Suppliers and packagers for LIVALO

LIVALO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-104-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-104-90)	2019-05-16
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-204-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-204-90)	2019-05-16
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363	NDA	Kowa Pharmaceuticals America, Inc.	66869-404-90	90 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (66869-404-90)	2019-05-16

Suppliers and packagers for LIVALO

Last updated: May 26, 2026

Livalo (pitavastatin) Suppliers: APIs, Finished-Dosage Manufacturers, and Key Contract Partners

Livalo is marketed as pitavastatin calcium (brand name “Livalo” in the US). The supply chain divides into: (1) pitavastatin active pharmaceutical ingredient (API) suppliers and (2) finished-dose drug product (tablet) manufacturers that produce for the US market. Patent, regulatory, and product-readiness work in parallel with sourcing because most contractual risk sits at the drug-product manufacturing and packaging layer, not just the API.

What follows is a supplier map by function (API vs. finished-dose) and by market relevance (US/authorized sources).

Who supplies the pitavastatin API for Livalo?

Pitavastatin API supply is the foundational input. For statins, the market often uses a small set of specialized API plants with validated synthetic routes and tight control over polymorph, residuals, and stereochemical purity.

Typical pitavastatin API sourcing model

• API made by specialized API manufacturers with capability for pitavastatin calcium salt formation and consistent impurity profile.
• Regulatory filing alignment: API is supplied under quality agreements supporting the finished product manufacturer’s DMF/ASMF referencing in FDA submissions.
• Scale and continuity: statin manufacturing is capacity-constrained because multiple firms maintain dedicated lines for chiral intermediates.

Common API categories to check for in documents

• Pitavastatin calcium
• Pitavastatin intermediates (chiral intermediates that drive supply continuity)
• Solvates/polymorph control inputs used to hit finished-dose specs

Which companies manufacture the Livalo tablets (drug product)?

Drug product manufacturing covers:

• compression
• coating (if applicable)
• tablet polishing and imprinting
• packaging (bottles/blisters)
• labeling operations for country-specific requirements

Drug product supply chain structure

• Finished-dose manufacturer: produces tablets to the approved NDA/label.
• Packaging/secondary operations: may be performed by the same site or contract packaging partners.
• Quality release testing: can be internal or outsourced to qualified labs under the manufacturer’s quality system.

What is the FDA and Orange Book sourcing status for Livalo tablets?

The practical way to identify “who supplies” for the US market is to tie:

1. the FDA product record (labeler/manufacturer fields) to
2. Orange Book listings tied to the drug product and strength
3. the underlying CMC section references that indicate manufacturing sites.

Orange Book: what to look for

For each listed strength, the Orange Book generally lists:

• NDA number
• drug substance (active ingredient)
• drug product manufacturer and packaging firms
• listed patents and exclusivity that affect timing for generic entry

What this means for supplier visibility

• If the Orange Book lists a specific “Applicant/Manufacturer,” that name is the best starting point for finished-dose responsibility.
• The FDA labeler name can differ from the Orange Book applicant name due to corporate structure and contract manufacturing.

How many supplier sites support Livalo market supply?

In US statin supply chains, the typical pattern is:

• 1 to 3 primary finished-dose sites for routine supply
• additional alternate sites for surge capacity or during inspections and equipment downtime
• single or limited API sources due to the complexity of chiral chemistry and impurity control

This matters because contract manufacturing substitutions require CMC comparability packages and can take time during regulatory changeovers.

What contract manufacturing relationships exist for pitavastatin tablets?

Contract relationships for tablets typically fall into three tiers:

1) Primary tablet maker

A facility that runs the full tableting line with validated batch records and release testing.

2) Alternate tablet maker

Second facility qualified for commercial supply (often via tech transfer).

3) Co-pack/packaging partner

Bottling/blister filling, serialization support, and secondary packaging.

How do you verify Livalo suppliers in regulatory records?

Verification is done by triangulation:

• FDA product labeler/manufacturer fields (US prescribing label)
• Orange Book entries for the NDA product and strength
• CMC descriptions in the NDA and supplements
• DS and DP site references that show where manufacture and packaging occur

Which suppliers also produce generic pitavastatin calcium tablets?

This is a key risk lever for supply assurance. If generic entry occurs at scale, the same manufacturing ecosystem can supply both brand and generic product, changing leverage and price.

How to reason about overlap

• If an API plant sells pitavastatin to multiple finished-dose manufacturers, it becomes shared supply risk.
• If a finished-dose site makes both brand-labeled and generic-labeled tablets, it can affect continuity during inspections.

What supplier bottlenecks can affect Livalo availability?

Common bottleneck points:

• chiral intermediate supply constrained by a small number of producers
• API quality excursions tied to impurity out-of-spec
• tablet coating or compression line downtime at the finished-dose plant
• packaging shortages (bottles, closures, blister lidding film) impacting release timelines

Which logistics terms matter in Livalo supply contracts?

For pharma supply contracts, bottlenecks are managed with:

• Incoterms and delivery SLAs (lead times, temperature control if required)
• batch traceability requirements and chain-of-custody
• change control timelines for site swaps and process changes
• allocation rules during capacity constraints

What patent and exclusivity facts affect sourcing and supplier behavior for Livalo?

Even if a supplier exists, generic entry timing depends on FDA exclusivity and patent barriers, which affect:

• how quickly finished-dose manufacturers will reallocate capacity
• how aggressively API and packaging partners bid for new business

The supply market tightens when exclusivity delays reduce the number of near-term commercial opportunities for generics.

Key Takeaways

• Livalo’s “suppliers” split into pitavastatin calcium API producers and finished-dose (tablet) manufacturers, with packaging and release testing often adding a second layer of vendor risk.
• The highest-confidence way to identify the responsible commercial manufacturers is through FDA labeler/manufacturer fields and Orange Book product-specific entries tied to the NDA and strength.
• Supplier count is usually small for finished-dose sites and even smaller for API due to chiral synthesis and impurity control constraints.
• Contract manufacturing substitution during capacity shocks is constrained by CMC comparability and batch-release validation timelines.

FAQs

1. How can I identify the finished-dose manufacturer for Livalo tablets from FDA records?
   Check the FDA product labeler/manufacturer fields and confirm against the Orange Book listing for the NDA and strength.

2. Do Livalo API suppliers also supply generic pitavastatin calcium?
   Often yes at the API level, because API vendors may serve multiple finished-dose manufacturers; finished-dose sharing is less common but possible.

3. What are the most common causes of pitavastatin API supply disruptions?
   Chiral intermediate constraints, impurity profile drift, and manufacturing line capacity limits.

4. How does packaging sourcing affect Livalo availability?
   Bottle/closure and blister component shortages can delay release even when tablet manufacture is complete.

5. What CMC issues block rapid manufacturer switching for Livalo tablets?
   Tech transfer, process validation, impurity control, and comparability demonstration tied to the NDA.

References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. FDA Label Information for Livalo (pitavastatin).