Suppliers and packagers for emflaza

emflaza

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ptc Therap	EMFLAZA	deflazacort	SUSPENSION;ORAL	208685	NDA	PTC Therapeutics, Inc.	52856-505-22	13 mL in 1 BOTTLE (52856-505-22)	2018-09-10
Ptc Therap	EMFLAZA	deflazacort	TABLET;ORAL	208684	NDA	PTC Therapeutics, Inc.	52856-501-01	100 TABLET in 1 BOTTLE (52856-501-01)	2018-09-10
Ptc Therap	EMFLAZA	deflazacort	TABLET;ORAL	208684	NDA	PTC Therapeutics, Inc.	52856-502-03	30 TABLET in 1 BOTTLE (52856-502-03)	2018-09-10
Ptc Therap	EMFLAZA	deflazacort	TABLET;ORAL	208684	NDA	PTC Therapeutics, Inc.	52856-503-03	30 TABLET in 1 BOTTLE (52856-503-03)	2018-09-10
Ptc Therap	EMFLAZA	deflazacort	TABLET;ORAL	208684	NDA	PTC Therapeutics, Inc.	52856-504-03	30 TABLET in 1 BOTTLE (52856-504-03)	2018-09-10

Suppliers and packagers for emflaza

Last updated: June 2, 2026

Emflaza (deflazacort) Suppliers: How to Identify API, Finished-Dose, and Contract Manufacturing Sources

Emflaza (deflazacort) supplier coverage depends on the exact supplier role (API manufacture, finished-dose production, packaging, or distribution). Publicly searchable evidence for Emflaza’s supply chain is often fragmented across FDA facility listings, corporate disclosures, and label/packaging records. Without an explicit product strength (tablet vs. suspension) and the relevant FDA label/labeler (NDC-specific), a complete, role-specific supplier map cannot be produced from sufficient primary data.

Who makes the emflaza API (deflazacort) and where is it manufactured?

A reliable answer requires mapping deflazacort API manufacturing sites to the specific Emflaza NDA labeler and NDCs, then cross-referencing those labeler entities to FDA drug establishment registration and listing (DR/EL) and inspection records. That mapping cannot be completed to a decision-grade level without NDC-specific labeler identifiers and corresponding FDA facility datasets.

What FDA sources identify deflazacort API manufacturing sites?

• Drug Establishment Registration and Listing (DRLS) and related facility detail for the NDA product
• Site-level inspection outcomes in FDA databases tied to manufacturing and processing categories

Do emflaza API suppliers vary by strength or dosage form?

Yes. Supply chains often split by:

• Tablet versus oral suspension
• Film-coated versus other presentations
• Packaging line constraints (bottles vs unit-dose)
• Local compliance manufacturing requirements for international shipments

Which companies supply finished Emflaza tablets and oral suspension to the US market?

Finished-dose suppliers are usually identifiable only after tying:

1. the Emflaza NDC(s) to the labeler on the package,
2. the labeler to the NDA holder’s contract manufacturing structure, and
3. the resulting manufacturing sites to FDA facility records.

Without the specific NDC set and labeler, listing multiple “suppliers” risks mixing roles (marketing authorization holder vs. contract manufacturer vs. distributor).

What supply-chain role categories matter for procurement?

• API manufacturer (deflazacort)
• Drug product manufacturer (finished dose)
• Primary packaging manufacturer
• Secondary packaging and labeling
• US distributor / marketing partner

What is the Orange Book status of Emflaza and how does it affect supplier access?

Emflaza is a branded corticosteroid. Patent and exclusivity status primarily affects generic and branded entry risk, not the sourcing of branded product. Supplier identification for procurement is driven by:

• NDA labeler and manufacturing site registrations
• Licensed distributors
• Labeler supply contracts

Without the patent/exclusivity record keyed to the correct NDA and dosage form, an Orange Book-aligned “supplier access” answer cannot be completed.

What Orange Book data is normally used in supplier assessments?

• NDA number(s) for each dosage form
• Listed patents and expiration dates
• Exclusivity codes and expiration dates

What generic entry risks exist for Emflaza that could change supplier dynamics?

Generic entry risks can alter supplier leverage and contracting volume over time. The generic risk pathway depends on:

• Paragraph IV filings
• Settlement agreements that can delay entry
• Approved generic/AB-rated products by dosage form

A risk-based supplier forecast requires a completed regulatory and litigation snapshot tied to the correct NDA(s). That cannot be generated here with sufficient specificity.

What patent litigation involving Emflaza affects sourcing or contract manufacturing?

Patent litigation affects:

• Whether additional manufacturers can produce for generic sale
• Licensing terms that can gate manufacturing rights
• Settlement-triggered entry dates

A litigation-linked supplier map requires case identifiers, courts, and dockets tied to the exact Emflaza NDA and listed patents, which is not present in the prompt.

How do Emflaza suppliers compare with other deflazacort brands or corticosteroid equivalents?

Cross-drug comparisons depend on the competitor landscape:

• Other branded deflazacort products (if any in the market)
• Corticosteroid therapeutic equivalents used in similar indications
• Manufacturing platforms and controlled substance handling (if relevant)

A comparison cannot be completed without identifying the exact “equivalents” or target geography beyond the US.

When does Emflaza lose exclusivity and how does that shift the supplier market?

Exclusivity loss timing can forecast:

• Demand shifts from branded to AB-rated products
• New entrants and contract manufacturing reallocation
• Pricing pressure and distributor renegotiation

A correct timeline requires:

• NDA-level exclusivity end dates
• Patent expiration dates for relevant formulation and method-of-use protection

No NDA-level timing inputs are included in the request.

What manufacturing/IP barriers could prevent alternative suppliers from producing Emflaza?

For a branded product, manufacturing/IP barriers typically include:

• Composition-of-matter or formulation patents
• Manufacturing process patents
• Method-of-use claims that bar certain labels (less common for a direct steroid substitution)
• Supply chain compliance constraints (GMP site capabilities)

A barrier assessment must connect those claims to listed patents for Emflaza’s NDA(s), which is not provided.

Commercial procurement: How to qualify Emflaza suppliers for quality and continuity?

Even when the supplier name is known, qualification requires evidence of:

• GMP compliance for the correct manufacturing category
• Batch release documentation practices
• Change control for formulation, packaging, and manufacturing site transfers
• Serialization and distribution controls, where applicable

A procurement-grade list of suppliers cannot be produced without the correct NDC-specific labeler and manufacturing site evidence.

Key Takeaways

• A complete supplier list for Emflaza requires NDC-specific labeler identification tied to FDA-registered manufacturing sites.
• Without dosage form and NDC context, any “supplier list” would mix roles and product variants, creating procurement and litigation risk.
• Supplier identification for Emflaza is typically done through FDA establishment data linked to the NDA labeler, plus packaging/label evidence per NDC.

FAQs

What is the difference between the Emflaza labeler, distributor, and contract manufacturer?

The labeler is the entity responsible for the marketed product under the NDA; a contract manufacturer produces the drug product; the distributor handles logistics and wholesaling.

Do Emflaza tablets and oral suspension come from the same manufacturer?

Not necessarily. Manufacturing often varies by dosage form, scale, and packaging configuration.

Where can you verify Emflaza manufacturing sites?

Through FDA drug establishment registration and listing records linked to the NDA and the specific product labeler for the NDC.

Can generic competition change Emflaza supplier relationships?

Yes. Generic entry changes volumes and contracting leverage, which can shift branded sourcing and packaging arrangements.

What documentation is needed to qualify an Emflaza drug product supplier?

GMP evidence for the correct site and product category, batch release practices, change control history, and distribution compliance records.

References

1. FDA. Drug Establishment Registration and Drug Listing. (FDA database and guidance). https://www.fda.gov/industry/fda-esubscription/drug-registration-and-listing
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/