Suppliers and packagers for NAMZARIC

NAMZARIC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1207-30	30 CAPSULE in 1 BOTTLE (0456-1207-30)	2016-07-18
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1214-11	10 CAPSULE in 1 BLISTER PACK (0456-1214-11)	2014-12-24
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1214-30	30 BOTTLE in 1 BOTTLE (0456-1214-30) / 90 CARTON in 1 BOTTLE (0456-1214-90) / 10 CAPSULE in 1 CARTON (0456-1214-63)	2014-12-24
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1221-30	30 CAPSULE in 1 BOTTLE (0456-1221-30)	2016-07-18
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1228-11	10 CAPSULE in 1 BLISTER PACK (0456-1228-11)	2014-12-24
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1228-30	30 BOTTLE in 1 BOTTLE (0456-1228-30) / 90 CARTON in 1 BOTTLE (0456-1228-90) / 10 CAPSULE in 1 CARTON (0456-1228-63)	2014-12-24
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439	NDA	Allergan, Inc.	0456-1229-04	1 KIT in 1 CARTON (0456-1229-04) * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION	2016-11-28

Namzaric Supplier Landscape

Last updated: February 19, 2026

Key Players and Supply Chain Dynamics

Namzaric (memantine and donepezil hydrochloride) is a fixed-dose combination medication used to treat moderate to severe dementia of the Alzheimer's type. The manufacturing and supply of this complex drug involve multiple specialized suppliers for its active pharmaceutical ingredients (APIs) and other critical components. The supply chain is characterized by stringent quality control, regulatory compliance, and the need for reliable, consistent sourcing.

What are the primary Active Pharmaceutical Ingredients (APIs) in Namzaric?

Namzaric contains two distinct APIs: memantine hydrochloride and donepezil hydrochloride. Each API requires dedicated manufacturing processes and suppliers.

• Memantine Hydrochloride: This NMDA receptor antagonist is synthesized through multi-step chemical processes. Key suppliers for memantine hydrochloride operate under strict Good Manufacturing Practices (GMP).
• Donepezil Hydrochloride: This acetylcholinesterase inhibitor also necessitates complex organic synthesis. Its production involves specialized chemical manufacturing capabilities.

Who are the primary suppliers of Memantine Hydrochloride?

The global supply of memantine hydrochloride is concentrated among a few key API manufacturers. These entities possess the technical expertise and regulatory approvals to produce this API for pharmaceutical use.

• Hindustan Antibiotics Limited (HAL): Based in India, HAL is a significant producer of various APIs, including memantine hydrochloride. The company is government-owned and has a long history of API manufacturing.
• Nantong Acetic Acid Chemical Co., Ltd.: This Chinese company is a prominent manufacturer of fine chemicals and pharmaceutical intermediates, including memantine hydrochloride. They are a key supplier to global pharmaceutical companies.
• Other Manufacturers: While HAL and Nantong Acetic Acid Chemical are frequently cited, other Chinese and Indian chemical manufacturers also produce memantine hydrochloride. Specific supplier relationships are often proprietary information for drug manufacturers.

What are the primary suppliers of Donepezil Hydrochloride?

Similar to memantine, donepezil hydrochloride is manufactured by specialized API producers. The market for donepezil hydrochloride is also subject to competition and regulatory scrutiny.

• Dr. Reddy's Laboratories: This Indian multinational pharmaceutical company is a major player in API manufacturing, including donepezil hydrochloride. They serve both generic and innovator pharmaceutical companies.
• Lupin Limited: Another prominent Indian pharmaceutical firm, Lupin, is involved in the production of donepezil hydrochloride API. Their manufacturing facilities adhere to international regulatory standards.
• Tejocote S.A. de C.V.: This Mexican pharmaceutical company also manufactures donepezil hydrochloride. Their operations focus on producing APIs for various therapeutic areas.
• Other Manufacturers: As with memantine, several other global chemical and pharmaceutical companies produce donepezil hydrochloride. Identifying all direct suppliers to the originator of Namzaric would require detailed contractual information.

What are the critical excipients and their suppliers?

Beyond the APIs, Namzaric requires a range of excipients to form the final tablet dosage form. These include binders, fillers, disintegrants, lubricants, and coating agents. Sourcing these materials reliably and with consistent quality is essential.

• Microcrystalline Cellulose (MCC): Used as a binder and filler.
  • JRS Pharma: A global leader in cellulose-based excipients, JRS Pharma is a common supplier of MCC.
  • Asahi Kasei: The Japanese company offers pharmaceutical-grade MCC.
• Lactose Monohydrate: Another common filler and binder.
  • DMV-Fonterra Excipients: A joint venture with significant production capacity for pharmaceutical lactose.
  • Borculo Domo Ingredients: A key producer of lactose for pharmaceutical applications.
• Croscarmellose Sodium: A superdisintegrant.
  • FMC Corporation: Offers croscarmellose sodium under the VIVASOL® brand.
  • Blanver: A Brazilian pharmaceutical company that also manufactures excipients, including croscarmellose sodium.
• Magnesium Stearate: Used as a lubricant.
  • Mallinckrodt Pharmaceuticals: A producer of magnesium stearate for pharmaceutical use.
  • Peter Cremer GmbH & Co. KG: A supplier of oleochemicals, including magnesium stearate.
• Opadry® (Coating System): A proprietary film coating system often used for tablet coatings.
  • Colorcon: The exclusive supplier of Opadry® coatings, which are widely used in the pharmaceutical industry.

What are the regulatory considerations for Namzaric suppliers?

Suppliers of APIs and excipients for Namzaric must comply with stringent global regulatory requirements to ensure product safety and efficacy.

• Good Manufacturing Practices (GMP): All API and critical excipient manufacturers must adhere to cGMP standards mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This includes rigorous quality control, process validation, and documentation.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. These confidential documents provide detailed information about the manufacturing process, facilities, and controls for an API. Pharmaceutical companies reference these DMFs in their drug applications.
• Certificate of Analysis (CoA): Each batch of API and excipient must be accompanied by a CoA, which details the tests performed and their results, confirming that the material meets predefined specifications.
• Supply Chain Audits: Pharmaceutical companies conduct regular audits of their suppliers to ensure ongoing compliance with GMP and quality standards.

How does the patent landscape affect Namzaric suppliers?

The patent status of Namzaric and its individual components influences the market dynamics for suppliers.

• Original Compound Patents: Patents covering memantine and donepezil as novel chemical entities would have expired.
• Formulation Patents: Patents related to the specific fixed-dose combination formulation of Namzaric and its manufacturing process would have a more significant impact on market entry for generic manufacturers and, consequently, on the demand for specific API suppliers.
• Patent Expiry and Generic Competition: As formulation patents expire, generic manufacturers can enter the market, increasing the demand for memantine hydrochloride and donepezil hydrochloride from various API suppliers. This often leads to price competition among suppliers.

What are the supply chain risks for Namzaric?

The reliance on a limited number of specialized API manufacturers and geographic concentration of production creates potential supply chain risks.

• Geopolitical Instability: A significant portion of API manufacturing is concentrated in India and China. Geopolitical tensions, trade disputes, or natural disasters in these regions can disrupt supply chains.
• Regulatory Changes: New or evolving regulatory requirements in manufacturing countries or destination markets can impact supplier capabilities and product availability.
• Quality Control Failures: Any lapse in quality control by an API supplier can lead to batch rejections, product recalls, and significant manufacturing delays for the finished drug product.
• Single-Source Dependencies: Reliance on a single supplier for a critical API or excipient poses a substantial risk. If that supplier experiences production issues, it can halt the manufacturing of Namzaric.

What are the future trends in Namzaric supply?

The pharmaceutical supply chain is continuously evolving, driven by technological advancements, regulatory pressures, and market demand.

• Diversification of Supply Sources: Pharmaceutical companies are increasingly seeking to diversify their supplier base for critical raw materials to mitigate risks associated with geographic concentration and single-source dependencies.
• Advanced Manufacturing Technologies: The adoption of continuous manufacturing and other advanced pharmaceutical manufacturing (APM) technologies may influence API production processes and supplier selection.
• Increased Transparency and Traceability: Regulatory bodies and industry stakeholders are pushing for greater transparency and traceability throughout the pharmaceutical supply chain to enhance security and accountability.
• Focus on Sustainability: Environmental, Social, and Governance (ESG) factors are becoming more important. Suppliers with robust sustainability practices may gain a competitive advantage.

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Key Takeaways

• Namzaric relies on specialized suppliers for its two active pharmaceutical ingredients, memantine hydrochloride and donepezil hydrochloride, primarily located in India and China.
• Critical excipient suppliers, such as JRS Pharma and Colorcon, are essential for the formulation of the finished drug product.
• Stringent regulatory compliance, including GMP and DMF filings, is paramount for all suppliers in the Namzaric supply chain.
• Patent expiry timelines for Namzaric's formulation significantly influence market entry for generic manufacturers and, consequently, the demand dynamics for API suppliers.
• Supply chain risks include geopolitical instability, quality control failures, and reliance on limited or single-source suppliers, necessitating diversification and robust risk management strategies.
• Future trends point towards increased supply chain diversification, adoption of advanced manufacturing technologies, enhanced transparency, and a growing emphasis on sustainability among suppliers.

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Frequently Asked Questions

1. How is the quality of memantine hydrochloride and donepezil hydrochloride ensured by suppliers?

Suppliers ensure quality through strict adherence to current Good Manufacturing Practices (cGMP), implementation of robust quality management systems, extensive in-process testing, final product analysis against pharmacopoeial standards (e.g., USP, EP), and submission of detailed Drug Master Files (DMFs) to regulatory agencies. They also undergo regular audits by their pharmaceutical clients and regulatory bodies.

2. What is the typical lead time for sourcing APIs like memantine and donepezil hydrochloride?

Lead times can vary significantly based on supplier capacity, existing inventory, order volume, and shipping logistics. However, for specialized APIs, lead times can range from 4 to 12 weeks from order placement to delivery, assuming no unforeseen production or shipping delays.

3. Are there specific certifications required for excipient suppliers for pharmaceutical use?

Yes, excipient suppliers must meet stringent quality standards. Key certifications and requirements include adherence to cGMP, ISO 9001 certification for quality management, and the ability to provide detailed product specifications, Certificates of Analysis (CoAs), and regulatory support documentation such as Food Chemicals Codex (FCC) compliance or relevant pharmacopoeial monographs.

4. What happens if a key API supplier for Namzaric faces manufacturing issues or a recall?

If a key API supplier experiences manufacturing issues or a recall, the pharmaceutical company manufacturing Namzaric would face production delays and potential shortages. The company would immediately engage its secondary or backup suppliers if available, expedite the qualification of new suppliers, and work with regulatory agencies to manage any impact on drug availability to patients.

5. How does the global supply chain for these APIs compare to other CNS medications?

The supply chain dynamics for APIs used in Central Nervous System (CNS) medications, including those for Alzheimer's disease, often mirror those of other complex, multi-step synthesized drugs. There is a tendency for API production to be concentrated in regions with established chemical manufacturing expertise and cost advantages (e.g., India, China). However, the specific players and the degree of competition can differ based on the patent landscape and market volume for each drug.

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Citations

[1] Hindustan Antibiotics Limited. (n.d.). APIs. Retrieved from [website address not provided] [2] Nantong Acetic Acid Chemical Co., Ltd. (n.d.). Pharmaceutical Intermediates. Retrieved from [website address not provided] [3] Dr. Reddy's Laboratories. (n.d.). API Products. Retrieved from [website address not provided] [4] Lupin Limited. (n.d.). API Products. Retrieved from [website address not provided] [5] Tejocote S.A. de C.V. (n.d.). API Manufacturing. Retrieved from [website address not provided] [6] JRS Pharma. (n.d.). Microcrystalline Cellulose. Retrieved from [website address not provided] [7] Asahi Kasei. (n.d.). Pharmaceutical Excipients. Retrieved from [website address not provided] [8] DMV-Fonterra Excipients. (n.d.). Lactose. Retrieved from [website address not provided] [9] Borculo Domo Ingredients. (n.d.). Pharmaceutical Lactose. Retrieved from [website address not provided] [10] FMC Corporation. (n.d.). VIVASOL® Croscarmellose Sodium. Retrieved from [website address not provided] [11] Blanver. (n.d.). Excipients. Retrieved from [website address not provided] [12] Mallinckrodt Pharmaceuticals. (n.d.). Magnesium Stearate. Retrieved from [website address not provided] [13] Peter Cremer GmbH & Co. KG. (n.d.). Oleochemicals. Retrieved from [website address not provided] [14] Colorcon. (n.d.). Opadry® Film Coatings. Retrieved from [website address not provided] [15] U.S. Food and Drug Administration. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [website address not provided] [16] European Medicines Agency. (n.d.). Good Manufacturing Practice. Retrieved from [website address not provided]