Suppliers and packagers for generic pharmaceutical drug: OMADACYCLINE TOSYLATE

OMADACYCLINE TOSYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817	NDA	Paratek Pharmaceuticals, Inc.	71715-001-02	10 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01)	2019-02-01
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816	NDA	Paratek Pharmaceuticals, Inc.	71715-002-21	1 BLISTER PACK in 1 CARTON (71715-002-21) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)	2019-02-01
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816	NDA	Paratek Pharmaceuticals, Inc.	71715-002-27	5 BLISTER PACK in 1 CARTON (71715-002-27) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)	2019-02-01

OMADACYCLINE TOSYLATE Suppliers: Key API Makers, Finished-Dose Contract Manufacturers, and Supply-Chain Barriers

Last updated: May 24, 2026

Suppliers for omadacycline tosylate fall into two buckets: (1) API and key intermediate manufacturers that make omadacycline (free base) and convert to the tosylate salt, and (2) contract manufacturers that formulate and fill the marketed oral tablets. Supply-chain risk is driven by the number of qualified API producers, salt-form capability (tosylate formation and crystallization control), and scale of tablet manufacturing under GMP.

Which companies supply omadacycline tosylate API and intermediates?

Omadacycline is sold globally under the brand Nuzyra (Bristol Myers Squibb). The reference product’s supply chain is built around CMOs for formulation and packaging, with API sourced from qualified manufacturers and route-specific intermediate suppliers. Omadacycline is not an established commodity API; qualified suppliers are narrower than for older tetracyclines.

How to identify true “API suppliers” for omadacycline tosylate

The market effectively has three “supplier” layers that procurement teams should map:

1. API manufacturers that make omadacycline active pharmaceutical ingredient (free base).
2. Salt-form manufacturers that form and control omadacycline tosylate (crystal form, particle size, water content).
3. Intermediate suppliers for key cyclization, functional-group installations, and chiral or late-stage intermediates used in the API synthesis.

Because salt-form capability can be separated from free-base API manufacture, a “manufacturer of record” may not be the entity that converts the free base to the tosylate.

Supplier mapping used in licensing and qualification

In practice, qualification dossiers and vendor audits often distinguish:

• API site (GMP certificate, CEP if applicable)
• Salt formation step (control strategy, crystallization and filtration capability)
• Analytical package (form, polymorph, residual solvents, sulfate/tosylate analysis)

This determines whether procurement can dual-source without reformulation risk.

What suppliers make the tosylate salt form of omadacycline?

Omadacycline tosylate requires a robust salt-form process: controlled addition of tosylate reagent, crystallization conditions, wash solvent choice, and drying to meet residual solvent and moisture limits. This is frequently a differentiator between API suppliers even when the upstream free-base route is similar.

What should be checked in salt suppliers

• Salt identity and form controls (tosylate confirmation plus polymorph or hydrate state)
• Particle size distribution to protect downstream tablet compressibility and dissolution
• Residual solvent and impurity profile set by the reference product’s quality target product profile

What makes salt-form capacity a bottleneck

• Scale-up crystallization control (batch-to-batch variability)
• Ability to maintain specification during milling or drying
• Compatibility with late-stage impurity profiles that can shift during salt conversion

Which contract manufacturers produce omadacycline tablets for Nuzyra?

Nuzyra is an oral tablet product. Tablet CMOs typically handle:

• blending (powder distribution control),
• granulation if applicable,
• compression,
• coating,
• packaging (blister or bottle configurations),
• stability program management.

How tablet CMOs get qualified

Qualification is driven by alignment with:

• tablet formulation and process parameters,
• impurity carryover risk from API lots,
• dissolution and bioavailability bridging requirements if API source changes.

Supply-chain drivers for tablet manufacturing

• compressed tablet manufacturing line capacity and changeover time,
• analytical support (dissolution method robustness and stability-indicating assays),
• packaging line availability to meet safety stock targets.

What patent and regulatory constraints affect supplier switching for omadacycline tosylate?

Supplier switching is constrained by regulatory listing and patent/market exclusivity conditions. For R&D and litigation planning, the key point is that supply of a generic or follow-on product depends on regulatory clearance and freedom-to-operate, not only on manufacturing capability.

What to check for supplier risk in the US

• Whether the product is listed in FDA’s Orange Book with relevant patents covering drug substance, drug product, and use.
• Whether any pending paragraph IV challenges exist that could reshape supplier authorization timelines.

How exclusivity and Orange Book listings affect procurement

Even if a supplier can produce API, commercialization timing can be blocked by:

• data exclusivity and patent barriers,
• requirements for ANDA/505(b)(2) approvals tied to listed patents,
• need for comparability in dissolution and impurity control.

Which generic or follow-on pathways create new omadacycline tosylate supplier opportunities?

New supplier entrants typically appear after one of the following:

• a generic ANDA approval creates an authorized downstream API demand signal,
• a 505(b)(2) product or reformulation expands the approved formulation space,
• patent expirations and settlements clear the market for additional manufacturers.

What changes when a new ANDA enters

• API sourcing diversifies because new manufacturers buy from additional qualified API makers.
• Tablet manufacturing shifts among CMOs based on line availability and packaging requirements.
• Salt-form control becomes standardized if the ANDA uses the same salt form and meets dissolution requirements.

How to evaluate whether a supplier is “qualified” for omadacycline tosylate commercial supply

Procurement teams should require evidence across GMP, quality, and transfer readiness:

Qualification checklist (operational)

• GMP compliance for API and salt-form operations
• documented salt-form capability (tosylate formation and controlled crystallization)
• full analytical method readiness (impurities, residual solvents, form identity)
• stability data support for API and salt form
• ability to support tech transfer with process robustness

Qualification checklist (business and timeline)

• batch size capability aligned to projected demand
• lead times for API release and tablet feed readiness
• contingency capacity for cyclone changes in supply (limited salt-form sites are a common risk)

What are the main barriers to dual-sourcing omadacycline tosylate?

Dual-sourcing is constrained by three recurring issues:

1. Limited salt-form capability for consistent tosylate crystal and particle characteristics.
2. Impurity profile sensitivity: different upstream routes and intermediate suppliers can change impurity patterns, driving revalidation and rejection risks.
3. Regulatory transfer friction: tablet bio-relevance depends on dissolution and impurity control, so bridging can be required even when the API is chemically equivalent.

Key Takeaways

• Omadacycline tosylate supply is concentrated around a narrow set of qualified API and tosylate-salt capable manufacturers plus tablet CMOs with verified dissolution and packaging performance.
• Salt-form capability (tosylate crystallization and particle control) is often the main bottleneck in supplier switching.
• Supplier switching is constrained by regulatory listing and patent landscape; commercial readiness depends on approvals and freedom-to-operate, not only on manufacturing capability.

FAQs

1) Can the same manufacturer supply both omadacycline free base and omadacycline tosylate salt?

Yes, but salt conversion is sometimes performed at a different site or through a dedicated salt-form process within a manufacturer’s network. Qualification should be based on actual tosylate formation capability and specs, not only on API synthesis.

2) What quality tests matter most for omadacycline tosylate suppliers?

Salt identity, form/polymorph or hydrate state, residual solvents, moisture, impurity profile, and dissolution-relevant particle attributes are the most operationally critical tests for downstream tablet performance.

3) Is API alone enough to qualify a new tablet manufacturer for omadacycline?

No. Even with the same API chemical identity, tablet performance depends on process compatibility and dissolution. A change in API source can trigger additional bridging and comparability work.

4) What supply risks are typical for salt-form APIs like omadacycline tosylate?

Crystallization scale-up variability, drying and filtration control, and specification drift on moisture/particle size are common causes of batch rejection and longer qualification timelines.

5) When do new suppliers usually enter omadacycline tosylate manufacturing?

New entrants tend to appear after regulatory approvals expand demand for follow-on products and after patent and exclusivity periods clear or settle, creating a stable commercial offtake to justify tech transfer and qualification spend.

References

1. FDA, Orange Book database (accessed via FDA Drugs@FDA / Orange Book listings).
2. FDA Drugs@FDA database (Nuzyra product page, application details).