Suppliers and packagers for kaletra

kaletra

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251	NDA	AbbVie Inc.	0074-3956-46	1 BOTTLE in 1 CARTON (0074-3956-46) / 160 mL in 1 BOTTLE	2010-06-18
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-0522-60	60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60)	2010-06-18
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-3008-60	60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60)	2020-04-08
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-4014-12	120 TABLET, FILM COATED in 1 BOTTLE (0074-4014-12)	2020-04-08
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-6799-22	120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22)	2010-06-18

Suppliers and packagers for kaletra

Last updated: May 26, 2026

Kaletra (lopinavir/ritonavir) suppliers: who makes the drug substance and finished product, and what supply sources exist?

Kaletra is marketed by AbbVie and consists of lopinavir boosted with ritonavir. Supply for Kaletra originates from a vertically linked manufacturing and packaging network controlled through AbbVie and its contract manufacturing partners. The most material supplier categories for procurement, licensing, or risk mapping are (1) finished-dose manufacturing (film-coated tablets and oral solution), (2) API manufacturing for lopinavir and ritonavir, (3) packaging and labeling, and (4) cold-chain or special-handling requirements for the oral solution (no cold chain is routinely required, but handling and stability controls apply).

What suppliers make Kaletra tablets and oral solution (finished dosage forms)?

Primary finished product manufacturer

• AbbVie (through its manufacturing sites and affiliates) is the marketing authorization holder and the central control point for commercial supply of Kaletra globally.

Contract manufacturing and packaging (CMO/packager channels)

Kaletra finished-dose supply is commonly executed through:

• AbbVie internal manufacturing sites for drug product bulk and final fill-finish for oral solution
• CMOs for tableting, coating, bottling, blisters, and cartonization, depending on geography and procurement contracts
• Packers/labelers that operate under site agreements and comply with GMP serialization and country-specific labeling

Because procurement and regulatory submissions are site-specific, the supplier list that matters for diligence is the set of GMP site names tied to the specific product presentation (tablets vs oral solution) and the jurisdiction (US vs EU vs key ex-US markets).

Who supplies lopinavir and ritonavir APIs for Kaletra?

API supplier structure

Kaletra’s supply chain divides into:

• Lopinavir API
• Ritonavir API
• Blending and composition steps that produce the lopinavir/ritonavir ratio used in the finished product

API sources

API sourcing for Kaletra generally comes from:

• AbbVie API manufacturing sites and/or
• specialized API CMOs that produce lopinavir and ritonavir under NDA-controlled specifications

For supplier due diligence, the actionable suppliers are those with:

• DMF access or reference-listed approvals for the relevant API
• site-specific GMP status
• history of batch release for lopinavir and ritonavir lots used in Kaletra

Which companies are listed as suppliers or manufacturers in regulatory filings for Kaletra?

US regulatory reference points

In the US, the manufacturer and site information that procurement teams use typically comes from:

• FDA drug product labeling and associated manufacturing statements
• Orange Book listings when applicable to NDA-linked product disclosures
• Drug Approval Package components (CMC modules) that identify listed manufacturing sites for the drug substance and drug product

EU reference points

In the EU, the supplier reality is captured through:

• EMA product information and manufacturing authorization (where available by product and site)
• national marketing authorization documentation, which includes manufacturing and batch release sites

How does Kaletra supplier structure differ by dosage form (tablets vs oral solution)?

Tablets

Tablet supply requires:

• API receipt and testing
• blending and granulation processes
• compression
• coating
• blistering or bottling
• serialization and labeling

Tablet suppliers thus split into:

• tablet manufacturing sites
• packaging and labeling sites

Oral solution

Oral solution supply is more sensitive to:

• liquid formulation handling
• viscosity and stability controls
• container closures and leak testing
• bottle fill-finish and labeling

Oral solution supply thus splits into:

• liquid manufacturing and fill-finish sites
• bottling and secondary packaging

What supply risks exist for Kaletra (API continuity, CMO dependency, and batch release)?

API continuity risks

• Single-site or limited-site API production for either lopinavir or ritonavir
• capacity constraints at CMOs that also serve competing antiretroviral programs
• regulatory remediation events that can pause site approvals

Drug product risks

• coating or fill-finish bottlenecks
• packaging material lead times (bottles, blisters, cartons, leaflets)
• label-country synchronization and serialization constraints

Batch release risks

• GMP deviations that trigger rework or supplemental testing
• analytical method changes requiring regulatory notification

What is the Orange Book status of Kaletra and how does it affect supply via generics?

Kaletra itself is a branded NDA product. The Orange Book matters for downstream supply only when there are listed generic approvals or patent-protected changes that shift sourcing responsibilities.

The supplier question becomes:

• whether any approved generics rely on different API sourcing footprints
• whether those generics have different listed drug product manufacturing sites

This affects procurement leverage and continuity if supply interruptions hit the branded supply chain.

Which generic or biosimilar entry risks affect Kaletra supply availability?

Kaletra is not a biologic, so the relevant competition risk is generic entry rather than biosimilars.

If generic versions are available in key markets:

• they can reduce dependency on AbbVie’s supply
• they can introduce additional API supplier networks
• they can shift demand away from Kaletra presentations under AbbVie contracts

Supplier risk mapping should treat generics as parallel sourcing options with different manufacturing geographies and regulatory release practices.

What does supplier due diligence require for Kaletra procurement?

A diligence-grade supplier checklist for Kaletra should capture:

• Manufacturing site identity for the exact presentation (tablets vs oral solution)
• GMP status and inspection history for the site(s) involved
• API source identity for lopinavir and ritonavir
• DMF or regulatory reference linkage for the API (if relevant to technology transfer or compliance audits)
• batch release and CoA traceability practices
• serialization and labeling compliance controls for the destination market

Kaletra supplier map (procurement-ready structure)

Supply layer	What to identify for Kaletra	Typical supplier type
API: lopinavir	GMP API manufacturer name and site	API CMO or AbbVie site
API: ritonavir	GMP API manufacturer name and site	API CMO or AbbVie site
Drug product bulk	Site making lopinavir/ritonavir blend into tablet or solution bulk	AbbVie site or CMO
Final dosage form	Tablet pressing/coating or oral solution fill-finish	AbbVie site or CMO
Packaging	Bottle/blister + carton + leaflet	Packager/labeler
Batch release	QP batch release and release testing workflow	AbbVie quality group and/or releaser site

Key Takeaways

• Kaletra supply is anchored by AbbVie as the marketing authorization holder, with internal manufacturing and CMO/packager support by dosage form.
• Supplier identification for procurement must be site-specific and presentation-specific (tablets vs oral solution).
• For API continuity, the critical suppliers are those that manufacture lopinavir API and ritonavir API under GMP and regulatory linkage (DMF/reference pathways).
• Supplier risk is primarily driven by site capacity, GMP status, and batch-release continuity, not by molecule complexity.

FAQs

1. How do I identify the exact manufacturing site for Kaletra tablets in my target country?
2. Which are the most common contract manufacturers involved in antiretroviral drug product packaging, and how do I verify them for Kaletra?
3. Does Kaletra oral solution use different suppliers for fill-finish than the tablet line?
4. What regulatory documents show the listed Kaletra drug substance and drug product manufacturing sites?
5. If Kaletra supply is constrained, what alternative sourcing routes exist through approved generics and their listed manufacturers?

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/
3. European Medicines Agency. (n.d.). EPAR and product information for Kaletra. https://www.ema.europa.eu/