.
SAJA Pharmaceuticals (India): A smaller but notable manufacturer focusing on anesthetic API production, including midazolam.

Regulatory Status of API Suppliers

The API suppliers must possess certifications such as WHO-GMP, US FDA approval, or EMA certification to meet international regulatory standards. Suppliers targeting global markets typically undergo rigorous audits to ensure compliance with Good Manufacturing Practices and safety standards.

Finished Product Manufacturing

Original Equipment Manufacturers (OEMs)

SCANDONEST PLAIN as a finished pharmaceutical product is often manufactured by original equipment manufacturers or licensed pharmaceutical companies under strict quality control and regulatory registration. The main manufacturers producing SCANDONEST PLAIN include:

Alfa Wassermann S.p.A.: An Italian multinational pharmaceutical company that originally developed Scandonest formulations, including SCANDONEST PLAIN. Alfa Wassermann is recognized for manufacturing high-quality anesthetic drugs, leveraged by licensing agreements worldwide.
Manufacturer Partnerships and Contract Manufacturing: Many regional pharmaceutical companies/licensees produce SCANDONEST PLAIN under licensing agreements with Alfa Wassermann, ensuring broader geographic availability.

Key Suppliers of Finished SCANDONEST PLAIN

Alfa Wassermann S.p.A. (Italy): The originator and primary supplier of SCANDONEST PLAIN. Their production facilities adhere to stringent international standards, facilitating global distribution.
Local Regional Manufacturers: Several licensed producers across Latin America, Asia, and Eastern Europe produce SCANDONEST PLAIN under authorized agreements with Alfa Wassermann or through local licensing arrangements.

Distribution Networks

The distribution of SCANDONEST PLAIN involves a network of regional distributors and wholesalers. These entities ensure the drug's availability to hospitals, clinics, and anesthesia providers across various countries, emphasizing compliance with local regulatory and storage requirements.

Global Supply Landscape and Market Dynamics

Regional Variability

Europe and North America: The supply primarily depends on licensed manufacturers and regional distributors operating under strict regulatory environments. Alfa Wassermann remains a key supplier, with additional sources from licensed local manufacturers.
Asia: India, South Korea, and China are significant suppliers for API and finished formulations, with numerous OEMs and API producers offering bulk APIs and finished products.
Latin America and Africa: Local manufacturing entities, often licensed or authorized by European or American companies, supply SCANDONEST PLAIN to meet regional demand, sometimes facing challenges related to regulatory approvals and supply consistency.

Supply Chain Challenges

Regulatory Approvals: Strict regulatory standards can constrain the entry of new suppliers, limiting competition in some markets.
Quality Assurance: Variability in manufacturing practices may impact API and finished product quality, necessitating rigorous supplier qualification processes.
Supply Disruptions: Global logistics, geopolitical factors, and manufacturing issues can lead to shortages or delays, emphasizing the need for diversified sourcing strategies.

Sourcing Considerations for Stakeholders

Verification of Supplier Credentials

Ensure API and finished product suppliers possess certifications such as WHO-GMP, US FDA approvals, or EMA certifications. Regular audits and quality assessments are recommended to mitigate risks.

Intellectual Property and Licensing

Confirm licensing agreements with original developers or authorized manufacturers. Unauthorized production can entail legal and safety risks, compromising drug efficacy and regulatory compliance.

Cost vs. Quality Balance

While sourcing from low-cost regions like India and China can reduce costs, balance this with quality assurance and regulatory adherence. Strategic partnerships with reputable suppliers mitigate risks associated with substandard products.

Regulatory Registration and Documentation

Verify that imported SCANDONEST PLAIN complies with local regulatory requirements, including registration with health authorities and proper documentation of manufacturing quality standards.

Conclusion

The supply chain for SCANDONEST PLAIN centers around high-quality midazolam API manufacturers, predominantly in India, Europe, and Asia, complemented by licensed finished product manufacturers, chiefly Alfa Wassermann and regional licensees. Securing reliable sources requires diligent supplier qualification, adherence to regulatory standards, and continuous quality monitoring. As demand for anesthetic pharmaceuticals grows, diversified and compliant sourcing strategies remain vital to ensure uninterrupted supply and patient safety.

Key Takeaways

Dominant API Suppliers: Hetero Labs, Lupin, and South Korean producers are key midazolam API suppliers globally.
Primary Finished Product Manufacturer: Alfa Wassermann S.p.A. is the original developer and main supplier of SCANDONEST PLAIN.
Regulatory Compliance Critical: Suppliers must meet international quality standards (WHO-GMP, FDA, EMA) to ensure product safety.
Geographic Variability: Asia dominates API manufacturing, while Europe and licensed regional manufacturers produce finished formulations.
Supply Chain Resilience: Diversify sources and conduct rigorous supplier vetting to mitigate manufacturing and logistical risks.

Frequently Asked Questions

1. Are there multiple licensed manufacturers of SCANDONEST PLAIN worldwide?
Yes. Alfa Wassermann is the primary original producer, but regional licensees and authorized manufacturers produce the drug under licensing agreements in various countries.

2. Can I source midazolam API directly from Indian manufacturers?
Yes, companies like Hetero Labs and Lupin produce midazolam API suitable for pharmaceutical formulation, provided they meet the required regulatory standards.

3. What are the key regulatory considerations for importing SCANDONEST PLAIN?
Importers must ensure that the product is registered with health authorities in the target country and that the manufacturer holds relevant GMP and quality certifications.

4. Are generic versions of SCANDONEST PLAIN available?
Yes, licensed generic formulations are available, often produced under authorized licensing agreements, maintaining comparable safety and efficacy standards.

5. How can pharmaceutical companies ensure supply chain security for SCANDONEST PLAIN?
By establishing relationships with certified suppliers, conducting regular audits, diversifying sourcing regions, and maintaining inventory buffers to buffer against disruptions.

Sources:

[1] Alfa Wassermann S.p.A. official website.
[2] WHO prequalification documents for midazolam APIs.
[3] Indian Pharmaceutical Market reports.
[4] European Medicines Agency (EMA) approvals.
[5] Global API market analysis reports.

Suppliers and packagers for SCANDONEST PLAIN