Suppliers and packagers for SOLOSEC

SOLOSEC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363	NDA	Evofem Inc.	69751-400-01	1 PACKET in 1 CARTON (69751-400-01) / 2 g in 1 PACKET	2018-05-31

SOLOSEC (secnidazole) suppliers: Who manufactures, supplies API, and provides dosage-form outsourcing for the US and key markets

Last updated: May 30, 2026

SOLOSEC is secnidazole, an oral nitroimidazole indicated for bacterial vaginosis. Supplier coverage depends on the market and the dosage form. In the US, SOLOSEC is distributed under Bausch Health’s brand ownership and sourced through commercial manufacturing and distribution channels listed on regulatory filings and product labeling.

What is SOLOSEC and how does supply chain complexity affect “suppliers”?
SOLOSEC is the trade name for secnidazole. Supply chain mapping typically splits into: (1) API manufacturer(s), (2) finished-dose manufacturer(s) for the tablets, and (3) branded product distributor(s) for the labeled market.

Which finished-dose suppliers are tied to US SOLOSEC product labeling?
US product labeling identifies the labeled manufacturer/distributor for SOLOSEC and is the anchor for finished-dose supplier identification. The practical “supplier” set for procurement and partner due diligence is usually limited to the named labeler plus the contract manufacturing organizations (CMOs) supporting tablet production and packaging.

What controls the “API supplier” list for secnidazole?
API supply for secnidazole is less visible in brand-facing documents than finished-dose manufacturing. API suppliers are typically identified through:

• Drug Master File (DMF) references in FDA submissions
• cGMP facility listings in regulatory review documents
• Imports of API into finished-dose manufacturing sites
• Commercial availability through specialty chemical distributors

If you are mapping supplier risk for qualification or dual-sourcing, the key is to identify both the finished-dose manufacturing site and the API source site feeding that site.

SOLOSEC supplier landscape: which company owns the brand and who supplies finished-dose product?
In the US, SOLOSEC is marketed by Bausch Health as brand owner, with distribution and product supply executed through labeler and manufacturing arrangements described in FDA labeling. The usable supplier list for commercial planning is therefore:

• Brand labeler/distributor for the US market (Bausch Health entity shown on labeling)
• Finished-dose manufacturer(s) shown on the SOLOSEC label and associated regulatory product pages
• Packaging and testing sites where listed on label/CMC documentation

H2: What companies supply SOLOSEC tablets (secnidazole) and where are they manufactured?
SOLOSEC is a solid oral dosage form. Tablet/packaging supply is typically handled by commercial pharmaceutical manufacturing sites, and the exact facility names are captured in label and FDA product listings.

Finished-dose manufacturer and packaging identifiers to extract

For SOLOSEC, the supplier set you want for procurement and quality agreements usually includes:

• Tablet manufacturing site listed on labeling
• Secondary packager/site listed on labeling (if separate)
• Quality control testing site (if disclosed in label or CMC summaries)

How to treat “supplier” terms in sourcing due diligence

• “Manufacturer” on the label maps to the finished-dose site for the labeled product.
• “Distributor” maps to the US market supply chain point-of-contact.
• “Supplier” in an RFP context should be interpreted as the entity responsible for supply under cGMP manufacturing and distribution, not only the brand owner.

H2: Who supplies secnidazole API used to make SOLOSEC?
Secnidazole API is produced by specialty chemical manufacturers and then supplied to tablet formers/packagers via commercial chemical supply chains or through integration into the finished-dose CMO’s qualification package.

API sourcing patterns for nitroimidazole products

Typical API sourcing patterns include:

• Direct API procurement by a CMO that manufactures secnidazole tablets under contract
• API procurement by the finished-dose manufacturer from an upstream API supplier with DMF support
• Multi-source qualification (if regulatory submissions list multiple manufacturing sites)

What to use as the highest-signal documents

The highest-signal source for API supplier identification is DMF-linked CMC information tied to the approved NDA or associated supplements, plus any site-validated manufacturing statements in regulatory reviews and annual reports.

H2: Which API manufacturers produce secnidazole for branded products like SOLOSEC?
Nitroimidazole APIs are generally supplied by multiple chemical manufacturers across Europe, India, and China, but the correct mapping to SOLOSEC requires tying the API supplier to the finished-dose manufacturing sites actually used for the US product.

Commercial relevance: API supplier swaps can invalidate pre-submitted impurity profiles and polymorph/particle-size specifications. Procurement teams treat “API supplier change” as a regulatory and quality change control event unless the finished-dose site’s validated API source set already includes that supplier.

H2: What is the Orange Book status of SOLOSEC and what does it imply for supplier availability?
SOLOSEC’s exclusivity status influences generic manufacturing entrants, which in turn affects how many alternative finished-dose suppliers are available. If exclusivity still holds and there are no authorized generics, the branded supplier set remains narrower.

What to extract for supplier forecasting

• Whether ANDA filers exist and have entered the market
• Whether any approved generic secnidazole products have FDA marketing status
• Whether any authorized generic program exists for the product

H2: Are there ANDA or generic suppliers for secnidazole tablets competing with SOLOSEC?
When generics exist, “suppliers” expand to include new CMO and packaging facilities tied to ANDA-approved products. In an RFP or litigation context, competing product listings identify alternative manufacturing sites and labeling entities.

Generic entry risks for supplier planning

• If a generic launch is imminent, procurement can dual-source across labelers and manufacturers
• If no generic is approved, supply constraints are more likely to remain concentrated in the brand’s manufacturing and distribution channel

H2: What formulation and manufacturing patents affect SOLOSEC supplier qualification?
Patents typically do not block contract manufacturing directly, but they can affect:

• whether an ANDA can use certain intermediate steps or specific particle engineering approaches
• whether process changes require comparability bridging
• whether method-of-use claims constrain labeling claims and thus development scope

Manufacturing/IP barriers that matter to sourcing

• Process-specific control strategies (granulation, compression, disintegration) can create proprietary know-how barriers
• API impurity specification limits can force the finished-dose site to accept only qualified upstream sources
• Packaging and stability know-how can affect shelf-life support and incoming release testing

H2: Which SOLOSEC supply chain vendors matter for import and distribution in the US?
For the US, the relevant vendor network for a procurement program usually includes:

• Authorized distributor(s) for the labeled product
• Cold chain is not applicable (solid oral tablets), but temperature-controlled transport can still be relevant for stability-sensitive packaging
• Customs broker and logistics service for import lanes if the product or components are sourced internationally

Commercial insight: for solid oral nitroimidazole products, the biggest practical supply constraints tend to be batch scheduling at the finished-dose CMO and regulatory release capacity, not cold-chain logistics.

SOLOSEC supplier diligence checklist (what to validate in contracts and quality agreements)

• Named finished-dose manufacturer and packaging site(s) on SOLOSEC labeling
• cGMP compliance status for the manufacturing sites
• Incoming API testing and release specifications tied to the approved product’s quality attributes
• Stability program and change control history for API source, tablet formulation, and packaging
• Audit rights, batch record ownership, and deviation handling timelines
• Regulatory filing traceability to the NDA approval’s CMC sections

Key Takeaways

• SOLOSEC supply in the US is anchored by the labeler/distributor named on product labeling and the finished-dose manufacturer(s) tied to that labeled product.
• API suppliers for secnidazole are less directly visible and must be mapped through DMF-linked CMC and site qualification documentation tied to the finished-dose manufacturing sites actually producing SOLOSEC for the market.
• Supplier availability and alternative sourcing expand mainly when ANDA or authorized generic supply exists; otherwise, supplier concentration remains with the brand’s manufacturing and distribution channels.

FAQs

1) Who is the labeler/distributor for SOLOSEC in the United States?
The labeler/distributor is the company entity shown on the SOLOSEC US product labeling, which is the primary anchor for finished-dose supply sourcing.

2) How can procurement teams identify the secnidazole API supplier for SOLOSEC?
By tracing upstream API source qualification through DMF-referenced CMC content tied to the NDA and the specific finished-dose manufacturing site producing SOLOSEC.

3) Do SOLOSEC manufacturing process patents limit generic supplier manufacturing?
They can limit generic pathways if specific process controls, intermediates, or quality-critical steps are claimed, but they do not automatically block contract manufacturing.

4) What documents matter most for supplier qualification for SOLOSEC tablets?
NDA-linked CMC summaries, label-identified manufacturing sites, DMF references, stability protocol evidence, and batch release specifications.

5) Are there alternative secnidazole tablet suppliers to SOLOSEC in the US market?
Only if ANDA or authorized generic products have FDA approval and commercial availability; otherwise the branded supplier chain remains the dominant source.

References (APA)

1. FDA. (n.d.). Drug approvals and product information for secnidazole (SOLOSEC). U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. FDA. (n.d.). DailyMed. U.S. National Library of Medicine.