Suppliers and packagers for generic pharmaceutical drug: olanzapine pamoate

olanzapine pamoate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173	NDA	H2-Pharma LLC	61269-660-20	1 KIT in 1 CARTON (61269-660-20) * 1.4 mL in 1 VIAL * 3 mL in 1 VIAL	2009-12-11
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173	NDA	H2-Pharma LLC	61269-661-20	1 KIT in 1 CARTON (61269-661-20) * 2 mL in 1 VIAL * 3 mL in 1 VIAL	2009-12-11
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173	NDA	H2-Pharma LLC	61269-662-20	1 KIT in 1 CARTON (61269-662-20) * 2.7 mL in 1 VIAL * 3 mL in 1 VIAL	2009-12-11

OLANZAPINE PAMOATE Suppliers: Key Manufacturers, Contract Packaging, and Market Structure for Long-Acting Injectable (LAI)

Last updated: May 23, 2026

OlanZAPINE pamoate is supplied through a concentrated supply chain dominated by the original LAI manufacturer and a small set of contract manufacturing and packaging partners. For procurement, the practical supplier set is defined by: (1) the FDA-registered LAI manufacturers of olanzapine pamoate drug product, (2) the suppliers of the sterile injectable fill-finish system (vials/syringes) and packaging, and (3) upstream APIs and pamoate salt intermediates used for the long-acting formulation.

What companies supply olanzapine pamoate drug product in the US?

The US market for olanzapine pamoate long-acting injection is served by the FDA label holder that supplies the approved presentation(s), with additional manufacturing and distribution roles typically handled through contract manufacturing and packaging networks.

Who is the label holder and primary supplier?

OlanZAPINE pamoate is marketed in the US as ZYPREXA RELPREVV (long-acting injection). The primary supplier for procurement is the label holder that distributes the commercial product and holds the NDA for the approved LAI.

How do contract manufacturers typically plug in?

For LAIs, contract manufacturing and packaging partners typically support:

• sterile drug product manufacturing (aseptic processing, sterilization validation, long-acting suspension controls)
• packaging and labeling for distribution channels
• secondary packaging for US commercial distribution (cartons, NDC-level packaging)

LAI manufacturing is capacity constrained, which usually means fewer suppliers than for oral olanzapine products.

Which manufacturers produce olanzapine pamoate API or pamoate salt intermediates?

OlanZAPINE pamoate uses olanzapine base converted into the pamoate salt form, with API-grade controls tied to impurity profiles and particle attributes relevant to long-acting release performance.

API supply chain pattern for pamoate salts

Across pamoate-salt LAIs, API supply is typically limited to:

• API manufacturers that can supply olanzapine with consistent impurity and polymorph behavior
• salt-conversion and isolation sites that deliver pamoate salt meeting particle size and free base conversion targets
• upstream solvent and reagent suppliers qualified under GMP change control for controlled precipitation and milling steps

Procurement implication

In procurement practice, buyers usually source via the finished drug product supply chain (NDA manufacturer network) rather than purchasing API directly, unless they support authorized compounding or secondary manufacturing, because LAI performance depends on particle and suspension characteristics that are set in drug product manufacturing rather than API alone.

What contract manufacturers and CMOs support sterile fill-finish for LAI suspensions?

OlanZAPINE pamoate is a sterile injectable suspension. Fill-finish and packaging vendors tend to be shared across multiple sterile LAIs and depot injectables.

Fill-finish capabilities that matter for olanzapine pamoate

Qualified CMO capabilities generally include:

• aseptic fill-finish in vials (or prefilled syringes, if applicable to the label)
• long-acting suspension handling controls (agitation, homogeneity, particle settling prevention during filling)
• in-process controls for viscosity and particulate distribution
• terminal sterilization vs. aseptic processing (route depends on formulation and label controls)
• lyophilized vs. suspended formats (olanzapine pamoate is supplied as a suspension)

How to identify the actual fill-finish sites

In practice, the only definitive way to map CMOs to olanzapine pamoate is through:

• the FDA label manufacturing information
• the drug product section in the NDA/PL product description
• inspection and establishment listing data tied to the product’s NDA

What packaging suppliers support NDC-level distribution for olanzapine pamoate?

Packaging for LAIs is built around sterile primary packaging plus US-compliant cartons and labels.

Packaging components commonly used

• sterile vial and stopper systems (or equivalent primary packaging for the labelled presentation)
• secondary cartons, inserts, and NDC-specific labeling
• distribution-ready kits aligned to administration requirements

Role of packaging and labeling vendors

Packaging vendors generally do not touch the sterility-critical aseptic unit operations, but they do:

• assemble kits
• apply regulatory labels and blister/carton packaging (depending on presentation)
• manage serialization and lot traceability for US distribution systems

What is the FDA Orange Book status of ZYPREXA RELPREVV suppliers?

Supplier mapping for IP and regulatory risk is driven by Orange Book listings. For olanzapine pamoate, the relevant question is which patents and exclusivities are listed against the NDA and how that limits generic substitution and biosimilar-like entry.

How to use Orange Book to bound supplier risk

Orange Book entries tie:

• active ingredient and dosage form
• patent numbers and patent types (drug substance, drug product, use)
• expiration dates and any exclusivity extensions

Procurement and licensing teams use this to forecast when alternative suppliers can legally launch.

When does olanzapine pamoate lose exclusivity and open generic entry risk?

Exclusivity and patent expiration determine whether additional suppliers can legally enter through:

• 505(b)(2) (for modified presentations or clinical bridging)
• ANDA with Paragraph IV certifications (for generic long-acting formulations)
• 505(j) pathways are typically not relevant for non-biologics like this LAI unless a different regulatory classification applies.

Timing levers that control supplier diversification

• patent expiration for the LAI composition and method-of-use
• patent term adjustments and exclusivity extensions
• 180-day exclusivity for first Paragraph IV filer (if triggered)

What generic or LAI competitors exist for olanzapine pamoate?

If exclusivity and patents block generic entry, procurement tends to rely on limited suppliers. If some entries are cleared, suppliers can diversify across:

• generic LAI versions under ANDA
• 505(b)(2) entrants using bridging and formulation changes

Commercial impact

When entry occurs, wholesale and hospital purchasing often shifts to whichever supplier offers:

• availability (lot supply continuity)
• tender pricing
• supply reliability for LAI administered schedules

Which litigation or settlement agreements affect supply of olanzapine pamoate?

In LAI markets, patent litigation and settlements influence:

• launch dates
• agreed noninfringement scopes
• product design “carve-outs” that may keep certain formulations or manufacturing routes off-limits for generics

How settlements change supplier timelines

Settlements typically set:

• “carve-out” dates for generic launches
• design-around requirements
• ongoing supply rights during interim periods

Procurement teams rely on these to avoid purchasing into an environment where launch timing is unstable.

Which regional suppliers matter for procurement outside the US?

OlanZAPINE pamoate availability varies by jurisdiction and procurement channel, and supply tends to follow:

• where the product is approved and marketed
• whether local MAHs appoint distributors or co-distributors
• if local sterile manufacturing partners support national distribution

Export and parallel trade constraints

For depot injectables, substitution is constrained by:

• cold chain requirements (if any; many injectable depots are not cold-chain dependent, but handling requirements still apply)
• labeling and administration kit compatibility
• reimbursement rules that limit interchangeability

Key data needed to finalize a supplier list (drug product, sterile fill-finish, packaging)

A defensible supplier list for olanzapine pamoate requires mapping by establishment and role. In a procurement-ready deliverable, the supplier list should include:

Drug product manufacturing suppliers

• FDA-registered establishments that manufacture olanzapine pamoate LAI drug product
• label holder(s) and contract manufacturing sites

Sterile fill-finish suppliers

• establishments responsible for aseptic processing and vial/syringe filling
• primary packaging subcomponent suppliers only if explicitly disclosed by regulatory listings

Packaging and distribution suppliers

• packaging and labeling vendors aligned to NDC-level configuration
• distribution arrangements that control availability

Key Takeaways

• OlanZAPINE pamoate LAI sourcing is dominated by the label holder supply chain and a limited set of sterile fill-finish and packaging partners qualified for long-acting injectable suspensions.
• Supplier diversification depends on FDA regulatory status (Orange Book and exclusivity) and any patent litigation or settlements that govern generic launch timing.
• For procurement and licensing decisions, the only actionable supplier mapping is establishment- and NDC-linked: drug product manufacture, sterile fill-finish, and packaging operations.

FAQs

1. What is the difference between olanzapine oral generic suppliers and olanzapine pamoate LAI suppliers?
2. How does Orange Book patent listing affect when new suppliers can launch generic olanzapine pamoate?
3. What manufacturing attributes of olanzapine pamoate suspension drive CMO qualification?
4. Do packaging and labeling suppliers for olanzapine pamoate change across NDCs or carton configurations?
5. How do Paragraph IV challenges typically affect availability and pricing of long-acting injectable LAI products like olanzapine pamoate?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Referenced for patent/exclusivity framework).