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Suppliers and packagers for PYLERA
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PYLERA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786 | NDA | H2-Pharma, LLC | 61269-380-12 | 10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK | 2023-10-01 |
| Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786 | NDA | H2-Pharma, LLC | 61269-381-12 | 10 BLISTER PACK in 1 BOX (61269-381-12) / 12 CAPSULE in 1 BLISTER PACK | 2025-08-18 |
| Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786 | NDA AUTHORIZED GENERIC | H2-Pharma, LLC | 61269-386-12 | 10 BLISTER PACK in 1 BOX (61269-386-12) / 12 CAPSULE in 1 BLISTER PACK | 2025-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ecutive summary
Pylera (bismuth subcitrate potassium/metronidazole/tetracycline) is marketed by Allergan (AbbVie) in the US. For “suppliers,” the most decision-relevant upstream inputs are (i) bismuth subcitrate potassium drug substance, (ii) metronidazole drug substance and metronidazole API intermediates, and (iii) tetracycline drug substance plus the formulation-grade tetracycline fractionation/filtration supply chain, with finished-dose manufacturing performed under contract or in-house depending on packaging site. Public disclosures for full supplier lists are limited; the most robust, litigation-grade way to map suppliers is via Orange Book manufacturing/labeler networks and by aligning those entities to DMF holders listed for bismuth subcitrate, metronidazole, and tetracycline (where FDA has made DMF accessable to applicants) and to the dosage form and packaging sites used for Pylera lots.
Key point for R&D, licensing, and litigation: treat “supplier” as a matrix (API DMF holder, drug substance manufacturer, dosage-form site, and packaging site). For Pylera, the labeler and manufacturing/packaging sites can be derived from FDA labeling and Orange Book-style manufacturing records, while API DMF holders require DMF-specific traceability that is not fully visible in public sources.
How many companies supply Pylera finished product and packaging in the US?
There is one marketed branded label (Pylera) but multiple manufacturing and packaging sites over time. The practical supplier count for commercial readiness is typically (a) one or more dosage-form manufacturers, (b) one or more packaging/repackaging sites, and (c) one supplier per drug substance stream (bismuth subcitrate potassium, metronidazole, tetracycline).
What is the branded labeler and who is responsible for Pylera in the US?
- Brand: Pylera
- US brand owner/labeler: Allergan (AbbVie) (historically tied to “Allergan” labeling for Pylera in FDA documentation and commercial distribution)
How do you identify the actual “suppliers” of Pylera in public data?
Use this hierarchy:
- Drug product manufacturing and packaging sites shown on Pylera FDA labeling and drug approval records (site-level “who made it”).
- Orange Book entry for Pylera to confirm the authorized drug product (and sometimes associated manufacturer details).
- DMF holder mapping by comparing Pylera applications’ referenced DMFs for each drug substance.
- Lot-level logistics via NDA annual report chemistry manufacturing controls references when accessible in litigation discovery.
What does the Orange Book status of Pylera show about suppliers?
Featured-snippet answer: Orange Book entries are used to map drug product identity and, in many cases, manufacturer and listed strength form; they do not typically publish full API supplier lists in a single line. The Orange Book is a starting point for drug product labeler and authorized product/manufacturer.
H2: What manufacturers make Pylera tablets in the US and where are they packaged?
Finished-dose “suppliers” are defined by dosage-form manufacturing and by packaging sites.
Which entities are typically involved across Pylera’s product chain?
- Dosage-form manufacturer for the fixed-dose combination capsules (bismuth subcitrate potassium + metronidazole + tetracycline)
- Primary packaging manufacturer (bottles/blisters)
- Secondary packaging/distribution site (depending on label distribution agreements)
What does FDA labeling usually list for Pylera?
- Manufacturer/packager name and address near “Manufactured for” / “Distributed by.”
- Strength-specific labeling details and lot/batch traceability.
How does Pylera’s fixed-dose combination affect supplier mapping?
Because the product contains three active components, each component may have different global supply routes:
- Bismuth subcitrate potassium: specialty inorganic/organometallic-like drug substance supply chain with limited qualified sources.
- Metronidazole: mature nitroimidazole supply chain with multiple global API suppliers.
- Tetracycline: antibiotic supply chain subject to antibiotic regulation and sourcing constraints.
H3: Are the suppliers different by strength or by packaging presentation?
Strengths can change over time, as can packaging (bottles vs cartons) and whether product is packaged by a contract packager versus directly by the dosage-form manufacturer. Supplier identity can therefore shift by lot even if the labeler stays constant.
H2: What suppliers provide bismuth subcitrate potassium for Pylera?
Featured-snippet answer: Bismuth subcitrate potassium is usually sourced from a limited number of API producers; supplier traceability depends on DMF references in Pylera’s NDA and any later manufacturing supplements.
What is the supplier bottleneck for bismuth subcitrate potassium?
- Active is a bismuth salt that requires tightly controlled heavy-metal impurity profiles and particle properties.
- Qualified supply typically sits with specialized inorganic/pharmaceutical-grade manufacturers.
How do you map bismuth subcitrate suppliers used in Pylera?
- Pull Pylera’s drug substance references from FDA chemistry/manufacturing sections in NDA records (publicly accessible in fragments through certain FDA portals and via labeling references).
- Identify DMF(s) for bismuth subcitrate potassium used by the NDA holders.
- Cross-walk DMF holder to commercial API suppliers (often by named DMF holder and/or by “manufacturer” listed on batch documentation in regulatory submissions).
H2: What suppliers provide metronidazole API for Pylera?
Featured-snippet answer: Metronidazole is widely manufactured, so supplier risk is mainly qualification, impurity control, and compliance history rather than raw access.
What parts of the supply chain matter for metronidazole?
- Metronidazole API production
- Nitroimidazole intermediates (depending on the manufacturer’s process route)
- Control of nitroimidazole genotoxic impurities and nitrosamine risk management aligned to ICH guidance
How do metronidazole suppliers show up in Pylera records?
- Through DMF holders for metronidazole drug substance referenced by the Pylera NDA
- Through “drug substance manufacturer” fields sometimes listed in CMC supplements
- Through audit/inspection outcomes tied to facilities in FDA inspection databases (facility-level)
H2: What suppliers provide tetracycline API for Pylera?
Featured-snippet answer: Tetracycline supply is constrained by antibiotic manufacturing compliance and antibiotic spectrum regulatory controls; supplier mapping depends on DMF holder and facility qualification.
What supplier variables drive tetracycline risk for Pylera formulation?
- Antibiotic API impurity profile (related substances and degradants)
- Particle size and flow properties for capsule fill uniformity
- GMP compliance history for antibiotic manufacturing
How do tetracycline suppliers show up in Pylera documentation?
- As DMF holders for tetracycline hydrochloride or tetracycline free base drug substance (Pylera uses tetracycline component in fixed-dose configuration, and the exact salt form used in the formulation must match the NDA CMC file)
- As dosage-form blend/component sourcing entries within CMC supplements
H2: Which contract manufacturers can supply Pylera and replicate its fixed-dose combination?
Featured-snippet answer: There is no single universal “Pylera contract manufacturer” because the product is a fixed-dose combination; contract manufacturing availability depends on (i) ability to handle antibiotics and bismuth salts in GMP, (ii) capsule blend uniformity capability, and (iii) regulatory readiness to support the exact formulation and batch record.
What technical capability is required to supply Pylera-like fixed-dose combination capsules?
- GMP-compliant capsule filling with blend uniformity validation
- Analytical controls for three actives in a single dosage form
- Stability-indicating methods suitable for bismuth-containing systems and nitroimidazole stability
- Cross-contamination controls for antibiotic actives
What are typical barriers for alternative suppliers?
- Formulation patents and process patents that can restrict making, using, or importing a generic fixed-dose combination
- Regulatory exclusivity and data protections that delay ANDA entry
- Scale-up and impurity control requirements to meet dissolution and stability specs
H2: How do you validate Pylera suppliers for due diligence, licensing, or litigation?
Featured-snippet answer: For high-stakes cases, the validated method is to map (1) drug product manufacturing and packaging sites from FDA labeling, (2) NDA CMC DMF references for each drug substance, and (3) facility inspection records to tie “paper suppliers” to “real GMP operators.”
Supplier due diligence checklist (evidence-grade)
- Drug product: Pylera label “manufactured for” and packaging/manufacturing address for current and prior lots.
- Drug substance: DMF holder names for each component (bismuth subcitrate potassium, metronidazole, tetracycline).
- GMP status: FDA inspection outcomes for each relevant facility.
- Batch traceability: lot number to packaging site and manufacturing site (where available through labeler distribution).
- Contracting proof: Quality agreements and supply agreements are often required in discovery for litigation.
H2: What patent or regulatory restrictions affect sourcing or generic supply of Pylera?
Featured-snippet answer: Supply substitution is constrained by patent estate and regulatory exclusivity on the fixed-dose combination. Even if a firm can supply APIs, it still needs the legal right to market the finished combination and the regulatory pathway to support an ANDA or other application.
How does Pylera composition impact biosimilar/generic pathways?
- Pylera is a small-molecule fixed-dose combination, not a biologic, so no biosimilar pathway.
- Generic entry is via ANDA for the combination or via permitted substitutes where allowed by product/formulation equivalence.
What does this mean for “supplier” strategy?
If the objective is to supply competitors or to source for a generic entrant, the key is not only finding an API supplier but also confirming:
- the right to combine those actives in the exact dosage form and labeling claim set
- the right to use the relevant formulation and manufacturing method
- the regulatory readiness to meet Pylera’s dissolution and stability requirements
Key Takeaways
- “Suppliers for Pylera” should be mapped as a three-layer system: drug substance (bismuth subcitrate potassium, metronidazole, tetracycline), dosage-form manufacturing, and packaging/distribution sites.
- Public data most reliably identifies the Pylera labeler (Allergan/AbbVie) and the drug product manufacturing/packaging sites shown on labeling and associated FDA records; full upstream API supplier lists typically require NDA/DMF traceability.
- For due diligence and litigation-grade sourcing, validate each component through DMF holder references and facility inspection records, then connect those entities to the specific dosage-form/packaging sites for Pylera lots.
FAQs
1) Who is the Pylera labeler/brand owner in the US?
Allergan (AbbVie) is the US brand labeler associated with Pylera in FDA and commercial documentation.
2) Are Pylera suppliers the same for every manufacturing lot?
No. Drug product manufacturing and packaging sites can change by lot or through supplements, even if the labeler remains constant.
3) Can a generic supplier use any metronidazole or tetracycline API vendor?
Only qualified vendors can be used in a CMC-compliant ANDA/finished product program; equivalence depends on impurity profiles, particle properties, and validated capsule performance.
4) Where can you find proof of who manufactured and packaged Pylera?
In Pylera’s FDA labeling “manufactured for” / “packaged by” address blocks and linked approval/CMC records that list manufacturing and packaging sites.
5) Does Orange Book listing fully reveal the API supplier network?
No. Orange Book typically supports product identity and authorized drug product details; API DMF holder-level supplier mapping generally requires NDA/DMF crosswalk evidence.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products. (Pylera entry).
- U.S. Food and Drug Administration. Drug Labeling and Prescribing Information for Pylera.
- U.S. Food and Drug Administration. Drug Master File (DMF) system and NDA CMC references (Pylera component DMFs as reflected in NDA submissions).
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