AMOXICILLIN: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	065271	ANDA	NorthStar Rx LLC	16714-298-01	100 CAPSULE in 1 BOTTLE (16714-298-01)	2005-11-09
Aurobindo	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	065271	ANDA	NorthStar Rx LLC	16714-298-02	500 CAPSULE in 1 BOTTLE (16714-298-02)	2005-11-09
Aurobindo	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	065271	ANDA	NorthStar Rx LLC	16714-299-01	30 CAPSULE in 1 BOTTLE (16714-299-01)	2005-11-09
Aurobindo	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	065271	ANDA	NorthStar Rx LLC	16714-299-02	50 CAPSULE in 1 BOTTLE (16714-299-02)	2005-11-09
Aurobindo	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	065271	ANDA	NorthStar Rx LLC	16714-299-03	100 CAPSULE in 1 BOTTLE (16714-299-03)	2005-11-09
Aurobindo	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	065271	ANDA	NorthStar Rx LLC	16714-299-04	500 CAPSULE in 1 BOTTLE (16714-299-04)	2005-11-09
Aurobindo	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	065271	ANDA	QPharma Inc	42708-076-30	30 CAPSULE in 1 BOTTLE (42708-076-30)	2005-11-09
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 23, 2026

Amoxicillin Suppliers: What Companies Manufacture Active Ingredient, Dosage Forms, and Contract Packaging

Executive summary: Amoxicillin supply chains split into three tiers: (1) active pharmaceutical ingredient (API) producers of amoxicillin (and often intermediates), (2) branded and generic formulators making tablets, capsules, and suspensions, and (3) distribution and contract manufacturing organizations (CMOs) that package, label, and supply finished dosage forms. In the U.S., “suppliers” that matter for sourcing and risk analysis are the FDA-listed manufacturers for each National Drug Code (NDC) and their registered API/finished-dose sites in FDA’s Drug Establishment Registration and Listing System (DERL).

Who are the amoxicillin API manufacturers and ingredient suppliers?

Answer: The practical set of suppliers is defined by FDA DERL registrations for amoxicillin API manufacturing sites and the listed finished-dose manufacturers that source amoxicillin API for specific NDCs.

API supplier categories

Amoxicillin API makers
Companies registered to manufacture amoxicillin as an API, typically via fermentation or chemical processing routes through penicillin intermediates.
Intermediate suppliers that feed API producers
Amoxicillin production often depends on upstream penicillin intermediates; these suppliers can be critical in shortage events even if they are not the final API label holder.
Finished-dose suppliers that control API procurement
Finished-dose manufacturers (tablets, capsules, suspensions) may source from multiple API producers and qualify those sources under GMP change control.

How to identify the supplier list that matters

For business decisions (sourcing, litigation risk, or continuity planning), rely on:

FDA DERL listing for the specific amoxicillin dosage form manufacturer and its drug substance handling registrations.
FDA Orange Book and NDC labeling for which companies manufacture each strength and dosage form.

Source: FDA DERL (Drug Establishment Registration and Listing) is the authoritative registry for facility registrations. (See references list.)

Which companies supply amoxicillin tablets, capsules, and oral suspensions in the US market?

Answer: The companies that supply each product are the firms listed as manufacturers on the NDC label for that product’s strength and dosage form, supported by DERL site registrations.

Common amoxicillin dosage forms and supplier footprints

Tablets (immediate-release)
Capsules (immediate-release)
Oral suspension powders and ready-to-use liquids
Pediatric dosing strengths (which often drive different labeling and labeling suppliers)

Supply risk drivers by dosage form

Suspensions require specific excipient systems and container-closure qualification.
Taste masking and stability can narrow qualified manufacturing lines.
Distribution differs for cold-chain requirements (amoxicillin oral suspensions generally do not require cold chain, but container/label configuration still matters for shelf life).

Source: FDA DERL and NDC labeling identify the manufacturing entities tied to each dosage form.

What contract manufacturers and CDMOs make amoxicillin finished drugs?

Answer: CDMOs supply finished-dose capability under contract to brand owners and generic companies. The supplier set that matters is the CDMO listed as the finished-dose manufacturer on the NDC label for each product strength and package.

What CDMO relationships look like in practice

Packaging and labeling work: unit-dose bottling, blister packaging, and case packing.
Finished-dose GMP manufacturing: formulation, granulation, filling, and sterilization (for relevant dosage forms).
Scale-up and site transfer: tech transfer from sponsor plants to the CDMO.

How to map CDMO suppliers to specific NDCs

Pull the NDC for the strength and dosage form.
Use FDA’s registration and listing to match NDC-labeled manufacturer entities to registered facilities.

Source: FDA’s drug establishment registration and NDC-linked labeling are the basis for facility-to-product mapping.

How does FDA Orange Book status affect amoxicillin supplier choices and generic entry risk?

Answer: For amoxicillin, most immediate-release generics are long marketed; the more actionable “supplier choice” problem in the near term is typically supply continuity and quality system capability rather than exclusivity-driven barriers.

Where exclusivity matters

New formulations (extended-release, novel taste-masked systems, or new combinations with beta-lactamase inhibitors) can shift the supplier landscape because new formulation patents and ANDA-specific design constraints affect manufacturing approvals.
Single-entity amoxicillin vs. combination products: combination products (for example, with clavulanate) may have separate patent and regulatory histories that constrain formulation supply chains.

Source: FDA Orange Book is the reference for approved drug listings, patents, and exclusivity indicators.

What patents protect amoxicillin formulations, and do they change supplier availability?

Answer: Patent protection for amoxicillin itself is often expired or narrow for current immediate-release dosage forms, but patents can still protect:

formulation approaches (e.g., suspension stability)
specific manufacturing methods
certain combination products or dosing regimens

Common patent types that influence suppliers

Composition/formulation patents (excipients, particle size distribution for oral suspensions)
Method-of-manufacturing patents (granulation, drying, blending parameters)
Use and dosing patents (less common for basic amoxicillin)
Combination-product patents (where amoxicillin is paired with another active)

Source: Patent protection is tracked through FDA Orange Book listings for approved products and patent families tied to specific ANDAs and NDA holders.

When does amoxicillin lose exclusivity, and who can launch generics after that?

Answer: For widely marketed immediate-release amoxicillin products, exclusivity barriers usually do not govern new supplier qualification because multiple ANDA and abbreviated marketing pathways already exist. Any “date-driven” supplier shift is more likely tied to:

new NDA approvals
new formulation approvals
new combination-product approvals
site-specific approvals and manufacturing changes

Launch scenario that matters for suppliers

Generic entry and substitution depend on FDA approval status (ANDAs with current labeling) and supplier qualification, not just exclusivity dates, for this product category.

Source: FDA Orange Book governs exclusivity and patent-linked timing; FDA labeling and ANDA approvals determine what’s legally marketable.

What is the Orange Book status of amoxicillin, and which patent holders matter most?

Answer: Orange Book entries depend on the specific NDA/ANDA product: formulation, strength, and dosage form. The supplier set that matters is the ANDA holders and NDA holders listed for each product.

How to use Orange Book to build a supplier map

For each amoxicillin NDC strength and dosage form, identify the corresponding application number in the Orange Book.
Record NDA/ANDA holder and listed patents.
Link application holder to NDC-labeled manufacturer(s) for supply forecasting.

Source: FDA Orange Book.

Which amoxicillin manufacturers are active in contract supply, and what are the likely quality and regulatory constraints?

Answer: Active contract supply is best inferred from NDC-labeled finished-dose manufacturing entities and their DERL site registrations, then cross-checked against inspection history and quality system indicators.

Key constraints that limit qualified suppliers

GMP compliance and facility readiness
validation capability for suspension and solid oral dosage
ability to scale during shortages without drifting out of validated ranges
supply chain robustness for API availability and intermediate sourcing

Source: FDA DERL identifies registered facilities; regulatory compliance is evidenced in inspection and compliance records.

What does the amoxicillin supply chain look like by geography and compliance model?

Answer: Amoxicillin supply is global and segmented by manufacturing capability and compliance maturity. Finished-dose supply chains often run through U.S.-registered sites even when API is sourced internationally.

Geographic segmentation that affects sourcing

API-intensive sourcing from major global penicillin supply hubs
Finished-dose final manufacturing and packaging within regional GMP networks
distribution through wholesalers and direct-to-pharmacy channels

Source: Facility registration and listing provide the operational map; FDA regulatory frameworks define compliance expectations.

How do shortage events change amoxicillin suppliers and lead times?

Answer: During amoxicillin shortages, the practical change is which NDCs remain supply-available and which manufacturing sites ramp production. Supplier switching is often fastest for:

dosage forms that share similar manufacturing lines
suppliers with validated scale-up plans
companies with pre-qualified API sources

Operational response typically seen

NDC substitution toward alternate package sizes or strengths
ramp by secondary approved manufacturing sites
increased reliance on certain wholesalers and distributors

Source: FDA and supplier transparency mechanisms often highlight shortage conditions and impacted products; facility registration indicates whether ramping is feasible.

How strong is the competitive landscape for amoxicillin sourcing (generic vs. brand)?

Answer: Amoxicillin immediate-release is a commodity-like generic category in many markets. The competitive differentiators for suppliers are:

supply reliability and lead times
quality system stability
ability to meet label and packaging configurations at scale

Competitive comparison lens

Brand owners: control product design and label-specific specifications; may use multiple contract manufacturing partners.
Generic firms: compete on ANDA approvals, bioequivalence, and consistent GMP execution.
CMOs: compete on capacity availability for dosage forms and change-control throughput.

Source: ANDA/NDA status is derived from FDA Orange Book; manufacturing identity comes from FDA labeling and DERL.

Key Takeaways

“Amoxicillin suppliers” in operational terms are the FDA-listed finished-dose manufacturers for each NDC and the DERL-registered API manufacturing sites that support those products.
For immediate-release amoxicillin, supplier constraints typically come from capacity, GMP execution, and API/intermediate availability, not from exclusivity timing.
The fastest route to a defensible supplier list for sourcing or litigation risk is an NDC-to-manufacturer mapping using DERL, then cross-linking the product’s application to FDA Orange Book entries.

FAQs

1) How do I find the FDA-registered manufacturing sites for a specific amoxicillin NDC?
Use the NDC to identify the labeled manufacturer and cross-check facility registrations in FDA DERL.

2) Are amoxicillin suspension manufacturers different from tablet/capsule manufacturers?
Often yes, because suspension formulation, fill-finish, and stability controls differ and may be executed on separate GMP lines.

3) What drives lead-time changes for amoxicillin during shortages?
Capacity at registered sites and availability of upstream intermediates and API feedstock, which determines which NDCs can ramp.

4) Do amoxicillin patents affect supplier switching between generic products?
For most immediate-release products, patent barriers are usually not the binding constraint; switching risk is more driven by regulatory status of specific formulations and manufacturing approvals.

5) How can I compare supplier quality risk across amoxicillin manufacturers?
Compare the registered sites tied to relevant NDCs and evaluate their regulatory track record using FDA compliance and inspection records linked to those facilities.

References (APA)

U.S. Food and Drug Administration. (n.d.). Drug Establishment Registration and Listing (DERL) System. https://www.fda.gov/drugs/drug-establishment-registration-and-listing
U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
U.S. Food and Drug Administration. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

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