Suppliers and packagers for tri-sprintec

tri-sprintec

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	TRI-SPRINTEC	ethinyl estradiol; norgestimate	TABLET;ORAL-28	075808	ANDA	Teva Pharmaceuticals USA, Inc.	0555-9018-58	6 POUCH in 1 CARTON (0555-9018-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2003-12-29
Barr	TRI-SPRINTEC	ethinyl estradiol; norgestimate	TABLET;ORAL-28	075808	ANDA	Proficient Rx LP	63187-458-28	6 POUCH in 1 CARTON (63187-458-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2003-12-29
Barr	TRI-SPRINTEC	ethinyl estradiol; norgestimate	TABLET;ORAL-28	075808	ANDA	Preferred Pharmaceuticals Inc.	68788-6325-2	1 BLISTER PACK in 1 POUCH (68788-6325-2) / 1 KIT in 1 BLISTER PACK	2016-10-18

Suppliers and packagers for tri-sprintec

Last updated: June 5, 2026

TRI-SPRINTEC Drug Suppliers: Who Manufactures and Supplies Tri-Sprintec (Ethinyl Estradiol + Norgestimate)?

Tri-Sprintec is a combined oral contraceptive (COC) containing ethinyl estradiol and norgestimate. The “suppliers” market for Tri-Sprintec typically maps to (1) the branded product labeler/manufacturer responsible for FDA NDA supply, and (2) firms that supply contract manufacturing, packaging, and distribution under branded or generic supply agreements. Tri-Sprintec is commonly available in the US through the labeled manufacturer/distributor channel and in parallel through authorized or generic equivalents.

What matters for business decisions: identifying the FDA labeler/manufacturer (Orange Book/NDA chain) for the brand, and the contract manufacturing/packaging suppliers if you are underwriting supply continuity, API procurement leverage, or IP-based manufacturing constraints.

Who supplies Tri-Sprintec in the US market?

Primary supplier (FDA-labeled manufacturer/distributor): The key “supplier” for Tri-Sprintec for regulatory and procurement purposes is the labeler/manufacturer listed on the FDA drug label and Orange Book entry for the branded NDA. This is the entity that holds responsibility for the marketed finished dosage form’s regulatory standing and supply obligations tied to the NDA.

Channel suppliers: Wholesalers and GPOs distribute Tri-Sprintec, but these firms usually do not control API quality by design; they control logistics. For IP, regulatory, and interchangeability analysis, the relevant entities are the labeler/manufacturer and any disclosed contract manufacturing sites.

How do you identify the true supplier quickly?

1. Match the NDC for your product strength (Tri-Sprintec’s standard regimen is ethinyl estradiol 35 mcg and norgestimate 0.25 mg, tablets in triphasic pack).
2. Use the FDA labeler tied to that NDC to identify the finished-dose manufacturer/distributor.
3. Cross-check that labeler in the Orange Book listing for the active ingredients (ethinyl estradiol and norgestimate) and the NDA for Tri-Sprintec.

What companies manufacture Tri-Sprintec tablets (ethinyl estradiol + norgestimate) for the brand?

Brand finished-dose manufacturing is typically performed either by the NDA holder at company-owned facilities or via contract manufacturing organizations (CMOs) with site-specific inspections. For Tri-Sprintec, the practical approach is to use:

• Orange Book “Applicant/Patent Holder” records for the NDA
• FDA labeler and manufacturing locations on the package insert
• NDC-to-manufacturer mappings used by distributors

Supplier landscape pattern for COCs: for many branded COCs, API and excipients can come from specialized suppliers, while finished-dose blending/compression and packaging are frequently executed by a CMO or a second site under the NDA.

Are there contract manufacturing suppliers for Tri-Sprintec packaging and tablets?

For oral contraceptives, packaging and dispensing form a large part of the “supplier” footprint:

• Blister/strip packaging (cycle pack)
• Cartoning and unit-of-use labeling
• Serialization and distribution logistics (where applicable)

In the Tri-Sprintec supply chain, the contract packaging and secondary packaging suppliers are often identified through:

• FDA facility listings tied to the NDA/labeler
• site inspection data
• quality agreements between NDA holder and CMOs (rarely public in full detail)

Which raw material suppliers provide ethinyl estradiol and norgestimate used in Tri-Sprintec?

The raw-material supplier set splits into:

• API suppliers for ethinyl estradiol and norgestimate
• Excipients suppliers used in tablet formulation
• Packaging components suppliers (aluminum foil, PVC/PVDC blanks, printed lidding, carton stock)

Because raw-material procurement is frequently multi-sourced for continuity risk, the “API supplier” list changes over time and is not always tied to a single Tri-Sprintec manufacturer. For procurement and audit strategy, companies typically qualify multiple API sources and require CoA/DMF traceability.

What is the Orange Book status of Tri-Sprintec and how does it affect supplier options?

Orange Book status affects:

• Whether FDA-listed RLD exclusivity or listed patents constrain generic entry
• Whether other manufacturers can rely on AB-rated therapeutically equivalent listings
• Whether contract manufacturing for generic equivalents faces patent restrictions

For COCs like Tri-Sprintec, supply “options” depend less on API access and more on whether generic competitors can lawfully market the finished product and whether your formulation/manufacturing approach triggers IP exposure.

Do generic Tri-Sprintec equivalents change the supplier landscape?

Yes. When generics enter, the “supplier set” broadens:

• Multiple finished-dose manufacturers listed for the same strength and dosing regimen
• More NDCs tied to different labelers
• Different packaging configurations by generic maker

For buyers, that changes negotiating leverage and supply continuity, but it does not necessarily change the underlying excipient or packaging supplier ecosystem.

How do FDA regulatory and quality systems affect who can supply Tri-Sprintec?

Tri-Sprintec tablet supply depends on:

• FDA compliance history and inspection outcomes at the finished-dose manufacturing sites
• Establishment registration and product listing
• Quality systems capable of meeting CMC requirements for combination oral contraceptives

Oral contraceptives are typically manufactured under validated processes with strict control over:

• tablet weight and dissolution
• impurity profiles for ethinyl estradiol and norgestimate
• packaging integrity to prevent moisture/light degradation

Timeline: when do supplier constraints ease through generic entry?

Supplier constraints ease when:

• Brand exclusivity and listed patent protection lapse
• Generics launch with FDA approval for the dosage form
• Any patent litigation results in lifting of injunctions (if applicable)

For practical supplier planning, generic availability usually increases shortly after the regulatory-IP barrier is removed. The exact dates are driven by:

• NDA exclusivity periods
• listed patent expirations
• any Paragraph IV litigation or settlements

Competitive landscape: which manufacturers commonly supply generic equivalents of Tri-Sprintec?

Tri-Sprintec competes against multiple COC generics that are AB-rated. Generic suppliers for COCs frequently include large US generic manufacturers and specialty brand-to-generic transition companies that run oral solid dose facilities.

The supplier mix depends on:

• NDC coverage by each generic manufacturer
• availability in your contracted distribution tiers
• stocking behavior by wholesalers and specialty pharmacies

Supply continuity risks for Tri-Sprintec: what barriers exist for new suppliers?

Key barriers:

• validated formulation and process know-how for biphasic/triphasic dosing packs
• blister/cycle pack packaging line capability
• regulatory readiness for combination products
• ability to source API and excipients consistently across multiple batch cycles

In COCs, packaging bottlenecks can be the constraint, not API procurement.

Key Takeaways

• The “supplier” that matters for Tri-Sprintec is the FDA labeler/manufacturer associated with the Tri-Sprintec NDC and the Orange Book NDA entry for the branded product.
• Contract suppliers typically show up as CMOs for tablet manufacture and packaging vendors for blistering/cycling/carto ns tied to the NDA holder or labeler.
• Generic entry expands supplier options by adding multiple finished-dose manufacturers for AB-rated equivalents, improving negotiating leverage and supply continuity.
• Practical diligence focuses on NDC-to-labeler mapping, NDA/Orange Book listing confirmation, and manufacturing site eligibility for combination oral contraceptives.

FAQs

1) How do I confirm the Tri-Sprintec manufacturer tied to my specific NDC?
Match the NDC on the vial/box to the FDA labeler/manufacturer listing for that NDC, then cross-check against the Orange Book listing for the branded NDA.

2) Are there multiple tablet strengths or pack configurations for Tri-Sprintec that change the supplier mapping?
Supplier mapping can differ by NDC because labelers can vary by pack configuration and dosage presentation.

3) Do wholesalers count as “suppliers” for Tri-Sprintec in sourcing decisions?
Wholesalers are distribution nodes. Regulatory and manufacturing supply rests with the FDA labeler and manufacturing sites.

4) What drives Tri-Sprintec shortages: API or packaging?
For COCs, packaging capacity and validated line throughput can be a major constraint, even when API supply is adequate.

5) Does Orange Book patent status determine which manufacturers can legally supply Tri-Sprintec?
Patent and exclusivity status shape lawful FDA marketing entry for generics and AB-rated equivalents, affecting which manufacturers can supply the market.

References (APA)

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
2. FDA Labeling for Tri-Sprintec (package insert/label). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/