Last updated: June 8, 2026
PLAN B ONE-STEP is supplied in the US by a small set of branded-generic contract manufacturers coordinated through Teva Pharmaceuticals and its downstream affiliates. The active ingredient is levonorgestrel (LNG), typically produced via specialized steroid API supply networks, while finished-dose manufacturing is performed by GMP dosage-form plants under brand-owner direction.
Who are the main suppliers for Plan B One-Step in the US?
Answer: Teva Pharmaceuticals is the brand owner for PLAN B ONE-STEP in the US; finished-dose supply is sourced from Teva-managed manufacturing partners and/or Teva-operated GMP facilities. API supply is sourced from specialized levonorgestrel API producers within the steroid API supply chain.
What role does Teva play in Plan B One-Step supply?
Teva controls key supply-chain levers that determine “who the supplier is” in practice:
- Finished-dose release: Teva batch control and distribution through licensed distribution channels in the US.
- Contract manufacturing oversight: Teva’s packaging, labeling, and distribution network for the branded product.
- Regulatory ownership: US FDA listing ownership for the finished dosage form and associated manufacturing site listings.
Who provides the levonorgestrel API?
Levonorgestrel (LNG) is a steroid active that is not typically manufactured by large commodity API suppliers without steroid capability. API suppliers are usually limited to specialized steroid API manufacturers that can support:
- multi-step synthesis with consistent stereochemical purity,
- solvent recovery and controlled impurity profiles,
- DMF or other disclosure pathways to meet FDA expectations for starting material and process controls.
What finished-dose manufacturers make Plan B One-Step tablets?
Answer: The finished-dose manufacturer is identified on the product labeling and FDA manufacturing-site listings. For the branded US product, manufacturing is done at GMP facilities under Teva’s product control system.
How to identify the current finished-dose site
For a given US lot, the most reliable supplier identification comes from:
- the package labeling “Manufactured for/Distributed by” language,
- the FDA drug product listing and its associated “Applicant/Manufacturer” and “Labeler” structure,
- the specific dosage form entry for PLAN B ONE-STEP (levonorgestrel 1.5 mg) in the Orange Book and FDA listing data.
What dosage form-specific supply constraints apply?
PLAN B ONE-STEP is a single-dose tablet presentation. That creates practical manufacturing constraints:
- tablet compression and uniformity controls at low-mass dosing,
- moisture control during packaging,
- stability management for levonorgestrel in the finished blend and finished tablet.
What companies supply Plan B One-Step as generics or authorized alternatives?
Answer: The branded product faces branded and generic alternatives, and these products are supplied by multiple finished-dose manufacturers. Authorized or approved alternatives often use different labelers/manufacturers even when the same API is used.
How supplier switching happens during shortages
During constrained supply periods, the supply chain typically shifts by:
- substituting equivalent GMP plants under the same NDA/ANDA umbrella,
- adjusting packaging line assignments while keeping the same API source and approved formulation,
- sourcing tablets from additional approved manufacturing sites listed under the product.
How do API suppliers for levonorgestrel differ from finished-dose suppliers?
Answer: API suppliers are specialized steroid manufacturers; finished-dose suppliers are tablet-GMP plants with capability for low-dose uniformity and packaging controls.
What this means for “supplier risk”
Supplier risk for Plan B One-Step splits into two layers:
- API bottlenecks: steroid intermediate availability, reactor capacity, impurity control, and API crystallization capacity.
- Finished-dose bottlenecks: tablet compression line capacity, blending uniformity, and packaging line throughput.
Which documents list Plan B One-Step manufacturing sites and labelers?
Answer: US FDA product listings and related FDA datasets are the primary artifacts that list the manufacturer and labeler(s) for PLAN B ONE-STEP.
What to check (data fields that map to “suppliers”)
For each current branded product listing, focus on:
- Labeler: who is responsible for the product entry.
- Manufacturer: the GMP site(s) tied to manufacturing and release.
- Dosage form and strength: to avoid mixing with other levonorgestrel products (for example, different strengths or multi-tablet presentations).
What does the Plan B One-Step supplier chain look like end-to-end?
Answer: A typical end-to-end chain is:
- Levonorgestrel API synthesis (specialized steroid API supplier network).
- Drug product formulation and tablet manufacturing (GMP tablet plant).
- Packaging (blistering or bottle filling as per labeling configuration).
- Labeling and distribution under the brand-owner control (Teva for PLAN B ONE-STEP).
What supplier landscape matters most for availability and procurement?
Answer: The procurement-critical suppliers are:
- the finished-dose GMP site(s) releasing lots into the US market,
- the GMP packaging line(s),
- the API supplier(s) capable of sustaining volume and meeting impurity specifications.
How to use this for sourcing and contingency planning
Procurement and contracting typically plan around:
- multi-site drug product supply (alternate GMP plants),
- continuity of API supply via qualified steroid API vendors,
- safety stock and lot allocation policies during constrained periods.
Key Takeaways
- Teva is the brand owner for PLAN B ONE-STEP in the US and controls the product supply through its regulatory and distribution system.
- Finished-dose suppliers are identified via FDA listing/manufacturer-site data and product labeling for each lot.
- API suppliers are specialized steroid manufacturers producing levonorgestrel, distinct from finished-dose tablet plants.
- Availability risk is layered: API constraints and finished-dose/packaging line constraints.
FAQs
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How can I identify the manufacturer of a specific Plan B ONE-STEP lot?
Check the lot’s package labeling and the corresponding FDA drug product listing/manufacturer-site entries for the exact product strength and dosage form.
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Are Plan B ONE-STEP tablets made by the same companies that make generic levonorgestrel tablets?
Not necessarily. Brand and generic labelers can use different GMP tablet and packaging sites even if the API is the same.
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What determines supplier continuity for levonorgestrel API?
Steroid intermediate availability, capacity in API synthesis and purification, impurity profile control, and qualification under regulatory frameworks.
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What manufacturing step is most likely to cause supply disruptions?
Often the narrowest capacity point is API availability or tablet compression and packaging line throughput for the exact presentation.
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Does PLAN B ONE-STEP use a single manufacturer or multiple GMP sites?
Branded product programs commonly support more than one approved site, depending on regulatory submissions and supply needs.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. United States Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Drug Registration and Listing System (DRLS) Public Data. United States Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/drls/
- FDA. Labeling and prescribing information repositories for approved products. United States Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
