Suppliers and packagers for symfi

symfi

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Labs Ltd	SYMFI	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022142	NDA	Viatris Specialty LLC	49502-475-93	1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2018-04-25

Suppliers and packagers for symfi

Last updated: May 30, 2026

SYMFI suppliers: Who manufactures and supplies this oseltamivir?

Executive summary: SYMFI is a branded fixed-dose combination product. Suppliers are determined by (1) the FDA label-listed manufacturers and (2) Orange Book–listed NDA holders and patent-prosecution assignees that drive commercial supply. No complete supplier list can be produced from the information provided.

What companies supply SYMFI (manufacturer of record, label-listed suppliers)?

Featured snippet answer: SYMFI supply is controlled by the FDA label “Manufactured for” and “Manufactured by” entries and the NDA holder/labeler of record, with distribution typically performed by the labeler or contracted logistics partners.

Key supplier identifiers that define “who supplies”

• Manufacturing site(s): the “Manufactured by” block in the prescribing information.
• Labeler of record / NDA holder: the company responsible for supply obligations and FDA submissions.
• Repackagers / secondary packers: if listed on-country (packaging label text).
• Authorized distributors: typically not listed in the FDA label, but may appear in tender documents and commercial catalogs.

What is the Orange Book status of SYMFI and how does it map to suppliers?

Featured snippet answer: Orange Book coverage is driven by the drug’s NDA and any listed patents (drug substance, formulations, methods of use, packaging, and manufacturing). Orange Book listing helps identify the commercial rights holder, which is typically the principal supplier.

How Orange Book listings translate into supplier control

• NDA holder often aligns with the primary commercial manufacturer.
• Assignees for formulation and method patents can point to the technology origin even when supply is outsourced.
• Therapeutic equivalents can change supplier economics if an AB-rated generic exists.

Which patents protect SYMFI and do they affect supply relationships?

Featured snippet answer: Formulation and manufacturing patents can constrain generic substitution and can influence which contract manufacturers are licensed or permitted to produce launch materials.

Patent estate categories that commonly map to supplier selection

• Drug substance synthesis/process patents
• Fixed-dose combination formulation patents (blend, granulation, compression)
• Solid oral dosage manufacturing method patents (content uniformity, dissolution specs)
• Packaging patents (less common for oral tablets/capsules but can occur)

When does SYMFI lose exclusivity for generic entry and how does that change suppliers?

Featured snippet answer: Generic entry timing depends on the NDA exclusivity window and any listed Orange Book patents. The first challengers typically trigger supply reallocation to lower-cost manufacturers post-expiration/settlement.

Exclusivity timing levers

• NCE/3-year exclusivity
• Patent expiration
• Paragraph IV litigation timelines and settlements
• Pediatric exclusivity extensions
• Orphan drug or other specific exclusivities (only if applicable)

Are there Paragraph IV challenges to SYMFI that reveal supplier competitors?

Featured snippet answer: Paragraph IV filings identify the generic sponsor(s) and the expected launch date. This often shows which manufacturers are underwriting the generic product’s supply.

Competitive intelligence that typically comes from Paragraph IV

• Sponsor names (ANDA filers)
• Listed patents targeted
• Proposed strengths/dosage forms
• Launch coordination and potential co-marketing entities

What generic entry risks exist for SYMFI and which suppliers might compete?

Featured snippet answer: Generic risk is highest when:

• Orange Book patents are near expiration or invalidated
• The product has simple solid oral manufacturing (lower operational complexity)
• There are existing ANDA approvals or approved generics

Supplier dynamics

• Incumbent supplier often shifts to defense contracts or relaunch strategies.
• Generic competitors usually contract manufacturing with scale players once bioequivalence and stability are locked.

How does SYMFI compare with other branded fixed-dose combinations in supplier structure?

Featured snippet answer: Fixed-dose combination products commonly rely on:

• One or two primary manufacturing sites for bulk supply
• Contract manufacturers for intermediate steps (API, blend, tablet compression)
• Central packaging under the labeler’s quality system

What to look for in label text across the category

• “Manufactured for” vs “Manufactured by”
• Multiple NDCs with different manufacturing sites
• Transfer of manufacturing during lifecycle changes

What is the FDA regulatory status of SYMFI (NDA/ANDA status) relevant to suppliers?

Featured snippet answer: The FDA status that matters for suppliers is whether:

• The NDA is active with current-year manufacturing and distribution
• Any ANDAs have FDA-approved labeling and manufacturing sites
• The product is discontinued or supply-constrained (label updates)

Regulatory artifacts that identify suppliers

• FDA label revision history and manufacturing site changes
• OOS/recall announcements (if any) tied to manufacturing facilities
• FDA inspection signals that change which contract manufacturers remain active

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Key Takeaways

• Supplier identification for SYMFI requires the FDA label “Manufactured by/for” and labeler of record mapping, then cross-checking with Orange Book NDA/patent listings.
• The information provided is insufficient to produce a verified list of specific supplier companies, manufacturing sites, and distribution partners for SYMFI.

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FAQs

1. Where can I find the manufacturer of record for SYMFI on the prescribing information?
2. Does the NDA holder for SYMFI always produce the product in-house, or use contract manufacturers?
3. How do Orange Book patent assignees for SYMFI correlate with commercial supply and licensing?
4. What signals in FDA label revisions indicate a change in SYMFI manufacturing sites?
5. If a generic for SYMFI is approved, how do manufacturing locations typically change versus the branded product?