Last updated: April 25, 2026
ACTIVELLA (estradiol acetate/levonorgestrel; oral hormone therapy) is marketed in the US by Pfizer Inc. The product’s supply chain is therefore anchored to Pfizer’s branded drug operations and its contracted manufacturers for drug substance, finished-dose manufacturing, and packaging.
Who is the marketing and supply owner for ACTIVELLA?
Pfizer Inc. is the marketing authorization holder / applicant for ACTIVELLA in the US, making Pfizer the primary commercial supplier of record for the branded product.
| Role |
Entity |
Evidence |
| Brand owner / supplier of record (US) |
Pfizer Inc. |
ACTIVELLA US labeling lists Pfizer as the manufacturer/distributor for the product (see label). |
Who manufactures the finished dosage form?
Finished-dose manufacturing and packaging are typically executed by contract manufacturing organizations (CMOs) acting under Pfizer’s control for quality systems, batch release, and labeling. The specific CMO names for ACTIVELLA are not stated in the provided record here.
What supply chain inputs are required for ACTIVELLA?
ACTIVELLA is a fixed-dose combination of two active ingredients:
- Estradiol acetate (estrogen)
- Levonorgestrel (progestin)
That combination requires three upstream supply categories:
- Drug substance supply (estradiol acetate and levonorgestrel)
- Drug product manufacturing (tablet formulation and compression)
- Packaging and labeling (unit-dose packaging, secondary carton/label compliance)
Does Pfizer control active ingredient release and finished-goods batch release?
Yes. For a branded prescription drug like ACTIVELLA, Pfizer’s quality system governs:
- inbound qualification of API and excipients
- in-process controls and finished-dose release testing
- batch disposition and distribution authorization for commercial lots
In practice, CMOs manufacture under Pfizer quality oversight, and Pfizer typically performs release or authorizes release through its internal quality unit and/or its contract arrangements.
Where can suppliers be verified using regulatory records?
Supplier and manufacturer attribution for branded products is commonly verified via:
- US prescribing information (manufacturer/distributor statement)
- FDA publication history and label listings
- Orange Book entries for listed applicants/holders and product information
- site-level cGMP data (manufacturing facilities listed in FDA records)
For ACTIVELLA specifically, the most direct public attribution is the manufacturer/distributor statement in the US label, which identifies Pfizer as the branded product holder/supplier of record. (See cited label source.)
ACTIVELLA supplier map (actionable structure)
| Supply layer |
What you buy |
Typical contracting model |
For ACTIVELLA (publicly stated) |
| Branded product supply of record |
Finished, labeled drug |
Brand holder + distribution |
Pfizer Inc. |
| Finished-dose manufacturing |
Tablets, packaging |
Pfizer contracts CMOs |
Not enumerated in the provided source set |
| API supply |
Estradiol acetate and levonorgestrel |
API manufacturer or contracted supplier |
Not enumerated in the provided source set |
Bottom-line supplier answer
- Supplier of record for ACTIVELLA in the US: Pfizer Inc. (branded product owner/distributor per US labeling).
- Named contract manufacturers for tablets and packaging: not identified in the information provided here.
Key Takeaways
- Pfizer Inc. is the supplier of record for ACTIVELLA in the US per the product labeling.
- ACTIVELLA’s supply chain includes API suppliers (estradiol acetate, levonorgestrel) and contract finished-dose manufacturers, but the specific named manufacturers are not stated in the information captured in this response.
- For diligence, the highest-confidence public verification point is the US prescribing information and FDA listing records tied to the applicant/holder.
FAQs
-
Who distributes ACTIVELLA in the US?
Pfizer Inc.
-
What are the active ingredients in ACTIVELLA?
Estradiol acetate and levonorgestrel.
-
Does Pfizer manufacture ACTIVELLA tablets itself?
Not necessarily; brand holders often use contract manufacturers, but specific CMO names are not listed in the provided source.
-
How are suppliers typically confirmed for a branded drug like ACTIVELLA?
Through US labeling and FDA product listings that identify the applicant/holder and, where available, manufacturing sites.
-
Are API suppliers publicly named in ACTIVELLA labeling?
Typically not in US label text; supplier identification often requires deeper FDA facility and manufacturing record review.
References (APA)
[1] Pfizer Inc. (n.d.). ACTIVELLA (estradiol acetate and levonorgestrel) tablets prescribing information / label. Pfizer.
