Suppliers and packagers for LORYNA

LORYNA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xiromed	LORYNA	drospirenone; ethinyl estradiol	TABLET;ORAL	079221	ANDA	Bryant Ranch Prepack	63629-2336-1	3 CARTON in 1 CARTON (63629-2336-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK	2018-10-09
Xiromed	LORYNA	drospirenone; ethinyl estradiol	TABLET;ORAL	079221	ANDA	Xiromed, LLC.	70700-114-85	3 BLISTER PACK in 1 CARTON (70700-114-85) / 1 KIT in 1 BLISTER PACK	2022-06-09

Loryna Suppliers: Which Companies Provide Active Ingredients, Finished Dosage, and Manufacturing Services for Bayer’s Drospirenone/Ethinyl Estradiol Oral Contraceptive

Last updated: June 9, 2026

Loryna is a brand of an oral contraceptive containing drospirenone and ethinyl estradiol (EE). The supplier landscape is split between (1) upstream API and key intermediate suppliers, and (2) contract manufacturers that make and pack finished tablets, and (3) label holders and distributors that commercialize the product. For “suppliers,” the most defensible set for decision-making is the label holder, the listed manufacturing sites on FDA registrations/labels, and the parties assigned to Loryna patents and manufacturing supplements. If those are not identifiable for Loryna in the provided source set, a complete supplier map cannot be produced.

What companies supply Loryna (drospirenone and ethinyl estradiol) in finished-dose form?

Answer: The finished-dose supplier for Loryna is the company listed as the manufacturer on the U.S. package insert/label and the FDA-registered manufacturing sites associated with the NDA product. Supplier identification requires matching Loryna’s U.S. label/manufacturer statements to the relevant FDA registration entries and/or SPL product listings.

How do you identify the “finished drug” supplier for Loryna

For U.S. products, the highest-signal supplier identifiers are:

• NDA label “manufactured for / distributed by” statements.
• Drug listing and SPL data for product/manufacturer identifiers (teal points and “manufacturer” fields).
• FDA drug establishment registration entries tied to the specific NDCs for Loryna.

Common roles in the finished-dose supply chain

• Marketing authorization holder / sponsor (brand owner): controls product dossier and quality system oversight.
• Contract manufacturing organizations (CMOs): make tablets, perform compression, coating, packaging.
• Blending/granulation and tablet packaging vendors: often step in as separate manufacturing establishments.

Which suppliers make drospirenone and ethinyl estradiol APIs for Loryna?

Answer: Drospirenone and ethinyl estradiol API supply is typically sourced from specialized steroid API manufacturers. A complete supplier roster requires the specific Loryna API specifications and vendor declarations used in the NDA and manufacturing site registrations.

API sourcing characteristics for steroid oral contraceptives

• Highly regulated API manufacturing.
• Tight impurity profiles and polymorph/control strategy for steroid APIs.
• Multiple global vendors possible, with batch-by-batch qualification.

How to map Loryna’s API suppliers to the actual manufacturer

The operational method is:

1. Pull the Loryna NDC-specific manufacturing establishment records.
2. Crosswalk to drug substance manufacturing sites where API is produced or controlled.
3. Confirm the API is from the same named suppliers in quality agreements and DMF references (where publicly disclosed).

Without those specific FDA/label references for Loryna’s NDCs in the current source set, naming API suppliers would be speculative.

What is the Orange Book status of Loryna and how does it affect supplier identification?

Answer: Orange Book listings identify patent-protected aspects of Loryna and the reference NDA. Orange Book also helps link to the reference product, NDCs, and relevant application details used to find manufacturer and labeling statements.

What to look for in the Orange Book entry

• Reference listed drug (RLD) name: Loryna.
• Application number and dosage form/strength.
• Patent numbers tied to Loryna.
• Exclusivity that affects when generics enter and when manufacturing relationships may shift.

Which patent estate holders and assignees for Loryna indicate likely manufacturing or technology partners?

Answer: Patent assignees can sometimes correlate with formulation development and manufacturing process licensors. For Loryna, mapping the patent estate requires identifying the patent numbers listed against the Loryna Orange Book entry and reading the assignee/inventor blocks.

Why patent assignees matter for “supplier” decisions

• Formulation and process patents can identify the technology owner.
• Manufacturing method patents can indicate the process originator.
• In settlements or licensing agreements, assignees can become procurement and scale-up counterparties.

Who are the contract manufacturers for drospirenone/EE tablets like Loryna (global CMO landscape)?

Answer: The global CMO landscape for oral contraceptives includes large-scale solid oral dose players with steroid formulation capabilities. A Loryna-specific supplier list must be tied to Loryna’s NDC label manufacturing sites and FDA registrations.

Typical CMO functions for oral contraceptives

• Tablet core compression and coating.
• Packaging (blister/dispense unit packaging lines).
• Stability and ongoing process validation.

What generic entry risks exist for Loryna and how does that change sourcing suppliers?

Answer: Generic competition generally drives:

• more manufacturing site options,
• second-source packaging supply,
• and portfolio changes by brand holders.
  But the question requires knowing which Loryna patents and exclusivities constrain generic entry for drospirenone/EE combinations.

How patent timing translates into procurement leverage

• Near-expiry periods: brand holders sometimes dual-source APIs and intermediates.
• Post-settlement: manufacturing continuity can be negotiated with generic challengers or through licensing.

What formulations are protected for Loryna (drospirenone/EE) that impact manufacturing scale-up?

Answer: Formulation protection typically covers:

• tablet composition and excipient system,
• manufacturing process parameters,
• dissolution or release profile targets,
• and packaging stability. But a list must be pulled from Loryna’s formulation and process patents in the Orange Book.

Dosage forms and strengths that affect supplier fit

Oral contraceptive tablets can vary by:

• drospirenone strength and EE strength,
• tablet color/coating system,
• and phase schedule packaging (21-day/28-day regimen structures).

Loryna supplier list: where to get the authoritative “who makes it” names

Answer: The only reliable supplier list for Loryna in a regulatory and litigation context comes from:

• Loryna’s U.S. package insert/label manufacturer fields, and
• the FDA drug establishment registration and SPL manufacturer entries for the specific Loryna NDCs.

A complete, named supplier roster cannot be generated from the information provided in the prompt.

Key Takeaways

• “Suppliers for Loryna” breaks into finished-dose manufacturers and API suppliers; both require product-specific label/manufacturer and establishment registration data.
• Orange Book status ties Loryna to its application and patent estate, which is the foundation for identifying the correct RLD entry and then the manufacturing identifiers.
• A defensible, named supplier list requires the Loryna NDC-specific label manufacturing statement and FDA registration crosswalk; naming suppliers without those references would be speculative.

FAQs

1. How do I identify the actual contract manufacturer for a specific Loryna NDC?
2. Do Loryna’s Orange Book patents cover formulation and manufacturing methods or only composition?
3. Which FDA data sources provide the best evidence of Loryna manufacturing sites?
4. How do Loryna patent settlements typically affect manufacturing sourcing and dual sourcing timelines?
5. What differences exist in supplier requirements for drospirenone/EE tablet strengths and packaging formats?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drug Establishment Registration and Listing (DERP) and SPL product listings.
3. FDA. Approved Drug Products and Package Inserts for Loryna (drospirenone and ethinyl estradiol).