Suppliers and packagers for synarel

synarel

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	SYNAREL	nafarelin acetate	SPRAY, METERED;NASAL	019886	NDA	Pfizer Laboratories Div Pfizer Inc	0025-0166-08	1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY	1990-02-13

SYNAREL Suppliers (API and Finished-Dose) and IP-Controlled Manufacturing Footprint

Last updated: May 29, 2026

Suppliers for “Synarel” depend on the exact product form and market (US vs EU vs other territories) because “Synarel” is a brand used for nafarelin acetate (a gonadotropin-releasing hormone, GnRH) and the supply chain varies by region, dossier holder, and Orange Book or national register listings.

Who supplies SYNAREL (nafarelin acetate) in the US and what are the key manufacturers?

Answer: The US supply of nafarelin acetate under the “Synarel” brand is tied to the NDA holder’s commercial and manufacturing relationships, which are reflected through FDA listing records (Orange Book for exclusivity and patent-related changes, plus FDA label/labeler and facility data).

What does “Synarel” map to in regulatory terms (active ingredient and strength)?

• Brand: Synarel
• Active ingredient: Nafarelin acetate
• Therapeutic class: GnRH agonist
• Common dosage forms (varies by market): nasal spray
• The “supplier” set is defined differently for:
  • API manufacture (chemical synthesis and controls)
  • Finished-dose manufacturing (fill-finish, packaging)
  • Market release testing and distribution

How to identify true SYNAREL suppliers (not just distributors)?

US “supplier” identification typically splits into:

• Labeler/Holder (who markets the product)
• Manufacturing sites (NDA/ANDA manufacturing facilities listed with FDA)
• Patented technology constraints (Orange Book-linked manufacturing and formulation improvements)

What suppliers provide nafarelin acetate API and how concentrated is the supply?

Answer: Nafarelin acetate API supplier concentration is usually limited because the API requires specialized peptide-like chemistry controls and nasal formulation compatibility testing. The enforceable constraint is often not only supplier availability but also regulatory qualification of the finished-dose dossier and related manufacturing changes.

API sourcing pathways that determine “supplier” status

• NDA holder domestic manufacturing
• Contract manufacturing (API and/or sterile nasal device fill-finish)
• Licensed API supply under supply agreements tied to dossier ownership

What drives supplier switching risk for nafarelin acetate nasal spray?

• Device and spray-formulation integration
• Stability and extractables/leachables for container-closure
• Consistent particle size or dissolved drug performance (formulation-specific)
• Long-cycle regulatory changes for manufacturing site moves

Which companies manufacture SYNAREL finished-dose nasal spray (fill-finish and packaging)?

Answer: Finished-dose “Synarel” manufacturing is typically performed by one or more qualified fill-finish sites, which can differ by strength, packaging configuration, and revision history. The practical supplier set is anchored to the NDA dossier’s manufacturing site listings and any post-approval facility supplements.

What facilities usually sit in the finished-dose supply chain?

• Bulk drug substance handling and formulation compounding
• Filling into nasal spray containers
• Device assembly and packaging
• Quality control release testing and stability programs

What is the Orange Book status of SYNAREL and does that constrain supplier changes?

Answer: Whether and how supplier changes are constrained depends on Orange Book-listed patents and whether manufacturing or formulation modifications trigger additional regulatory filings or patent exposure.

How Orange Book listings affect supplier strategy

• If Orange Book patents cover formulation, device, or manufacturing methods, a new supplier site may still be feasible but can create:
  • IP exposure in litigation or licensing
  • Changes requiring patent-relevant supplements or amendments
• If patents are expiring or already expired, supplier substitution typically accelerates.

Are there FDA generics or authorized suppliers for nafarelin acetate nasal spray that compete with SYNAREL?

Answer: Supplier competition comes from:

• Generic NDA holders (ANDA filers for nafarelin acetate nasal spray)
• Authorized generics (if any arrangement exists in a given market)
• Parallel product supply (varies by country)

What to look for to map supplier pressure

• ANDA entry history and approval dates
• Labeler/manufacturer listings for competing equivalents
• Manufacturing facility overlap with the brand dossier’s supply chain

How does biosimilar risk apply to SYNAREL?

Answer: Biosimilar risk does not apply. Nafarelin acetate is a small molecule GnRH agonist, not a biologic.

Key Takeaways

• “Synarel” supplier mapping is dossier- and jurisdiction-dependent. Supplier status is determined by the FDA-registered labeler/holder and FDA-registered manufacturing sites, not by casual distribution.
• The “supplier” question for nafarelin acetate breaks into API sourcing and finished-dose nasal spray fill-finish, each with different qualification and stability constraints.
• Orange Book-linked patents can constrain supplier switching indirectly through patent coverage of formulation or manufacturing methods, affecting licensing and litigation posture.

FAQs

1. How do I identify the true manufacturing suppliers behind Synarel nasal spray in FDA records?
   Use the NDA labeler and the FDA-registered manufacturing facility listings tied to the drug product, then cross-check with Orange Book-linked patent change history.

2. Do Synarel suppliers differ by strength or packaging configuration?
   Yes. Finished-dose manufacturers can vary by strength, packaging format, and supplement history.

3. Can a contract manufacturer supply nafarelin acetate for Synarel without FDA dossier updates?
   No. Supplier changes generally require regulatory supplements reflecting the new facility’s qualification and controls.

4. What patent categories most often affect supplier change for nafarelin acetate nasal spray?
   Formulation, composition-of-matter, and method-of-manufacture patents tied to the drug product and/or delivery system.

5. Is there biosimilar competition risk for Synarel?
   No. Nafarelin acetate is a small molecule.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA Drug Label Information and SPL data for “Synarel” (nafarelin acetate). (Accessed 2026).