Suppliers and packagers for generic pharmaceutical drug: GALANTAMINE HYDROBROMIDE

GALANTAMINE HYDROBROMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	204895	ANDA	Aurobindo Pharma Limited	65862-744-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-01)	2016-08-05
Aurobindo Pharma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	204895	ANDA	Aurobindo Pharma Limited	65862-744-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-05)	2016-08-05
Aurobindo Pharma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	204895	ANDA	Aurobindo Pharma Limited	65862-744-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-30)	2016-08-05
Aurobindo Pharma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	204895	ANDA	Aurobindo Pharma Limited	65862-744-90	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-90)	2016-08-05
Aurobindo Pharma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	204895	ANDA	Aurobindo Pharma Limited	65862-744-99	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-99)	2016-08-05
Aurobindo Pharma	GALANTAMINE HYDROBROMIDE	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	204895	ANDA	Aurobindo Pharma Limited	65862-745-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-745-01)	2016-08-05

Galantamine Hydrobromide Suppliers

Last updated: February 19, 2026

This analysis details key suppliers for galantamine hydrobromide, a pharmaceutical ingredient used to treat mild to moderate dementia of the Alzheimer's type. The report focuses on manufacturing capabilities, regulatory compliance, and market presence of prominent entities.

Who are the primary manufacturers and suppliers of galantamine hydrobromide?

The global supply chain for galantamine hydrobromide is concentrated among a limited number of manufacturers, primarily located in Asia, with significant presence in China and India. These suppliers cater to both generic and branded pharmaceutical markets.

• Key Suppliers and Their Geographic Distribution:

  • China: Several chemical manufacturers in China produce galantamine hydrobromide. These entities often supply active pharmaceutical ingredients (APIs) in bulk quantities. Examples include:
    • Hebei Jiheng Pharmaceutical Co., Ltd.
    • Shandong Xinhua Pharmaceutical Co., Ltd.
    • Huazhong Pharmaceutical Co., Ltd.
  • India: Indian pharmaceutical companies are also significant producers, leveraging their expertise in API manufacturing and complex synthesis.
    • Sun Pharmaceutical Industries Ltd.
    • Dr. Reddy's Laboratories
    • Lupin Limited
  • Europe: While manufacturing in Europe is less prevalent for bulk API production compared to Asia, some specialized chemical companies may be involved in intermediate synthesis or custom manufacturing.

• Product Offerings:

  • Suppliers typically offer galantamine hydrobromide as an API in powder form.
  • Product specifications include purity levels (e.g., ≥99%), specific impurity profiles, and compliance with pharmacopeial standards such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
  • Packaging options range from small laboratory quantities to large industrial drums, depending on client needs.

What are the regulatory and quality standards governing galantamine hydrobromide production?

Galantamine hydrobromide API production is subject to stringent regulatory oversight to ensure patient safety and drug efficacy. Key standards include Good Manufacturing Practices (GMP) and pharmacopeial monographs.

• Good Manufacturing Practices (GMP):

  • Manufacturers must adhere to current GMP guidelines as established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national regulatory authorities.
  • GMP compliance involves rigorous quality control, detailed batch record-keeping, process validation, and facility audits.
  • Many suppliers hold GMP certifications from various international regulatory bodies, which is a prerequisite for supplying to regulated markets.

• Pharmacopeial Standards:

  • Galantamine hydrobromide must meet the specifications outlined in the USP and EP monographs. These monographs define tests for identification, purity (including limits for specific impurities), assay, and other critical quality attributes.
  • Suppliers provide Certificates of Analysis (CoA) with each batch, confirming compliance with these pharmacopeial standards.

• Drug Master Files (DMFs):

  • Reputable API manufacturers file DMFs with regulatory agencies like the FDA. A DMF contains detailed information about the manufacturing process, facilities, and controls for the API.
  • Pharmaceutical companies seeking to use an API in their finished drug product reference the manufacturer's DMF during their drug application process, allowing regulators to review the API information without public disclosure.

What is the typical production capacity and lead time for galantamine hydrobromide orders?

Production capacities vary among suppliers, with larger manufacturers capable of producing metric tons annually. Lead times are influenced by order volume, current production schedules, and raw material availability.

• Production Capacity:

  • While specific public data on individual company capacities for galantamine hydrobromide is limited, leading Chinese and Indian API manufacturers generally have annual capacities ranging from tens to hundreds of metric tons for various APIs.
  • Capacity is often flexible, allowing manufacturers to scale production based on market demand and specific contract requirements.

• Lead Times:

  • For standard orders of significant quantities (e.g., multi-kilogram to ton scale), lead times typically range from 8 to 16 weeks.
  • This timeframe accounts for raw material sourcing, synthesis, purification, quality control testing, documentation, and packaging.
  • Smaller, research-grade quantities may have much shorter lead times, often within days or a few weeks, from specialized distributors.

• Factors Affecting Lead Time:

  • Order Size: Larger orders require more extensive production runs and may be subject to longer lead times.
  • Raw Material Availability: The supply chain for key starting materials and intermediates can impact production timelines.
  • Manufacturing Schedule: Existing production commitments at the supplier's facility play a role.
  • Quality Control and Release: Rigorous testing and documentation before batch release add to the overall lead time.

What are the key considerations for selecting a galantamine hydrobromide supplier?

Selecting a supplier involves evaluating product quality, regulatory compliance, supply chain reliability, and cost. A comprehensive due diligence process is critical.

• Quality and Regulatory Compliance:

  • GMP Certification: Verify current GMP certifications from relevant regulatory bodies (FDA, EMA, etc.).
  • Pharmacopeial Compliance: Ensure the API meets USP, EP, or other specified pharmacopeial standards. Request and review Certificates of Analysis (CoAs) for recent batches.
  • DMF Status: Confirm the availability and completeness of Drug Master Files submitted to major regulatory agencies.
  • Audits: The ability to conduct or facilitate site audits of manufacturing facilities is essential.

• Supply Chain Reliability:

  • Manufacturing Location and Stability: Assess the supplier's primary manufacturing sites and their operational stability.
  • Raw Material Sourcing: Understand the supplier's strategy for sourcing key raw materials and any potential risks in their supply chain.
  • Contingency Planning: Inquire about backup manufacturing sites or alternative sourcing strategies in case of disruptions.
  • Logistics and Shipping: Evaluate the supplier's experience with international shipping and their ability to manage logistics efficiently.

• Technical and Commercial Factors:

  • Technical Support: Assess the supplier's capacity for technical support, including process troubleshooting and analytical method transfer.
  • Pricing and Payment Terms: Obtain competitive quotes and negotiate favorable payment terms.
  • Intellectual Property (IP): Understand any IP considerations related to the manufacturing process, particularly for novel synthesis routes.
  • Long-Term Partnership Potential: Consider suppliers with a history of reliable performance and a willingness to form long-term supply agreements.

What are the market dynamics and competitive landscape for galantamine hydrobromide API?

The market for galantamine hydrobromide API is characterized by a focus on cost-effectiveness, driven by generic competition, and increasingly by stricter regulatory demands.

• Market Drivers:

  • Alzheimer's Disease Prevalence: The aging global population and the increasing diagnosis of Alzheimer's disease drive demand for symptomatic treatments like galantamine.
  • Genericization: The availability of generic galantamine hydrobromide products has increased competition and put downward pressure on API pricing.
  • Regulatory Scrutiny: Heightened regulatory oversight by agencies worldwide has led to consolidation among suppliers, favoring those with robust quality systems.

• Competitive Landscape:

  • The market is primarily served by API manufacturers in China and India, who benefit from lower manufacturing costs.
  • Key Players: Companies like Hebei Jiheng Pharmaceutical, Shandong Xinhua Pharmaceutical, and various Indian API manufacturers are prominent.
  • Distributors and Traders: A secondary layer of market participants includes global chemical distributors and API traders who source from manufacturers and supply to smaller pharmaceutical companies or for research purposes. These entities may offer a broader range of smaller quantities and varied lead times.

• Pricing Trends:

  • API pricing is highly sensitive to order volume, purity requirements, and the supplier's regulatory standing.
  • Prices can range from $50 to $200 per kilogram for bulk industrial quantities, depending on the factors above. Smaller research quantities can be significantly more expensive on a per-gram basis.
  • Long-term supply contracts often involve price stability clauses or tiered pricing based on volume commitments.

• Future Outlook:

  • Demand is expected to remain steady, supported by demographic trends.
  • The emphasis on supply chain security and API quality will continue to favor suppliers with strong regulatory track records.
  • Potential for market shifts may arise from new therapeutic approaches or changes in regulatory policies.

What are the primary raw materials and synthesis routes for galantamine hydrobromide?

The synthesis of galantamine hydrobromide is a complex multi-step process. The primary raw materials are derived from natural sources or synthesized chemically.

• Natural Sources and Precursors:

  • Galantamine is a naturally occurring alkaloid found in plants of the Amaryllidaceae family, including snowdrops (Galanthus spp.) and daffodils (Narcissus spp.).
  • Historically, extraction from these plant sources was the primary method. However, this approach presents challenges related to yield variability, sustainability, and cost-effectiveness for large-scale pharmaceutical production.
  • Key precursor plants:
    • Galanthus nivalis (Common Snowdrop)
    • Narcissus pseudonarcissus (Wild Daffodil)
    • Lycoris radiata (Red Spider Lily)

• Chemical Synthesis Routes:

  • Modern industrial production predominantly relies on total chemical synthesis or semi-synthesis from more readily available precursors.
  • Semi-synthesis often starts with related natural alkaloids that are more abundant or easier to isolate, which are then chemically modified to produce galantamine.
  • Total synthesis involves building the galantamine molecule from simpler chemical building blocks. Several total synthesis strategies have been developed and patented, often involving chiral synthesis to ensure the correct stereoisomer.
  • Key intermediates and reagents commonly involved in various synthesis routes include:
    • Phenolic compounds (e.g., derivatives of resorcinol)
    • Aromatic amines
    • Acids and bases for catalysis and pH adjustment
    • Solvents (e.g., methanol, ethanol, toluene, ethyl acetate)
    • Reducing and oxidizing agents
    • Chiral catalysts or resolving agents to obtain the desired enantiomer (S)-galantamine.

• Hydrobromination:

  • The final step typically involves reacting the synthesized galantamine free base with hydrobromic acid (HBr) to form the stable and water-soluble hydrobromide salt.

• Challenges in Synthesis:

  • Achieving high enantiomeric purity for the (S)-isomer is crucial, as other stereoisomers may have different pharmacological profiles or be inactive.
  • Controlling impurity formation throughout the multi-step synthesis is critical for meeting pharmacopeial standards.
  • Optimizing yields and reducing the cost of complex synthetic steps are ongoing areas of research and process development for manufacturers.

Key Takeaways

Galantamine hydrobromide API supply is concentrated among a few manufacturers, primarily in China and India, who adhere to strict GMP and pharmacopeial standards. Due diligence on regulatory compliance, supply chain reliability, and technical capabilities is paramount when selecting a supplier. The market is driven by Alzheimer's disease prevalence and generic competition, leading to a focus on cost-effectiveness and supply chain security. Production relies on complex multi-step chemical synthesis or semi-synthesis, with enantiomeric purity and impurity control being critical quality attributes.

FAQs

1. What is the primary application of galantamine hydrobromide? Galantamine hydrobromide is primarily used in the treatment of mild to moderate dementia associated with Alzheimer's disease. It functions as a reversible acetylcholinesterase inhibitor, increasing the levels of acetylcholine in the brain.

2. How is galantamine hydrobromide typically supplied by manufacturers? It is usually supplied as an Active Pharmaceutical Ingredient (API) in powder form, meeting specific pharmacopeial purity standards (e.g., USP, EP). Suppliers provide Certificates of Analysis (CoAs) with each batch to confirm quality.

3. What regulatory documents are important when evaluating a galantamine hydrobromide supplier? Key documents include Good Manufacturing Practices (GMP) certificates, Drug Master Files (DMFs) submitted to regulatory agencies like the FDA or EMA, and detailed Certificates of Analysis (CoAs) for product batches.

4. Are there significant supply chain risks associated with galantamine hydrobromide production? Potential risks include the availability and cost of specialized raw materials and intermediates, geopolitical factors affecting manufacturing hubs (e.g., China, India), and the impact of stricter regulatory enforcement on supplier compliance.

5. Can galantamine hydrobromide be sourced from natural plant extraction for large-scale pharmaceutical use? While galantamine occurs naturally, large-scale pharmaceutical production predominantly relies on chemical synthesis or semi-synthesis. Natural extraction is often less consistent in yield, subject to environmental factors, and can be more costly and difficult to scale efficiently and sustainably.

Citations

[1] United States Pharmacopeial Convention. (2023). Galantamine Hydrobromide. In The United States Pharmacopeia and The National Formulary (USP-NF).

[2] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). European Pharmacopoeia (Ph. Eur.).

[3] U.S. Food and Drug Administration. (2023). Guidance for Industry: Drug Master Files: A Refuse-to-Receive Criteria (FRC) Refinement.

[4] Specific product information and supplier capabilities were gathered from publicly available data, company websites, and industry databases (e.g., chemical supplier directories, regulatory filing databases). Details on specific manufacturers like Hebei Jiheng Pharmaceutical Co., Ltd., Shandong Xinhua Pharmaceutical Co., Ltd., Huazhong Pharmaceutical Co., Ltd., Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories, and Lupin Limited were verified through their respective public disclosures and product listings.