Suppliers and packagers for LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rising	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	206006	ANDA	Rising Pharma Holdings, Inc.	57237-001-14	14 BLISTER PACK in 1 CARTON (57237-001-14) / 1 KIT in 1 BLISTER PACK (57237-001-01)	2016-10-14

Executive summary Copackaged lansoprazole/amoxicillin/clarithromycin (lansoprazole-based triple therapy) is typically sourced through multi-tier supply chains that include (1) active pharmaceutical ingredient (API) manufacturers for lansoprazole, amoxicillin, and clarithromycin; (2) finished-dose manufacturers that table/capsulate triple-therapy packs; and (3) packaging and labeling vendors that support “copackaged” retail and hospital distribution. Without a specific brand name, strength, pack configuration (e.g., 7-day vs 10-day), and FDA label/NDC, the supplier universe cannot be pinned to named vendors or verified sources.

Which companies supply copackaged lansoprazole amoxicillin clarithromycin triple therapy (retail and hospital)

Copackaged triple therapy supply is usually split across two categories: (a) API and intermediate suppliers and (b) finished-dose and pack-out suppliers. In US and EU channels, multiple entities can touch the product without being the “copack” label holder.

Common supplier roles in lansoprazole/amoxicillin/clarithromycin copackages

1. API manufacturers
   • Lansoprazole API and intermediates
   • Amoxicillin API and intermediates
   • Clarithromycin API and intermediates
2. Dosage form manufacturers
   • Lansoprazole delayed-release capsules/tablets
   • Amoxicillin capsules/tablets
   • Clarithromycin tablets/capsules
3. Pack-out and secondary packaging vendors
   • Unit-of-use blistering/bottling
   • Day-count or course packaging (trial/antibiotic regimen packs)
   • Cartoning, labeling, and serialization (where required)
4. Distribution and repack partners
   • Wholesalers and contract logistics providers supporting hospital channel

What to look for when identifying “copackaged” suppliers

• Finished product label holder and NDC-to-MANUFACTURER mapping (US)
• Packaging label language: “Distributed by,” “Manufactured for,” or “Packaged by”
• FDA labeling “Manufactured for” lines (often identify the packer/labeler more precisely than the API source)
• Batch release testing sites (GMP) listed in quality sections

What APIs and intermediates suppliers exist for lansoprazole, amoxicillin, and clarithromycin

Triple therapy copackages depend on APIs with different supply constraints and typical sourcing geographies.

Lansoprazole API supply characteristics

• Proton pump inhibitor API production relies on specialized chemistry and controlled moisture/humidity handling for intermediates.
• Lansoprazole supply chains often include multiple API makers across China and India, with some Western/EU secondary sourcing.

Amoxicillin API supply characteristics

• Amoxicillin API is commonly produced by several established beta-lactam API suppliers with known capacity in India and China.
• Finished dose often depends on antibiotic-grade fermentation and side-chain chemistry.
• Core constraints include beta-lactam contamination control and validated cleaning procedures across shared lines.

Clarithromycin API supply characteristics

• Clarithromycin production requires macrolide isolation and crystallization control.
• High variability in solvent systems and polymorph/particle-size specifications impacts downstream capsule/tablet performance.

How do API suppliers translate into copackaged product suppliers

A copack supplier list is only partly derived from API manufacturers because finished pack-outs may be performed by contract manufacturers and packers that do not produce the APIs.

Typical mapping logic used in supplier due diligence

• If the label shows “manufactured for” or “distributed by,” identify the labeled finished-dose manufacturer.
• If the label indicates “packaged by,” prioritize the pack-out vendor.
• For API, identify the likely upstream supplier set via:
  • DMF holders (if publicly available for relevant DMFs)
  • Consistency of API supplier across product lots and changing labeler statements
  • GMP inspection footprint for API plants (regulatory databases)

What is the Orange Book status of lansoprazole amoxicillin clarithromycin copackaged products

If no specific FDA product (brand/NDC/strength/form) is identified, Orange Book patent and exclusivity mapping cannot be completed. Copackaged regimens usually include multiple patents (drug product, method-of-use, and sometimes formulation/process). Supplier status and filings also depend on which applicant listed the NDA/ANDA referencing the regimen.

Which generic entry risks exist for copackaged lansoprazole triple therapy

Generic risk differs based on whether the copack is:

• a single NDA product with multiple NDC components, or
• a dispensing pack assembled under a finished label.

Key risk drivers

• Bioequivalence and dissolution requirements for each component
• Ability to source APIs that meet crystal form and impurity specs
• Packaging validation and course-of-therapy labeling requirements
• Patent and exclusivity periods tied to specific brand configurations

What formulations are protected by patents for triple therapy

Formulation protection can cover:

• Delayed-release design for lansoprazole
• Film coating for clarithromycin tablets/capsules
• Cross-contamination controls for antibiotic lines
• Pack labeling/combination claims if the applicant is seeking regimen-level exclusivity

Without a specified brand/NDA, patent numbers and protected formulation claims cannot be listed.

Last updated: June 2, 2026

What patent litigation affects lansoprazole amoxicillin clarithromycin copackaged products

Litigation is product-specific. Settlement structures can determine:

• launch timing
• exclusivity waivers
• authorized generic or distribution restrictions

Without identifying the brand/NDA/NDC, litigation cannot be enumerated to named cases.

What FDA regulatory pathway governs copackaged triple therapy (NDA vs ANDA)

Copackages are usually marketed as either:

• combination products with an NDA-defined regimen, or
• marketed as a set of individually approved products with pack-out under an arrangement.

Regulatory status depends on how the regimen is FDA-approved and labeled.

Key regulatory questions that determine supplier contracts

• Is the pack-out under the NDA manufacturing network?
• Are component drugs independently referenced by separate applications?
• Does the pack require additional bridging studies for regimen performance?
• Does labeling include regimen dose timing constraints tied to the approved text?

Commercial supplier landscape for copackaged triple therapy

A credible supplier landscape is built around three commercial signals:

1. Source-of-supply statements in the FDA label (finished-dose manufacturer and packer)
2. Changes in “manufactured for” and “packaged by” over time
3. Contract manufacturing announcements and site inspection patterns

A named supplier list cannot be produced without the specific marketed product identity (brand/NDC, strengths, and dosage forms).

Key Takeaways

• Copackaged lansoprazole/amoxicillin/clarithromycin supply is typically organized by API manufacturers (upstream) and finished-dose/pack-out manufacturers (downstream).
• Supplier identification for copackages must be anchored to the exact FDA-labeled product (brand/NDC, strength, dosage forms, pack configuration).
• Without product identity, a named, verifiable supplier list cannot be generated for this regimen.

FAQs

1. How can I identify the copack manufacturer on the label for lansoprazole/amoxicillin/clarithromycin regimens?
2. What documents link API suppliers to finished-dose lots for triple therapy?
3. Do copackaged regimens require separate stability and packaging validation from the individual components?
4. How do DMFs for lansoprazole, amoxicillin, and clarithromycin affect supplier qualification?
5. What drives cost and supply continuity risk for amoxicillin-based triple therapy packs?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Reports and Labeling (Drugs@FDA). U.S. Food and Drug Administration.
3. FDA. Drugs@FDA. U.S. Food and Drug Administration.