opill: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-01	1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-03	3 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-04	4 BLISTER PACK in 1 PACKAGE (0113-8101-04) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-06	6 BLISTER PACK in 1 CARTON (0113-8101-06) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	Redpharm Drug	67296-1938-2	1 BLISTER PACK in 1 CARTON (67296-1938-2) / 28 TABLET in 1 BLISTER PACK	2024-03-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Opill is a branded oral contraceptive containing levonorgestrel 1.5 mg. The U.S. commercial supply chain is led by the manufacturer of record that holds the FDA-approved NDA and supplies finished product to wholesale distributors and retail channels. The supplier set for Opill in practice is determined by (1) the FDA label’s “Manufactured for” / “Distributed by” statements, (2) Orange Book listed drug-product sponsors for the NDA, and (3) public procurement and distribution disclosures tied to the OTC distribution network.

The key point for business planning: the relevant “suppliers” are not limited to active-ingredient makers. The operational bottleneck for generic entry risk, regulatory continuity, and cost is the finished-dose manufacturer and fill-finish packager that can support scale while maintaining regulatory controls for a fixed-dose levonorgestrel tablet.

Who supplies Opill levonorgestrel 1.5 mg to pharmacies and wholesalers?

Direct suppliers in the commercial chain

NDA/label manufacturer of finished Opill tablets (the firm identified on the carton/label as the manufacturer or “manufactured for” entity).
NDA/label distributor (the firm identified as “distributed by” on the label).
Wholesale distributors that move product from the manufacturer/distributor into retail drug chains, mass retailers, and online pharmacy channels.
Packagers involved in tablet packaging and imprinting, blistering, bottle fill, and secondary packaging (often separate legal entities even when the same sponsor controls quality).

What “supplier” means for sourcing

Regulatory supplier: the finished-product manufacturer on the FDA labeling for Opill.
Supply-chain supplier: the entity that ships product under distribution agreements to wholesalers and retail.
Manufacturing input suppliers: API (levonorgestrel) producers and excipient suppliers.
Packaging suppliers: packaging components and operations that can constrain scale.

What does the Opill FDA label identify as manufacturer and distributor?

For procurement, the actionable starting point is the label’s imprint lines:

“Manufactured for” (finished-product sponsor)
“Distributed by” (U.S. distribution entity)
The storage/handling and lot traceability lines on carton labels often show the company address for the finished product entity.

Those label identifiers determine which entities are directly accountable in FDA compliance terms and in product recall coordination.

Are Opill API suppliers listed publicly?

API suppliers are typically not named on the OTC label. They may appear in:

NDA chemistry, manufacturing, and controls (CMC) filings (not fully public)
supplier qualifications in inspections (not publicly consolidated)
occasional procurement announcements or import/export records

For supplier due diligence, API sources are usually verified via vendor audits, supplier qualification packages, and change-control documentation rather than label review.

What companies manufacture Opill (levonorgestrel 1.5 mg tablets) in the U.S.?

Short answer

The manufacturer(s) of record for Opill are the entities named on the approved product labeling tied to the NDA sponsor.

How to map “manufacturing companies” for sourcing

Use the Orange Book “Application Holder” and manufacturer listings for the Opill NDA to identify the responsible sponsor and associated drug-product manufacturer entries.
Cross-check with the U.S. label for “manufactured for” and lot traceability addresses.

Commercial implications

Multi-site manufacturing often exists for OTC rollouts, but the “manufacturer of record” is what matters for:
- consistent labeling and batch release
- recall risk allocation
- supply continuity if one site is disrupted

What is the Orange Book status of Opill and who is listed as the applicant?

Orange Book listings for Opill identify:

NDA number
application holder (applicant/sponsor)
dosage form (tablet) and strength (1.5 mg)
patent and exclusivity entries tied to that NDA product

Orange Book does not list every upstream API or packaging supplier. It does identify the regulated drug-product sponsor and related patent estate, which often correlates with the finished-dose manufacturer’s compliance responsibility.

What excipient and packaging suppliers support Opill tablet supply?

Where sourcing constraints usually occur

Tablets require a validated blend process and compression system that controls:
- uniformity of dose for levonorgestrel 1.5 mg
- impurity profile
- moisture uptake and stability
OTC packaging requires:
- tamper-evident bottle or blister systems
- child-resistant compliance where applicable by market practice and regulations
- shelf-life packaging validation (shelf stability under humidity and temperature)

Who the suppliers tend to be

Excipients are commonly supplied by large ingredient manufacturers and distributors, including:
- cellulose-based binders/disintegrants
- lubricants
- film coatings (if any)
Packaging suppliers are typically component and packaging material companies plus packagers operating under contract manufacturing arrangements.

Actionable sourcing lens

For supply continuity and substitution planning, companies verify:
- packaging material change control history
- compatibility with stability studies
- lead times for blister film or bottle components
- availability of tablet press capacity under the sponsor’s GMP regime

How many Opill manufacturing sites supply the U.S. market?

There is no single consolidated public count of all manufacturing sites globally. The operational reality is:

Opill supply can involve one primary finished-dose site plus one or more secondary packaging sites.
Additional sites may be added under CMC supplements to expand capacity during distribution scaling.

What you can verify quickly

Compare lot number format and manufacturer addresses printed on different lots over time.
Cross-check label “manufactured for” addresses across distribution periods.

How does supplier concentration affect generic and biosimilar entry risk for Opill?

Opill is a small-molecule OTC contraceptive

“Biosimilar risk” is not relevant because levonorgestrel is a small-molecule drug.
The relevant competitive threat is generic small-molecule entry via Abbreviated New Drug Application (ANDA) pathways and, if applicable, challenges to patents listed for the NDA.

Supplier concentration matters because

If supply relies on a single finished-dose site, the sponsor’s ability to maintain market stock can be sensitive to site disruptions.
That can influence:
- retail availability
- wholesale inventory levels
- pricing power and promotional support
- timing and feasibility of generic substitution at the pharmacy counter

What patent estate and exclusivity terms influence supply negotiations and licensing for Opill?

Supplier decisions often tie to the patent and exclusivity environment because:

A robust patent estate can support continued branded market protection.
Licensing and settlement agreements can affect:
- manufacturing for “authorized generics”
- supply agreements with alternative packagers
- distribution commitments during exclusivity windows

Opill’s legal status hinges on:

Orange Book listed patents for the NDA product
FDA exclusivity grants tied to the application

The supplier set is indirectly shaped by these legal constraints because challengers often negotiate only once a product is closer to entry readiness.

Where does Opill appear in FDA Orange Book, and why does that matter for suppliers?

For supplier mapping, Orange Book matters because it identifies the responsible application holder and patents for the exact drug product:

tablet dosage form
levonorgestrel 1.5 mg strength
associated patents and exclusivity entries

That is the regulated anchor point for:

any ANDA or patent challenge posture
shelf-life and formulation identity expectations
labeling and manufacturing comparability

Competitive landscape: Who are the supplier alternatives if Opill supply is constrained?

If Opill supply tightens, alternatives at the retail level usually fall into two buckets:

Other levonorgestrel emergency contraception brands (OTC) or versions marketed under different brand names.
Therapeutic alternatives (including other emergency contraception mechanisms, depending on approved indications and product availability).

From an R&D and procurement standpoint, the best “supplier alternatives” are not necessarily other brands, but other suppliers able to manufacture levonorgestrel tablets to GMP standards at scale, which is verified through:

regulatory standing
CMC capacity for the specific dosage form
label and packaging compliance

Key Takeaways

The most actionable “suppliers” for Opill are the finished-dose manufacturer and U.S. distributor named on the FDA-approved labeling tied to the Opill NDA and Orange Book listing.
Upstream API suppliers and excipient/packaging vendors are usually not named publicly; supplier verification is done through labeling, Orange Book sponsor mapping, and supplier qualification documentation.
Supplier concentration affects operational continuity, which influences retail availability and can affect the pace and feasibility of competitive substitution during periods of tight supply.

FAQs

1) What information identifies Opill’s finished-dose manufacturer on-pack?
The “Manufactured for” and “Distributed by” lines on the carton/label, plus the lot traceability imprint.

2) Are levonorgestrel API suppliers listed for Opill in the U.S. label?
Typically no; API suppliers are generally not identified on OTC packaging.

3) Does Orange Book list all packaging and contract manufacturers for Opill?
No. Orange Book lists the application holder and regulated drug-product-related information; it may not enumerate all packaging operations.

4) How does supplier continuity affect emergency contraception inventory?
Finished-dose supply and packaging capacity drive replenishment lead times, which affects wholesale fill rates and pharmacy shelf availability.

5) Is biosimilar competition relevant to Opill supplier planning?
No. Opill is a small-molecule drug; competition is about generics/ANDAs and other approved emergency contraception products.

References (APA)

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
U.S. Food and Drug Administration. Drug Label Information (DailyMed). https://dailymed.nlm.nih.gov/

Suppliers and packagers for opill

opill

Suppliers for Opill (levonorgestrel 1.5 mg OTC contraceptive pill): Who manufactures, ships, and supplies the U.S. market