Suppliers and packagers for generic pharmaceutical drug: AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944	NDA	Supernus Pharmaceuticals	17772-085-21	21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21)	2017-08-24
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944	NDA	Supernus Pharmaceuticals	17772-085-60	60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60)	2017-08-24
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944	NDA	Supernus Pharmaceuticals	17772-170-21	21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-21)	2017-08-24

Amantadine Hydrochloride Suppliers: Who Makes It, What Forms Are Common, and How to Shortlist Vendors

Last updated: May 25, 2026

Amantadine hydrochloride is manufactured and supplied globally across multiple dosage forms (oral solids and injectable), with a supply chain that typically includes API producers and finished-dose manufacturers that supply distributors, wholesalers, and contract manufacturing organizations. This landscape is driven by whether buyers need USP-grade API, drug-product units for FDA/US distribution, or reagent-like bulk for non-US markets.

Which companies supply amantadine hydrochloride API?

Featured answer: Amantadine hydrochloride API is supplied by a mix of Chinese and Indian API manufacturers and specialty European players that also support US and EU market filings through DMFs, CEPs, and commercial supply agreements.

API grade, DMF readiness, and typical supplier behavior

In practice, procurement teams usually separate suppliers by:

• DMF/EDMF status for US submissions
• COA and impurity profile alignment to the target pharmacopeia specification (USP/BP/EP)
• Ability to supply both bulk drug substance and intermediate salts/crude salts used for purification

How to source the right amantadine hydrochloride API

Shortlisting usually targets vendors with:

• Verified impurity limits for amantadine hydrochloride (including known route impurities such as related amines)
• Consistent particle-size and bulk density specs if the buyer uses direct compression or capsulation processes
• Export packaging aligned to qualification lots (typically drum/IBC with batch traceability)

Who supplies amantadine hydrochloride finished dosage forms (tablets/capsules/solutions)?

Featured answer: Finished-dose amantadine hydrochloride products are supplied via generic manufacturers and specialty pharma that contract through wholesalers and distributors, with inventory and pricing frequently shaped by US generic competition and secondary markets.

Common finished-dose use cases

• Bulk purchase by distributors for hospital neurology and infectious disease formularies
• Generic replenishment programs by wholesalers
• Contract manufacturing for labelers that hold product permissions and product-specific packaging requirements

Dosage forms buyers typically request

• Oral immediate-release tablets or capsules
• Oral solutions (where available)
• Injectable solutions (where available, typically for specific hospital use cases)

What dosage forms drive amantadine hydrochloride supplier selection?

Featured answer: Supplier selection depends on whether the buyer needs GMP oral solid drug product, GMP sterile injectable, or non-sterile API, because qualification and release testing requirements differ materially.

Oral solids: tablets and capsules

Procurement screening emphasizes:

• Bio-burden controls for oral production
• Uniformity of content and dissolution specification package
• Packaging format (bottles/blisters) and barcoding

Solutions and injectables

Procurement screening emphasizes:

• Sterility assurance for injectable presentations
• Container closure integrity and leachables/extractables control
• Heat and hold-time robustness for solution manufacturing

What patents protect amantadine hydrochloride and how does that affect suppliers?

Featured answer: Amantadine hydrochloride is an established generic active, and supplier availability is primarily constrained by manufacturing capacity and regulatory status rather than active US product exclusivity.

Patent estate impact on supplier entry

• Early entrant filings and process patents historically shaped capacity, but today supplier entry is mostly governed by:
  • Current GMP capability
  • DMF/ANDA/505(b)(2) linkages for finished dosage
  • Market demand cycles and inventory economics

What is the FDA/Orange Book status of amantadine hydrochloride products?

Featured answer: US marketed products for amantadine hydrochloride generally fall under generic competition, so the Orange Book typically shows multiple approved applications rather than a single long exclusivity anchor.

How that status shapes supply

• Multiple ANDAs for dosage forms usually reduce the risk of single-supplier lock-in
• Periodic shortages track batch availability and inspection outcomes rather than patent barriers

When do amantadine hydrochloride products lose exclusivity?

Featured answer: For established generic amantadine hydrochloride products, patent/exclusivity timing is usually not the gating factor for supply; most products are already past exclusivity.

Procurement implication

Supply risk is dominated by:

• API batch acceptance and impurity drift
• Sterile capacity for injectable SKUs, if applicable
• Wholesale distribution dynamics and contracting

What generic entry risks exist for amantadine hydrochloride?

Featured answer: Generic entry risk for amantadine hydrochloride is limited by commercial saturation, but manufacturing-quality and regulatory inspection outcomes are practical bottlenecks that can temporarily constrain supply.

Where new entrants get blocked

• Inability to meet impurity profile or dissolution release specs
• Failure to maintain GMP compliance during scale-up
• Documentation gaps for DMF-to-product consistency

Which supplier types are best for different buyer objectives?

API buyers

Best-fit suppliers:

• DMF-supported API manufacturers with consistent impurity control
• Vendors that can provide stability data and compendial compliance packages

Drug-product buyers

Best-fit suppliers:

• Finished-dose generic manufacturers with validated packaging and labeling
• Contract manufacturers that can run the buyer’s packaging spec and line clearance strategy

Hospital/wholesaler buyers

Best-fit suppliers:

• US distribution networks with inventory and lead-time reliability
• Manufacturers with a history of uninterrupted supply during batch-risk windows

How does amantadine hydrochloride supply chain typically map from API to drug product?

Featured answer: The supply chain generally runs from API production to drug-product manufacturing, then to wholesalers/distributors, with regulatory filings and batch release acting as the critical control points.

Typical handoffs

1. API synthesis and crystallization
2. API testing and COA release for qualification lots
3. Formulation and blending (oral) or sterile compounding/filtration/filled product (injectable)
4. Finished product testing (potency, uniformity, dissolution/sterility)
5. Labeling, packaging, and distribution

What manufacturing/IP barriers affect supply for amantadine hydrochloride?

Featured answer: IP barriers are usually secondary for an established generic; manufacturing and compliance barriers dominate.

Practical barriers

• Scale-up reproducibility for crystallization and impurity removal
• Control of hygroscopicity and stability during storage and distribution
• Quality agreement readiness across sites (audits, CAPA history)

How to shortlist amantadine hydrochloride suppliers for R&D, tech transfer, or procurement

Featured answer: Shortlisting should be built around compliance and documentation capability first, then capacity and reliability.

Vendor diligence checklist

• GMP certificate and recent inspection history (site-level)
• DMF documentation alignment for API (where applicable)
• Batch record traceability and change control discipline
• Stability package and analytical method transfer readiness
• Ability to supply qualifying lots on a defined cadence

Key Takeaways

• Amantadine hydrochloride is supplied through both API producers and finished-dose manufacturers, with selection driven by dosage form needs and regulatory documentation readiness.
• For an established generic API, patent/exclusivity is typically not the main constraint on supply.
• Practical barriers center on impurity control, GMP compliance, stability, and (for injectables) sterile manufacturing capacity.
• Supplier shortlisting should prioritize DMF/quality documentation, release test alignment, and proven batch-to-batch consistency.

FAQs

1. Which vendors can supply US-ready amantadine hydrochloride API with DMF support?
2. Do amantadine hydrochloride tablets and capsules use different supplier qualification criteria than injectable solutions?
3. What specifications matter most when switching amantadine hydrochloride API suppliers?
4. How do impurity profiles typically affect lot acceptance for amantadine hydrochloride drug substance?
5. What lead-time risks most often drive shortages of amantadine hydrochloride finished dosage forms?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA Drug Shortages. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm