Last updated: May 24, 2026
FETZIMA is a brand of levomilnacipran hydrochloride extended-release (ER) capsules. Commercial supply for the US market depends on (1) levomilnacipran API manufacture, (2) ER capsule formulation and scale-up, and (3) packaging and distribution under the brand holder’s supply agreements. The critical “suppliers” are therefore the API and dosage-form manufacturing contractors, plus the packaging/distribution entities listed on FDA drug application and label-manufacturing sections.
What companies manufacture the levomilnacipran API used for FETZIMA?
Featured-snippet answer: API and drug-product manufacturing are typically performed by contract manufacturing organizations (CMOs) under the brand holder’s quality agreements; the exact names are identified on the FDA label and application manufacturing sections for FETZIMA.
Which entities are listed for API and drug-product manufacturing on FETZIMA labeling?
FETZIMA labels identify the firm responsible for manufacturing and packaging of the finished ER capsule product in the US. The “pharmaceutical supplier” list for a product is built from these label entries, which typically show the responsible manufacturer and sometimes contract sites for capsule filling and packaging.
How to interpret “manufacturer” vs “labeler” in FETZIMA supplier mapping
- Labeler: the firm that markets the product under the NDC.
- Manufacturer: the firm(s) responsible for finished dosage manufacture and packaging for specific NDCs.
- API supplier: often not named on label; it is usually revealed through application manufacturing details, DMF references, and/or inspection records.
Who fills and packages FETZIMA extended-release capsules for different NDCs?
Featured-snippet answer: FETZIMA’s US supply is NDC-specific. Different capsule strengths can map to different manufacturing and packaging sites.
How many FETZIMA strengths exist and why that matters for supplier mapping
FETZIMA is supplied in multiple strengths (capsules). Each strength can be produced and packaged by the same or different manufacturing sites depending on scale, supply allocation, and packaging configurations.
What packaging steps typically define the “supplier” footprint
For an ER capsule, the supplier footprint commonly includes:
- API conversion to an ER-compatible composition
- Blending and encapsulation (drug-layer or capsule filling)
- ER technology-specific process steps (controlled-release performance)
- Packaging (bottles and cartons) and distribution under GMP controls
What are the contract manufacturing (C&MO) roles in the FETZIMA supply chain?
Featured-snippet answer: FETZIMA supply chains split into API, solid oral dose formation, ER performance control, and primary-secondary packaging. Each stage can be handled by different specialist suppliers.
API manufacture role
API manufacturers provide GMP material meeting levomilnacipran specifications, including impurity profile and particle attributes relevant to ER formulation performance.
Dosage-form manufacture role
ER capsule manufacturing requires:
- blending suitable for consistent release kinetics
- validated encapsulation fill mass and uniformity
- process controls and stability for long-term release characteristics
Packaging and labeling role
Packaging suppliers ensure:
- bottle/carton configuration accuracy
- label compliance to FDA requirements
- chain-of-custody and serialization readiness where applicable
Which firms are “suppliers” in the Orange Book and FDA regulatory records for FETZIMA?
Featured-snippet answer: The Orange Book identifies the drug product listing tied to application information. The practical “supplier list” comes from the approved labeling and the manufacturing information for each NDC.
Where Orange Book listings connect to supplier identity
Orange Book record fields connect to:
- applicant and sponsor (brand holder for the listed drug)
- NDA/ANDA application linkages
- exclusivity and patent metadata that affects generics and potential supplier substitution
Does the Orange Book list API suppliers?
Typically, it does not list API suppliers directly. Supplier names usually appear in:
- label manufacturer sections
- application site information
- inspection and facility databases
How do generic and biosimilar entry risks affect FETZIMA supplier leverage?
Featured-snippet answer: FETZIMA is small-molecule oral ER. Generics can pressure supply strategy and CMO allocation, but supplier substitution depends on ANDA launch timing and quality comparability.
What generic entry pressure does to contracting
If generic approvals are imminent, brand suppliers may:
- expand CMO allocation buffers
- renegotiate capacity reservations
- adjust packaging inventory positioning
- increase lot-release frequency to reduce stockouts
What a supplier bottleneck looks like for ER capsules
For ER oral solids, common bottleneck risks include:
- encapsulation line capacity
- blending and ER critical process parameter constraints
- coating or release-modifying formulation bottlenecks (if applicable)
- packaging line availability
What is the FDA status of FETZIMA that drives supplier operations?
Featured-snippet answer: Supplier operations track with NDA manufacturing controls, stability programs, and inspection readiness. Any changes to manufacturing sites require prior approval or reporting depending on type.
What FDA manufacturing control changes do to supplier contracts
When manufacturing changes are proposed, suppliers typically must support:
- comparability protocols
- validation batches
- bridging stability data
- CMC updates and inspection readiness at the new site
What litigation or patent events affect FETZIMA supply and supplier decisions?
Featured-snippet answer: Patent and exclusivity status affects generic entry timing, which in turn affects procurement planning and CMO capacity allocation.
How patent estate timing influences supplier strategy
- Longer exclusivity reduces generic substitute incentives.
- Shorter remaining exclusivity increases incentives for brand holders to secure supply continuity and protect shelf inventory.
Key Takeaways
- “Suppliers for FETZIMA” in practice means API and finished dosage manufacturers plus packaging contractors identified through FDA label manufacturing sections and application manufacturing records.
- Supplier identity is NDC- and strength-specific for finished dose manufacturing, and API suppliers are usually not named on the public-facing label.
- ER capsule supply chain decisions are driven by CMO capacity, encapsulation and release-performance critical process controls, and packaging availability.
FAQs
- Who is the labeler of FETZIMA (levomilnacipran) in the US?
- Do different FETZIMA strengths use different manufacturing and packaging sites?
- Are levomilnacipran API suppliers named on the FETZIMA prescribing information?
- How does CMC change approval work if FETZIMA moves to a new manufacturing site?
- What supply chain disruptions most often impact ER capsule products like FETZIMA?
References (APA)
- U.S. Food and Drug Administration. (n.d.). FETZIMA (levomilnacipran) prescribing information and label manufacturing sections. FDA.
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FETZIMA, levomilnacipran ER). U.S. FDA.
