Suppliers and packagers for ELLA

ELLA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474	NDA	A-S Medication Solutions	50090-5422-0	1 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACK	2020-05-11
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474	NDA	HRA PHARMA AMERICA, INC.	73302-456-01	1 BLISTER PACK in 1 CARTON (73302-456-01) / 1 TABLET in 1 BLISTER PACK	2020-05-11

Suppliers for the Pharmaceutical Drug ELLA (Levonorgestrel 1.5 mg Emergency Contraception): Who Manufactures the Tablet and How the Supply Chain Works

Last updated: May 23, 2026

ELLA is marketed as an emergency contraceptive tablet containing ulipristal acetate (UPA). The supplier base for “ELLA” in the US and EU is split between (1) upstream API and (2) finished-dose tablet manufacturing, with additional roles from packaging and release testing. The specific named suppliers vary by country and by marketing authorization holder.

Who supplies ELLA (ulipristal acetate) tablets in the US and EU?

Short answer: Finished-dose production and release for ulipristal acetate emergency contraception is typically handled by contract manufacturers in the EU, while API is produced by chemical manufacturers supplying European and global pharma buyers. The “supplier” that matters for procurement and regulatory filings is the drug product manufacturer on the relevant marketing authorization and label, not a universal vendor.

What entities are typically listed as ELLA suppliers?

For each national product label and application, the following supplier roles appear:

• Marketing authorization holder (MAH): legal entity responsible for the authorization and product oversight.
• Drug substance (API) manufacturer: produces ulipristal acetate.
• Drug product manufacturer: manufactures the finished tablets.
• Packager/releaser: repackaging and final release testing site(s).
• Contract testing labs: conduct QC release and stability.

Country-by-country supplier naming patterns

Supplier names for ELLA-style products differ because:

• marketing authorizations are held by different MAHs in different regions
• batch release can be assigned to multiple sites
• product can switch finished-dose suppliers after manufacturing transfer

What is the upstream API supplier chain for ulipristal acetate (UPA)?

Short answer: Upstream supply is ulipristal acetate API manufacturing, typically concentrated in a limited number of specialty chemical suppliers with validated production of the active substance and the ability to support regulated supply.

How API supply is contracted

Procurement structures usually map to:

• long-term supply agreements for API bulk
• quality agreements linking API specs to drug product requirements
• regulatory traceability for batch manufacturing and testing

What to look for in documentation

For a supplier due diligence package, the key “proof points” are:

• API manufacturer named in regulatory submissions (where available)
• CEP (if used) or DMF-linked references for ulipristal acetate
• evidence of GMP compliance for API site and drug product site
• batch COAs and impurity profiles aligned to finished-dose specifications

Which finished-dose manufacturers make ELLA tablets?

Short answer: Finished-dose tablet manufacturing for ulipristal acetate emergency contraception is carried out by contract manufacturing and packaging-release networks that sit behind the MAH.

What roles count as a “tablet supplier”

In practice, “supplier” can mean any of these:

• tablet manufacturing site (mixing, granulation, tableting, coating)
• packaging site (blister packing and cartoning)
• batch release site (QP release under EU rules)
• secondary manufacturing (serialization, labeling changes)

What tends to change over time

Manufacturing transfers often shift:

• blister-pack production site
• QP release location
• tablet compression or coating line These changes can happen while the MAH stays constant.

What does the FDA pathway imply for ELLA supplier identification?

Short answer: In the US, identifying “suppliers” for a branded emergency contraceptive is usually achievable by linking the product label, application references, and manufacturing/release sites listed in regulatory documents. The supplier names are tied to the NDA/ANDA labeling and current manufacturing supplements.

Orange Book listing: what it can and cannot tell you

If the Orange Book lists the product, it typically includes:

• NDA number
• active ingredient and dosage form strength
• listed patents and exclusivities (where applicable)

It generally does not map every upstream API vendor directly, so a complete supplier map requires marrying regulatory identity to CMC manufacturing site references in applications and label sections.

What patents and regulatory exclusivities affect supplier availability for ELLA?

Short answer: The supplier universe is shaped by product exclusivity and the availability of approved CMC packages for alternate manufacturing sites, not just by patent coverage.

Practical impact on generic or alternative supply

• If exclusivity blocks entry of an equivalent, finished-dose supply remains concentrated with the brand’s supply chain.
• Even if generics exist, manufacturing transfers require regulatory readiness and validated process transfer.

What generic entry risks exist for ELLA that could alter the supplier base?

Short answer: For emergency contraception with ulipristal acetate, the main supply shifts occur when:

• an approved alternative product launches
• an MAH changes commercial supply partners
• manufacturing transfers expand capacity

What procurement risk looks like

Supplier concentration risk shows up as:

• single-site bottlenecks for tablets or packaging
• long lead times for release testing materials
• constrained blister capacity

How does ELLA compare with levonorgestrel emergency contraception suppliers?

Short answer: Levonorgestrel (a competing emergency contraception category) has a broader supplier base because the active and product formats have more generics and manufacturing capacity in multiple regions. Ulipristal acetate supply is typically more concentrated.

What changes operationally between the two categories

• Different APIs and different validated impurity controls
• Different formulation robustness requirements
• Different regulatory and CMC validation histories

Key Takeaways

• “Suppliers for ELLA” is not a single vendor list. It is a supply chain split across API producers, tablet manufacturers, packagers, and batch release sites.
• Supplier identities vary by country and by marketing authorization holder.
• Regulatory documents and product labels are the source for the manufacturer and release site names that matter for procurement and compliance.
• Capacity and supplier concentration are core supply risks for emergency contraception products due to packaging and release constraints.
• Generic and manufacturing-transfer events can change the supplier base faster than patent discussions alone.

FAQs

1. How can I identify the drug product manufacturer for ELLA on the label in my country?
2. Do Orange Book listings include API supplier names for ulipristal acetate emergency contraception?
3. What manufacturing and packaging sites are typically involved in emergency contraception tablet supply chains?
4. What documentation is used for supplier qualification of ulipristal acetate API and tablet release?
5. How do manufacturing transfers for branded tablets typically affect supply continuity for ELLA?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. European Medicines Agency. (n.d.). EPAR product information pages and public assessment summaries. European Medicines Agency. https://www.ema.europa.eu/en/medicines