Last updated: June 17, 2026
JUNEL FE 1.5/30 Suppliers: Active Ingredient, Manufacturing, and Labeler/Distributor Map
Executive summary: JUNEL FE 1.5/30 is an oral combined hormonal contraceptive (ethinyl estradiol 1.5 mcg + norethindrone acetate 30 mcg) marketed by Allergan/AbbVie under the Actavis/Forest/Teva era brands commonly seen in distributor channels. Key upstream “supplier” inputs typically split into (1) API manufacturers for norethindrone acetate and ethinyl estradiol, (2) tablet packaging sites for the blister/carton presentation, and (3) the labeler/distributor listed on FDA labeling. Without the specific FDA labeler record and Orange Book/NDC linkage for the exact strength and package configuration, a complete, defensible supplier list cannot be produced.
What suppliers manufacture JUNEL FE 1.5/30 tablets (labeler, NDC, blister site)?
Answer: JUNEL FE 1.5/30’s “supplier” chain depends on the specific NDC (package size and presentation change manufacturing and packaging records). The FDA’s drug product record ties the commercial product to a labeler name, and the labeler determines which contract manufacturers and packaging partners appear in submission histories.
What to map first: labeler vs. actual manufacturing site
For oral solids like JUNEL FE 1.5/30, three entities commonly appear in public records:
- Labeler (listed as applicant/marketing authorization holder on FDA labeling and NDC directory)
- Manufacturer of record (tablet/capsule manufacturing site)
- Packaging/distribution (blistering, secondary packaging, distribution warehouse)
A definitive supplier list requires the exact NDC record used by the current marketed pack.
Which companies supply ethinyl estradiol API and norethindrone acetate API for JUNEL FE 1.5/30?
Answer: API supply for steroidal contraceptives is concentrated among a small set of global steroid API firms, but the exact upstream supplier for JUNEL FE 1.5/30 is not uniquely identifiable from strength alone. The supplier must be traced through:
- FDA drug application manufacturing information (where disclosed)
- DMF-linked letters of authorization (not reliably public at the firm level)
- supplier statements embedded in regulatory submissions (often redacted)
API categories that drive supplier selection
- Steroid synthesis intermediates (e.g., estrone/ethinylation routes and acetate esterification for norethindrone acetate)
- Crystallization control (polymorph and particle size for tableting)
- Analytical release testing (impurities for ethinyl estradiol and acetate ester impurities)
What contract manufacturers produce JUNEL FE 1.5/30 oral contraceptive tablets?
Answer: JUNEL FE 1.5/30 is produced in oral solid dosage forms (tablets). The contract manufacturer is selected by the labeler and is often different from the API producer.
Manufacturing steps that affect which suppliers qualify
- Granulation and compression of low-dose steroid blends
- Uniformity testing at microgram to low-milligram levels
- Tablet hardness and dissolution consistency across lots
- Blister packing and calendar-pack printing control (critical for cycle dosing)
Who supplies the blister packaging and distribution system for JUNEL FE 1.5/30?
Answer: Blister packaging suppliers are typically regional packaging contractors. They supply:
- Form-fill-finish blister lines (Alu/Al blister systems)
- Carton labeling and “day” schedule printing alignment
- Serialization and distribution logistics (where applicable)
Why package configuration changes the packaging supplier
Different package sizes (28-day calendar packs vary by country/market) can route through different blister lines and secondary packaging contractors, even when the tablet is made at the same manufacturing site.
How does JUNEL FE 1.5/30 compare with other Junel Fe strengths (same suppliers vs different)?
Answer: Junel Fe strengths frequently share:
- The same labeler brand owner and distribution channel
- The same family of oral contraceptive formulation suppliers
- Common packaging contractors for blister calendar packs
Supplier identity can still change when:
- The tablet weight changes enough to require different equipment or presses
- The stability profile forces different excipient vendors
- The product moves to a different contracted site during tech transfer
What Orange Book listing and FDA status applies to JUNEL FE 1.5/30, and does it show suppliers?
Answer: The Orange Book and FDA product record show the listed drug and sometimes the application holder. They do not always expose upstream API and contract manufacturing suppliers in a way that supports a complete “who supplies the product” list without the exact NDC-to-record mapping.
What to extract from FDA product records (when mapped to NDC)
- Applicant/labeler name
- Dosage form and route
- Marketing status
- Application type (NDA vs ANDA)
- Patent/EX exclusivity linkage (relevant for biosimilar or generic entry risk)
Commercial supplier implications: what supplier concentration means for supply risk?
Answer: For low-dose steroid oral contraceptives, supply risk concentrates in:
- Steroid API availability
- Tableting capacity for micro-dose uniformity
- Specialized blister calendar-pack printing throughput
A supplier outage at any one of these steps can constrain availability even when shelf inventory exists.
Key Takeaways
- JUNEL FE 1.5/30 “suppliers” break into labeler, tablet manufacturer, API producer, and blister/secondary packaging contractors.
- A precise supplier list requires the exact FDA/NDC record for the marketed package because supplier identity can change across presentations.
- Upstream steroid API supply is handled by specialized API firms, but the specific API source for JUNEL FE 1.5/30 must be traced through FDA submission and NDC-linked product records.
FAQs
- How do I find the correct NDC for JUNEL FE 1.5/30 to identify the labeler and manufacturer of record?
- Do the same API suppliers make norethindrone acetate and ethinyl estradiol for all Junel Fe strengths?
- Which part of the supply chain is most sensitive for low-dose ethinyl estradiol tablets: API, tableting, or blister packaging?
- Can Orange Book listings reveal the tablet manufacturer contract site for JUNEL FE 1.5/30?
- Do generic and authorized generic versions of Junel Fe share the same suppliers or only the formulation/labeler?
References (APA)
No specific FDA Orange Book record, NDC directory entry, or labeling page for JUNEL FE 1.5/30 was provided in the prompt, so no sources can be cited to support a definitive supplier list.
