Suppliers and packagers for prozac

prozac

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3104-02	100 CAPSULE in 1 BOTTLE (0777-3104-02)	1993-01-13
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3105-02	100 CAPSULE in 1 BOTTLE (0777-3105-02)	1988-02-01
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936	NDA	Dista Products Company	0777-3105-30	30 CAPSULE in 1 BOTTLE (0777-3105-30)	1988-02-01

Suppliers for Prozac (fluoxetine): API, key formulation inputs, contract manufacturing, and sourcing risk map

Last updated: June 3, 2026

Prozac’s supply chain splits into (1) fluoxetine API manufacture and (2) finished-dose manufacturing for capsules and tablets. The U.S. market is dominated by large global generics and branded supply networks, but Prozac’s current availability and supplier roster depends on (a) which dosage form is being supplied, (b) the label holder at purchase time, and (c) whether the product is branded or an authorized generic. Without dosage-form specific product identifiers and current label/ANDA assignment, a complete, accurate supplier list cannot be produced.

Which companies supply fluoxetine API used to make Prozac?

Featured snippet answer: Fluoxetine API is supplied by specialized small-molecule API manufacturers, typically via global procurement networks. The exact company list for Prozac depends on the specific dosage form and the U.S. labeler at the time of sale.

API supply: what to map in procurement

• Chemical route and stereochemical control for fluoxetine (selective formation and crystallization control).
• Impurity profile compliance for regulatory specifications.
• Scale capability for annual demand spikes tied to branded versus generic mix.
• Supply continuity planning for solvent and intermediate bottlenecks.

Where API suppliers appear in practice

• FDA Drug Master File (DMF) holders tied to ANDA submissions for fluoxetine HCl products.
• Labeler/Manufacturer-of-record statements on the finished product label.
• Authorized manufacturing sites listed in FDA approval packages for the relevant NDA/ANDA.

Who manufactures Prozac capsules and tablets under the FDA label?

Featured snippet answer: Finished-dose manufacturing is performed by the product’s manufacturer of record, which can differ from the API supplier and can change with packaging site swaps and contract manufacturing.

Dosage forms that alter supplier lists

• Prozac oral capsules (varied strengths)
• Prozac tablets (varied strengths, depending on market availability)

How to identify the manufacturer-of-record that matters commercially

Procurement and litigation mapping usually relies on:

• FDA labeler/manufacturer-of-record on the commercial package
• NDA/ANDA linkages for the specific strength and dosage form
• Contract manufacturing arrangements that shift packaging and release testing sites

What excipients and formulation inputs are required to make Prozac?

Featured snippet answer: Prozac tablet and capsule manufacturing depends on standard oral solid formulation excipients, with the exact bill of materials varying by strength and dosage form.

Common input categories for solid oral fluoxetine products

• Capsule shell components (gelatin and/or non-gelatin alternatives where used)
• Film coating components for tablets (where applicable)
• Tableting excipients (binders, disintegrants, lubricants)
• Stabilizers and moisture control materials where specified
• Packaging materials (bottles, blister systems) and desiccants where required

Sourcing risk points

• Gelatin sourcing constraints and availability by origin/grade
• Coating polymer and pigment supply continuity
• Cross-site raw material qualification for release testing consistency

How do API and finished-dose suppliers differ in Prozac’s supply chain?

Featured snippet answer: The API supplier and the finished-dose manufacturer are often different entities; contract manufacturing and packaging site changes are common.

Typical split of responsibilities

• API manufacturers supply fluoxetine HCl meeting API specs.
• Finished-dose manufacturers receive API under controlled specs and produce, test, and release tablets or capsules.
• Packaging contractors may handle filling, bottling/blistering, and secondary packaging.

What contract manufacturers handle fluoxetine finished dosage manufacturing in the U.S.?

Featured snippet answer: Contract manufacturers vary by strength and dosage form, and the responsible CMO at purchase time is identified on the FDA label/packaging.

How the supplier picture changes over time

• CMOs swap for capacity management and cost optimization.
• Packaging sites relocate without changing the product’s labeler identity.
• Authorized generics use the same formulation but different manufacturer-of-records.

What FDA regulatory filings reveal Prozac ingredient and manufacturing sourcing?

Featured snippet answer: DMFs and ANDA/BLA review documents expose API and sometimes process-related supplier details, while the product label exposes finished-dose manufacturer-of-records.

Regulatory signals used by procurement and litigation teams

• DMF holders tied to fluoxetine HCl used in approved generics
• Strength-specific ANDA formulations and manufacturing sites
• Site additions and manufacturing changes over time

What generic entry risks affect Prozac supply and supplier reliability?

Featured snippet answer: Supply stability risks rise when multiple strengths transition between suppliers or when API sourcing is concentrated among limited API producers.

Risk vectors for oral solid SSRIs like fluoxetine

• API-only constraints: limited API producer capacity or intermediate shortages.
• Multi-site dependence: finishing and packaging sites can introduce separate failure modes.
• Quality system events: deviations or recalls at any step can shift supply to alternate sites.

Key Takeaways

• Prozac supply depends on two distinct layers: fluoxetine API and finished-dose manufacturing.
• Supplier identity changes by dosage form and manufacturer-of-record at purchase time.
• Regulatory submissions (DMFs and ANDAs) and the product label are the primary systems to map reliable ingredient and site suppliers for procurement, licensing, and litigation.

FAQs

1. How can I identify the manufacturer-of-record for a specific Prozac strength?
   Use the manufacturer details printed on the commercial package for that strength and dosage form.

2. Do Prozac capsule and tablet versions use the same suppliers?
   Not necessarily. Finished-dose sites and packaging contractors can differ by dosage form and strength.

3. Where do DMFs show fluoxetine API sourcing?
   DMF holders for fluoxetine HCl are tied to approved generic applications that use the API, revealing API supply sources.

4. What parts of the Prozac supply chain are most prone to shortages?
   Fluoxetine API and key excipient inputs for solid oral manufacturing, plus downstream packaging capacity, are the most common constraints.

5. Can Prozac supply be affected by manufacturing site changes even without reformulation?
   Yes. Site transfers, packaging site swaps, and contractual changes can alter release testing capacity and logistics lead times without changing the formulation.

References

1. FDA. Drug Approval Reports for approved drug products (NDA/ANDA labeler and manufacturing information). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drug Master Files (DMF). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process