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Suppliers and packagers for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
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OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ph Health | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 077742 | ANDA | Par Health USA, LLC | 49884-250-11 | 30 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-11) | 2012-11-26 |
| Ph Health | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 077742 | ANDA | Par Health USA, LLC | 49884-251-11 | 30 CAPSULE in 1 BOTTLE, PLASTIC (49884-251-11) | 2012-11-26 |
| Ph Health | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 077742 | ANDA | Par Health USA, LLC | 49884-252-11 | 30 CAPSULE in 1 BOTTLE, PLASTIC (49884-252-11) | 2012-11-26 |
| Ph Health | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 077742 | ANDA | Par Health USA, LLC | 49884-253-11 | 30 CAPSULE in 1 BOTTLE, PLASTIC (49884-253-11) | 2012-11-26 |
| Ph Health | OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 077742 | ANDA | Par Health USA, LLC | 49884-277-11 | 30 CAPSULE in 1 BOTTLE, PLASTIC (49884-277-11) | 2012-11-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Suppliers for Olanzapine and Fluoxetine Hydrochloride: API, Intermediates, and Finished-Dose Contract Manufacturing
Key point: “Olanzapine and fluoxetine hydrochloride” is not a single co-formulated product in the US. Supply is therefore best scoped as (1) olanzapine API and intermediates and (2) fluoxetine hydrochloride API and intermediates, then (3) finished-dose tablets/capsules via contract manufacturing and packing (secondary packaging). Supplier selection hinges on whether you need US Drug Master File (DMF) support, CEP/EDQM filings, controlled-substance logistics (fluoxetine is not controlled), cGMP inspection history, and whether you are targeting ANDA, 505(b)(2), or clinical supply.
Because the request does not specify target market (US/EU/ROW), dosage form (tablet, capsule, ODT, IR vs ER), and grade (USP, EP, biotech-grade not applicable), the supply map below is limited to supplier types and sourcing channels that are determinative for pharmaceutical procurement decisions. It does not name specific companies.
What companies supply olanzapine API, olanzapine intermediates, and finished tablets?
Key point: Olanzapine supply chains are primarily built around bulk API manufacturers (often DMF holders) and dedicated intermediate producers for the heterocycle and nitrile-bearing intermediates used in olanzapine synthesis.
API supply chain structure for olanzapine
Common procurement routes:
- DMF-listed API suppliers for ANDA filers (US)
- CEP-backed API suppliers (EU)
- Contract manufacturers producing tablets using purchased API (US/EU compliance packages)
- Intermediate suppliers supplying key building blocks (contract synthesis)
Typical categories searched in procurement:
- Olanzapine API (bulk, GMP)
- Olanzapine intermediate(s) (process-specific, often multiple)
- Drug product manufacture (compression, coating, imprinting, blistering)
Finished-dose manufacturing for olanzapine (tablet/ODT/coated)
Tablet and ODT manufacturing are commonly outsourced for:
- Compression and coating lines (IR vs ODT capability)
- Blister and HDPE bottle filling
- Stability programs and packaging qualification
Procurement checkpoints:
- Facility inspection readiness (FDA or EU GMP)
- Batch size capability aligned to commercial forecast
- Analytical methods transfer support (HPLC/GC, dissolution, polymorph control)
What companies supply fluoxetine hydrochloride API and fluoxetine intermediate synthesis?
Key point: Fluoxetine hydrochloride supply is mature, with many established API sources and multiple routes to the key anilide and propylamine-containing intermediates that feed the final salt formation.
API supply chain structure for fluoxetine hydrochloride
Common procurement routes:
- DMF holders for ANDA submissions
- CEP-backed API suppliers for EU compliance
- Intermediate producers supplying stepwise synthesis components
- Conversion to fluoxetine hydrochloride salt and particle engineering (if needed)
Procurement checkpoints:
- Salt form consistency (fluoxetine HCl)
- Impurity profile controls (regulatory-relevant genotoxic and process-related impurities)
- Polymorph and water content control if relevant to the form
Drug product manufacturing for fluoxetine (capsules/tablets)
Fluoxetine dosage forms vary by product:
- Capsules (common)
- IR tablets (common)
- Daily dose strengths (often 10 mg, 20 mg; product-specific)
Procurement checkpoints:
- Dissolution and disintegration performance by strength
- Line clearance and cross-contamination control
- Analytical method suitability for your planned product specification
Which suppliers support both olanzapine and fluoxetine hydrochloride for combination product packaging?
Key point: Even when a prescriber administers olanzapine and fluoxetine concurrently, the legal and manufacturing model is usually “two separate drugs,” not one fixed-dose combination. Packaging and labeling can be coordinated by a contract packaging organization, but API and drug-product manufacturing are typically separate.
There are two practical sourcing patterns:
- Two API suppliers and two drug-product manufacturers, then secondary packaging into co-ship kits.
- One drug-product manufacturer that provides both SKUs using its own API sourcing, with a single packaging/labeling partner.
Procurement checkpoints:
- Co-pack agreement for kits versus single-label regimens
- Stability and shelf-life alignment between both drug products
- Labeling and serialization support (US track-and-trace requirements apply depending on product)
How do you qualify olanzapine and fluoxetine API suppliers for ANDA or 505(b)(2) submissions?
Key point: Supplier qualification is dominated by documentation and auditability, not just price.
Minimum compliance package typically required:
- GMP certificate and batch records excerpt capability
- DMF access or cross-reference letter (US) when required
- Impurity and specification package (CoA model, acceptance criteria)
- Stability summaries and proposed retest periods
- Method validation packages or reference to pharmacopeia methods
- Change control history and tech-transfer readiness
Procurement checkpoints by molecule:
- Olanzapine: impurity set and solid-state form control (if product depends on crystallinity)
- Fluoxetine HCl: salt form and impurity control, including process impurities tied to key steps
What delivery models exist for olanzapine and fluoxetine hydrochloride supply: API, bulk, clinical, and commercial?
Key point: Contracting models determine lead times and regulatory pathway fit.
- API supply only
- Best for licensed formulators or contract drug-product manufacturing using your lead time and quality system.
- Drug product manufacture (finished dose)
- Best for branded generic operations needing packaged product under one quality system.
- Clinical supply
- Best for trials needing fast turnaround, flexible batch sizes, and stability start-up.
- Co-pack kits
- Best for concurrent regimen packaging. Requires strict labeling SOPs and stability alignment.
How does API lead time and raw-material availability affect olanzapine and fluoxetine procurement?
Key point: Both supply chains can be sensitive to:
- Intermediate availability
- Solvent and specialty reagent sourcing
- Lead time for final salt formation steps (fluoxetine HCl)
- Analytics capacity for release and stability
Procurement actions that de-risk:
- Dual-source qualification for key intermediates and API
- Safety stock strategy tied to your release testing throughput
- Forward procurement of long-lead intermediates
What are the common quality risks in olanzapine and fluoxetine hydrochloride supply?
Key point: The risks are repeatable and can be screened in supplier audits.
Olanzapine risks
- Solid-state form variation affecting dissolution
- Impurity levels tied to process route
- Batch-to-batch consistency and impurity control strategy
Fluoxetine hydrochloride risks
- Incorrect salt form or moisture variability
- Impurity profile drift due to route changes
- Particle size distribution impacts on dissolution and blend uniformity (if needed)
What should you look for in a contract development and manufacturing organization (CDMO) for these molecules?
Key point: A CDMO evaluation is a grid of capability, documentation, and inspection readiness.
Evaluation checklist:
- cGMP compliance track record and audit history
- Ability to meet your target dosage form and strength ranges
- Analytical lab capability for release and stability
- Batch size flexibility and tech transfer support
- Packaging capabilities (blister, bottle, unit-dose)
- Experience with ANDA-related documentation expectations
What licensing and IP constraints affect supplier selection for olanzapine and fluoxetine hydrochloride?
Key point: Pricing and feasibility depend on whether you are manufacturing your own API under freedom-to-operate or buying from suppliers whose supply is already operationally supported for your intended regulatory filing.
Procurement implication:
- Some suppliers may not support cross-border or filing-specific intended use unless contractual terms permit it.
- Change control and route changes may need alignment with your regulatory strategy.
What generic entry risks exist if you rely on a new supplier for olanzapine or fluoxetine?
Key point: Risk typically comes from product performance and regulatory comparability rather than from chemistry alone.
Risk drivers:
- Impurity profile mismatch leading to regulatory rejection
- Solid-state behavior differences (olanzapine)
- Particle size or dissolution behavior differences (fluoxetine and tablet/capsule performance)
- Insufficient stability to support shelf-life at commercial launch
Key takeaways
- Treat sourcing as two independent API and drug-product supply streams: olanzapine and fluoxetine hydrochloride.
- Supplier qualification is documentation-led: DMF/CEP status, GMP audit readiness, impurity specs, stability data, and tech transfer.
- Finished-dose co-pack kits are typically the operational path for “both drugs together,” not fixed-dose combination manufacturing.
- Quality risks are predictable: olanzapine solid-state/impurity control and fluoxetine salt/impurity and performance consistency.
- Lead-time and intermediate availability are often the bottlenecks; dual sourcing and forward procurement reduce launch risk.
FAQs
1) Can I source olanzapine and fluoxetine hydrochloride from the same supplier?
Yes, but in practice it depends on whether the supplier is active in both API markets and whether it can also manufacture both finished-dose forms under one quality system. Co-pack/kit providers can also coordinate both SKUs without sharing the same API supply chain.
2) What documentation matters most when buying olanzapine API for regulatory filings?
The supplier’s DMF support (or reference strategy), impurity/specification package, stability summary, GMP certificate, and change-control history.
3) What documentation matters most when buying fluoxetine hydrochloride API for regulatory filings?
Salt-form consistency documentation, impurity profile and acceptance criteria, stability data, and GMP release capability aligned with your planned filing strategy.
4) How do I reduce launch risk when switching olanzapine or fluoxetine API suppliers?
Use comparative impurity testing, solid-state/dissolution comparability testing (as applicable), and ensure stability coverage supports the shelf-life claim.
5) Are there any special handling or controlled-substance issues with fluoxetine hydrochloride?
Fluoxetine is not classified as a controlled substance under typical US regulatory categories, so supply-chain constraints are generally standard GMP chemical and shipping compliance rather than controlled-substance logistics.
References
(No sources cited. The prompt does not provide a product-specific scope (market, dosage form, filing type) and requires company naming that cannot be produced accurately without external validation.)
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