Last updated: February 20, 2026
DIASTAT ACUDIAL, a combination product of phenobarbital and dextroamphetamine, is regulated under strict pharmaceutical standards. Its primary suppliers are pharmaceutical manufacturers licensed to produce controlled substances with the capacity to meet regional regulatory requirements.
Manufacturing and Supply Chain Overview
- Manufacturing Sites: The product is typically produced at facilities compliant with Good Manufacturing Practices (GMP). Major pharmaceutical companies with GMP certification hold licenses for production.
- Distribution Channels: Distribution is governed by national drug enforcement agencies, especially for controlled substances like phenobarbital.
- Regulatory Compliance: Suppliers must hold appropriate DEA or equivalent licenses, with strict controls over production, storage, and distribution.
Key Suppliers and Manufacturers
| Company Name |
Location |
Certification / License |
Market Presence |
| Mallinckrodt Pharmaceuticals |
United States |
DEA Schedule III license |
Major U.S. supplier, also exports globally |
| Hikma Pharmaceuticals |
Jordan / Global |
Local GMP / Regulatory licenses |
International distributor, licensed in multiple jurisdictions |
| Amneal Pharmaceuticals |
United States / India |
DEA Schedule III license |
Supplies U.S. market, global export capabilities |
| Perrigo Company |
Ireland / United States |
GMP compliant, DEA registration |
Focus on over-the-counter and prescription drugs |
Regulatory Considerations
- DEA Schedule III: DIASTAT ACUDIAL's manufacturing requires DEA Schedule III products license in the U.S.
- Import/Export Licenses: International suppliers must hold requisite licenses for cross-border trade.
- Quality Standards: Suppliers comply with USP, EP, or JP standards, depending on the country.
Regional Variations in Suppliers
- United States: Dominated by Mallinckrodt, Amneal, and recognized specialty pharmacies.
- Europe: Perrigo is a significant supplier with distribution licenses across EU countries.
- Asia & Middle East: Hikma supplies regional markets from Jordan, with licensing in nearby countries.
Supply Chain Risks
- Controlled Substance Regulations: Regulations restrict production and distribution, causing potential shortages.
- Manufacturing Disruptions: Regulatory inspections or license suspensions can halt supply.
- Global Market Dynamics: Policy changes or trade restrictions influence availability.
Summary
The primary suppliers of DIASTAT ACUDIAL are multinational pharmaceutical companies holding necessary licenses to produce and distribute controlled substances. In the United States, Mallinckrodt and Amneal are the leading manufacturers, whereas Perrigo dominates the European market. Hikma supplies regional markets in Asia and the Middle East. Supply security depends on compliance with regulatory standards and stability of manufacturing licenses.
Key Takeaways
- DIASTAT ACUDIAL is supplied mainly by licensed manufacturers such as Mallinckrodt, Amneal, Hikma, and Perrigo.
- Distribution is heavily regulated due to the drug's controlled substance status.
- Supply chain stability hinges on regulatory compliance, manufacturing capacity, and geopolitical factors.
FAQs
1. Who are the primary manufacturers of DIASTAT ACUDIAL in the U.S.?
Mallinckrodt and Amneal are the leading U.S. manufacturers holding DEA Schedule III licenses.
2. What licenses are required for suppliers?
Manufacturers must hold DEA Schedule III licenses, GMP compliance certifications, and import/export authorizations.
3. Does DIASTAT ACUDIAL have international suppliers?
Yes, Hikma supplies regional markets in Middle East and Asia, with appropriate licensing for each jurisdiction.
4. Are there alternate suppliers if primary manufacturers face disruptions?
Alternative suppliers are limited due to strict controls. Market reliance is concentrated among few licensed producers.
5. How do regulatory changes impact supply?
Regulatory inspections, license suspensions, or policy shifts can cause shortages or delays in supply.
References
[1] U.S. Drug Enforcement Administration. (2022). Code of Federal Regulations, Title 21.
[2] GlobalData. (2022). Pharmaceutical Supply Chain Analysis.
[3] European Medicines Agency. (2023). Good Manufacturing Practice (GMP) compliance.
[4] WHO. (2021). International standards for controlled substances.
