Share This Page
Suppliers and packagers for ETOPOPHOS PRESERVATIVE FREE
✉ Email this page to a colleague
ETOPOPHOS PRESERVATIVE FREE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cheplapharm | ETOPOPHOS PRESERVATIVE FREE | etoposide phosphate | INJECTABLE;INJECTION | 020457 | NDA | H2-Pharma, LLC | 61269-410-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61269-410-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2009-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ETOPOPHOS PRESERVATIVE FREE
ETOPHOPOS Preservative Free (etoposide) Supply Chain: Key Suppliers, API and Fill-Finish Inputs, and Sourcing Risks
ETOPHOPOS PRESERVATIVE FREE is a preservative-free injectable formulation of etoposide. Supply chain sourcing for this product typically breaks into: (1) etoposide API, (2) formulation-grade excipients and sterile processing components for a preservative-free unit, (3) sterile fill-finish and packaging, and (4) finished-goods distribution into the FDA-regulated marketplace.
No supplier list can be produced from the information available in this prompt alone.
Who supplies the etoposide API used in ETOPHOPOS PRESERVATIVE FREE?
A complete, accurate supplier map requires confirmed commercial manufacturing sources for the etoposide API used specifically for this “preservative free” branded injectable. That mapping is usually derived from:
- FDA drug product labeling and manufacturing section (for the finished drug)
- The referenced listing in the Orange Book for the specific NDA/BLA and dosage form
- DMF-linked API disclosures (if incorporated by reference)
- Public procurement and GMP inspection records that identify API and sterile fill-finish sites
Without those identifiers, a supplier list would be incomplete or incorrect.
What API-grade requirements apply to preservative-free etoposide injectables?
Preservative-free injectables usually require tightly controlled:
- bioburden and endotoxin limits at release
- aseptic processing validation
- container-closure integrity
- particulate and extractables controls specific to the final container system
Supplier eligibility is governed by QMS and GMP release capabilities, not just commodity chemical availability.
Which excipient suppliers support a preservative-free etoposide injection?
Preservative-free parenterals typically rely on formulation components that are controlled for sterility and compatibility with etoposide. In practice, the excipient supply chain includes:
- sterile-grade water systems and formulation-grade solvents where applicable
- buffering agents and solubilizers used in the branded product
- nitrogen/CO2 inerting supplies for manufacturing environments
- sterile filtration media and single-use tubing sets used during aseptic processing
A correct excipient supplier list must be tied to the specific product’s labeled formulation and the manufacturing site’s approved vendor master.
Who performs the sterile fill-finish for ETOPHOPOS PRESERVATIVE FREE?
For preservative-free injectables, the fill-finish stage is often the principal sourcing risk point because it determines:
- sterile filtration train design
- fill volume control and visual defect rate
- rubber stopper and vial compatibility (extractables/leachables)
- packaging configuration (vial type, stopper type, labeling format)
The specific fill-finish contractor and the primary GMP site must be confirmed for the branded product, not inferred from generic etoposide injectables.
What sterile packaging components are typically sourced for this product?
A supplier map would enumerate:
- vial glass supplier (type and source)
- stopper supplier (composition and dimensions)
- flip-off seals and caps
- sterile labeling and carton materials
- cold-chain or temperature-controlled logistics components if required
A confirmed BOM for “ETOPHOPHOS PRESERVATIVE FREE” is required to name suppliers.
What is the Orange Book status of ETOPHOPHOS PRESERVATIVE FREE and how does it affect sourcing?
Orange Book status informs:
- market exclusivity constraints and competition timing
- whether multiple labeled manufacturers exist under the same NDA
- whether generic preservative-free equivalents are approved
A supplier list cannot be validated without the NDA number, applicant, and product identifiers.
What companies compete for supply of preservative-free etoposide injectables?
The competitive supply landscape depends on:
- which NDA holders distribute the finished product
- which contract manufacturers do fill-finish for those labelers
- whether authorized generics exist for this specific presentation
Without confirmed product identifiers, any company list risks mixing “etoposide injection” variants with different preservative status, strengths, container configurations, or labelers.
How do licensing and manufacturing agreements constrain supplier availability?
In parenteral oncology injectables, long-term supply often locks in:
- approved API suppliers via qualification and change-control constraints
- exclusive or semi-exclusive excipient supply arrangements
- validated sterile process windows at fill-finish sites
- packaging line allocations
Supplier substitution is typically possible only after comparability studies and regulatory updates, which limits rapid switching during shortages.
When do shortages occur for preservative-free etoposide, and what breaks first?
When supply tightens, the earliest constraints usually include:
- API lead times due to solvent recovery and crystallization batch capacity
- sterile filtration consumable shortages
- vial and stopper shortages tied to specific container-closure requirements
- fill-finish line downtime driven by quality investigation backlogs
A shortage timing analysis requires historical FDA shortage announcements and actual product identifiers for “ETOPHOPHOS PRESERVATIVE FREE.”
Key Takeaways
- ETOPHOPHOS PRESERVATIVE FREE supply is best understood as a chain across etoposide API, preservative-free excipient-grade inputs, sterile fill-finish, and packaging.
- Naming suppliers requires product- and site-level identifiers (NDA and labeled manufacturing section) to avoid mixing different etoposide injection presentations (preserved vs preservative-free; vial/stopper configurations; strengths).
- Supplier switching is constrained by sterility assurance, container-closure integrity, and validated aseptic processing.
FAQs
- Which API suppliers manufacture etoposide used for preservative-free oncology injectables?
- What excipients and solvents are required for preservative-free etoposide injection formulations?
- How can I identify the sterile fill-finish contractor for a specific NDA presentation?
- Do preservative-free etoposide products have different packaging supplier requirements than preserved versions?
- What regulatory documents show the manufacturer and packager for ETOPHOPHOS PRESERVATIVE FREE?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database). https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Shortages. (Database). https://www.accessdata.fda.gov/scripts/drugshortages/
More… ↓
