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Suppliers and packagers for NORITATE
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NORITATE
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 | NORITATE | metronidazole | CREAM;TOPICAL | 020743 | NDA | Bausch Health US, LLC | 0187-5202-60 | 1 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBE | 2013-08-09 |
| Bausch | NORITATE | metronidazole | CREAM;TOPICAL | 020743 | NDA | Oceanside Pharmaceuticals | 68682-202-60 | 60 g in 1 TUBE (68682-202-60) | 2023-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NORITATE
Introduction
NORITATE, a trademarked pharmaceutical product primarily referred to as methylphenidate hydrochloride, is a central nervous system stimulant used predominantly in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. As a Schedule II controlled substance due to its potential for abuse, the drug's supply chain involves highly regulated manufacturing and distribution channels. Understanding the suppliers of NORITATE, encompassing active pharmaceutical ingredient (API) manufacturers, finished dosage form (FDF) producers, and authorized distributors, is critical for stakeholders aiming for supply stability, regulatory compliance, and market positioning.
Manufacturers of Active Pharmaceutical Ingredient (API)
The core of NORITATE’s supply chain originates with API manufacturers specializing in methylphenidate hydrochloride. These manufacturers are responsible for producing high-quality, pharmacopeia-compliant active ingredients that meet stringent regulatory standards across different jurisdictions.
Key API Suppliers
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Novartis (Formerly Ciba-Geigy)
Historically, Novartis has been a prominent supplier of methylphenidate API, given the drug’s initial patent and development pipeline. Post-patent expiration, various generic manufacturers now have access to API production rights. -
Teva Pharmaceutical Industries Ltd.
A leading generic pharmaceutical manufacturer, Teva produces methylphenidate hydrochloride API and supplies to various finished dosage form manufacturers worldwide. Their compliance with Good Manufacturing Practice (GMP) standards positions them as a reliable source. -
Mallinckrodt Pharmaceuticals
Known for both branded and generic formulations, Mallinckrodt is a key methylphenidate API supplier, with a focus on manufacturing high-quality APIs compliant with global pharmacopoeias. -
ALMAC (Allergan's former API division)
Specialized in stimulant APIs, ALMAC has been involved in the synthesis of methylphenidate, although its current role is more niche. Many of its API production processes are now integrated into other pharmaceutical companies. -
Chinese and Indian API Manufacturers
India’s and China’s robust API manufacturing sectors have expanded considerably. Companies such as Zhejiang Huahai Pharmaceuticals (China), Dr. Reddy’s Laboratories (India), and Sun Pharmaceutical Industries (India) produce methylphenidate APIs adhering to international standards, often providing cost-effective sources.
API Quality & Regulatory Approvals
Quality standards such as GMP certification, US FDA approval, EMA compliance, and certification under the Pharmacopoeia (USP, EP) are critical. API suppliers must demonstrate successful regulatory audits to be considered reliable for NORITATE production—especially in markets like the US, Europe, and Japan.
Finished Dosage Form (FDF) Manufacturers
Final product manufacturing involves formulation, encapsulation or tablet compression, and packaging. Many companies hold approved ANDAs (Abbreviated New Drug Applications) or equivalent for methylphenidate-based products, including NORITATE.
Major Finished Dosage Suppliers
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Novartis Pharmaceuticals
As the original developer, Novartis initially produced NORITATE, although production might now be licensed or contracted to other manufacturers in certain markets. -
Teva Pharmaceuticals
Teva is one of the leading producers of methylphenidate-based products globally, including extended-release formulations. They supply both branded and generic equivalents to NORITATE, with markets ranging from the US to Europe and Australia. -
Mylan (now part of Viatris)
Mylan has an extensive portfolio of ADHD medications, including methylphenidate formulations. They serve as a significant supplier for markets requiring generic equivalents. -
Sun Pharmaceutical Industries
Sun Pharma manufactures methylphenidate formulations compliant with regulatory standards and supplies to multiple countries, often providing lower-cost options consistent with market demands. -
Lupin Ltd.
Indian pharmaceutical manufacturer Lupin produces methylphenidate formulations licensed for various markets, emphasizing affordability without compromising quality. -
Aurobindo Pharma
Aurobindo manufactures methylphenidate extended-release tablets, catering to regulated markets like the US and Europe.
Distribution & Contract Manufacturing
Many finished product manufacturers operate via Contract Manufacturing Organizations (CMOs), ensuring flexibility and scalability in supply. These CMOs often source APIs from multiple suppliers, emphasizing the importance of API quality and regulatory compliance to prevent supply disruptions.
Authorized Distributors and Supply Chain Dynamics
Due to NORITATE’s controlled substance classification, distribution channels are tightly regulated. Only authorized distributors with DEA licenses (in the US), EMA-approved channels (in Europe), or equivalent licenses can handle, distribute, or import the drug.
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Major Distributors in North America
- McKesson Corporation
- Cardinal Health
- AmerisourceBergen
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European Distributors
- Phoenix Group
- Alliance Healthcare
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Asia-Pacific Distributors
- Local licensed entities with restricted licenses for controlled substances.
These distributors work closely with manufacturers and regulatory agencies to ensure compliance, manage inventory, and prevent diversion.
Regulatory and Market Considerations
Because of the drug’s Schedule II status, any supplier involved in NORITATE’s supply chain must adhere to strict drug enforcement regulations and regular inspections. International suppliers must obtain necessary licenses and certificates of compliance, which may affect supply chain stability and pricing.
Emerging Trends and Future Outlook
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API Sourcing Diversification
Increasing reliance on rapid production and quality assurance has led to diversification of API sources, notably with emerging generic API manufacturers in India and China. -
Supply Chain Transparency
Enhanced traceability measures, such as serialization and blockchain, are being implemented to uphold integrity and compliance. -
Supply Chain Risks
Global manufacturing disruptions, regulatory compliance issues, and geopolitical factors could impact NORITATE supply chains, prompting stakeholders to develop mitigation strategies.
Key Takeaways
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API suppliers like Teva, Mallinckrodt, and emerging Indian and Chinese manufacturers are the backbone of NORITATE’s supply chain, emphasizing the importance of regulatory compliance and quality standards.
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Finished pharmaceutical manufacturers, including generics and established brand producers, largely depend on controlled APIs, often sourced from multiple approved suppliers to mitigate risks.
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Strict regulatory adherence is vital for all suppliers involved, due to NORITATE’s controlled substance classification, influencing sourcing, manufacturing, and distribution practices.
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Diversification and transparency in the supply chain are crucial in managing risks associated with disruptions, especially with geopolitical considerations affecting API manufacturing hubs.
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Market dynamics continue to evolve with increasing demand for cost-effective generics, prompting suppliers to innovate within regulatory frameworks without compromising compliance.
FAQs
1. Who are the leading API manufacturers for methylphenidate hydrochloride?
Prominent API suppliers include Teva Pharmaceutical Industries, Mallinckrodt Pharmaceuticals, and various Chinese and Indian manufacturers such as Zhejiang Huahai Pharmaceuticals and Dr. Reddy’s Laboratories.
2. Are there generic alternatives to NORITATE?
Yes, multiple generic formulations containing methylphenidate hydrochloride exist worldwide, produced by companies like Mylan, Sun Pharma, and Aurobindo Pharma, often under different trademarks.
3. How are supply chain risks for NORITATE managed?
Manufacturers diversify API sourcing, implement rigorous quality controls, and establish close regulatory oversight to mitigate risks of disruption. Supply chain monitoring and compliance audits are regularly conducted.
4. What regulatory agencies oversee NORITATE’s manufacturing and distribution?
In the US, the FDA regulates manufacturing and distribution. European markets are overseen by the EMA/EudraVigilance, while other regions rely on national agencies like PMDA in Japan or TGA in Australia.
5. Can the supply of NORITATE be affected by geopolitical events?
Yes. Political tensions, trade restrictions, or manufacturing shutdowns in key Asian manufacturing hubs can influence API availability and overall drug supply stability.
Sources
- U.S. Food and Drug Administration (FDA) – Drug Import and API Standards
- European Medicines Agency (EMA) – Active Substance Master File (ASMF) Database
- Pharmaceuticals Business Reports – API Manufacturers Directory
- Company Websites (Teva, Mylan, Sun Pharma, etc.) – Product portfolios and regulatory filings
- Industry analysis reports – Global API Supply Chain Trends
More… ↓
