Suppliers and packagers for generic pharmaceutical drug: lefamulin acetate

lefamulin acetate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673	NDA	Meitheal Pharmaceuticals Inc.	71288-039-16	6 VIAL, SINGLE-USE in 1 CARTON (71288-039-16) / 15 mL in 1 VIAL, SINGLE-USE (71288-039-15)	2019-09-09
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673	NDA	Meitheal Pharmaceuticals Inc.	71288-040-65	6 BAG in 1 CARTON (71288-040-65) / 270 mL in 1 BAG (71288-040-64)	2019-09-09
Hong Kong	XENLETA	lefamulin acetate	TABLET;ORAL	211672	NDA	Meitheal Pharmaceuticals Inc.	71288-037-10	10 TABLET, COATED in 1 BLISTER PACK (71288-037-10)	2019-09-09

Suppliers and packagers for generic pharmaceutical drug: lefamulin acetate

Last updated: July 24, 2026

Lefamulin Acetate Suppliers: Who Manufactures Active Ingredient and Finished Dosage Forms for Pharmaceutical Supply Chains

Executive summary: Lefamulin acetate supply is dominated by a small set of chemistry and fill-finish vendors tied to the approved brand pathway (Xenleta, lefamulin oral tablets/IV product). Commercial availability depends on who holds (1) active pharmaceutical ingredient (API) manufacturing, (2) finished-dose manufacturing, and (3) packaging and release testing roles for each licensed product site. Public documentation is fragmented across FDA chemistry/manufacturing review packages, Orange Book references, drug master files, and inspection histories, so supplier identification must be anchored to FDA-registered manufacturing sites and label-specific manufacturing/release statements.

What companies supply lefamulin acetate API and finished drug product?

A reliable supplier map for lefamulin acetate starts with the FDA package insert “Manufactured for” and the drug product listing that ties the dosage form to specific manufacturing and testing sites (listed in the FDA’s product label and drug establishment records). For Xenleta (lefamulin), supplier identities generally fall into three buckets:

• API manufacturer(s) for lefamulin (later salt formation to lefamulin acetate).
• Drug product manufacturer(s) that compress tablets or fill/finish the IV presentation.
• Batch release and quality control sites, often separate from the synthesis site.

Key point for procurement: if you source lefamulin acetate, your counterparty is typically contracted through the brand’s manufacturing network. Direct “API spot” supply is uncommon when the branded product controls demand and licensed sites.

Where to find definitive supplier names in FDA documents

For business decisions (sourcing, dual sourcing, regulatory change risk), the authoritative supplier data points are:

• FDA label manufacturing section: lists the company and address credited in the label for manufacturing and/or packaging.
• Drug listing in FDA’s Drugs@FDA: includes the marketed product and application type.
• Orange Book: maps branded product to NDA and patent/EX exclusivity, but not always granular site-by-site supplier identity.
• CDER inspection/establishment data: ties manufacturing sites to corporate identities.

Common supplier roles you should map

Even when public names are incomplete, contracts usually separate:

• Salt-form conversion (formation of lefamulin acetate from lefamulin free base or alternative salt forms).
• Solid oral dosage form processing (tablet manufacturing, blend, compression, film coating if applicable).
• Sterile IV manufacturing (aseptic processing, container closure system, sterile filtration, and fill/finish).
• Analytical release testing (potency, assay, related substances, residual solvents, sterility/endotoxin where applicable).

What patents protect lefamulin acetate suppliers and manufacturing sites?

Supplier constraints often connect to patent estate coverage, not only manufacturing capability. When patent claims protect intermediates, polymorphs, crystallization conditions, or formulations, generic and parallel-supply entrants face an IP barrier to making the same drug substance or finished form.

How manufacturing and formulation patents can limit alternative sourcing

For a salt like lefamulin acetate, patent scope may cover:

• Salt formation parameters (reagents, solvent system, temperature profile, crystallization/precipitation conditions).
• Drug substance intermediates (key chemical steps that require licensing or design-around).
• Solid-state forms (hydrates/solvates, particle size distributions, polymorphs).
• Finished-dose formulation (excipients, coating, film composition, process parameters).

Practical impact: alternative suppliers can often make “chemically similar” lefamulin salts, but may still face infringement risk if claims cover specific process conditions or solid-state characteristics.

What this means for supplier due diligence

Procurement due diligence on lefamulin acetate typically must include:

• Patent coverage review for the salt and drug substance.
• Confirmation of whether the supplier’s process is independently developed or license-backed.
• Documentation on batch reproducibility and solid-state characterization.

What is the Orange Book status of Xenleta (lefamulin) that affects supply?

Orange Book status determines whether alternative manufacturers can legally market generic or 505(b)(2) products that would compete with Xenleta. While Orange Book does not directly list “API suppliers,” it drives the number of legally viable supply-network participants.

Featured snippet answer: Xenleta’s Orange Book listing controls brand exclusivity and patent barriers for generic competition, which indirectly influences supplier availability by limiting new entrants to the licensed manufacturing ecosystem.

How Orange Book status affects supply strategies

• During strong exclusivity/patent periods: brand supply networks remain the only commercially reliable sources.
• After patent cliffs: additional suppliers can emerge through authorized generics, licensed manufacturing, or generic launches that add scale.

When does lefamulin acetate lose exclusivity, enabling new suppliers and generics?

Exclusivity and patent expiry drive the timing for more supplier entrants:

• NDA exclusivity (new chemical entity and related statutory exclusivities).
• Market exclusivity extensions tied to pediatric, certain regulatory milestones, or supplemental applications.
• Patent expiration schedule for composition of matter, salts, intermediates, and formulations.

Procurement relevance: supplier diversification and contract renegotiations tend to cluster around patent-expiration and generic entry windows.

Which regulatory filings and FDA pathways influence manufacturing access to lefamulin acetate?

NDA vs. ANDA vs. 505(b)(2) implications

• ANDA route generally requires bioequivalence and generic composition, which can create upstream manufacturing scale pressure.
• 505(b)(2) route can rely on literature/bridging and still require manufacturing that matches the approved drug substance and formulation sufficiently to avoid failed bridging.
• Authorized generics can allow additional manufacturing capacity while preserving brand exclusivity restrictions.

Supplier implication: new contract manufacturers are more likely to enter when there is a defined downstream regulatory route that justifies their compliance and validation costs.

Which finished dosage forms require separate supplier networks for lefamulin acetate?

Lefamulin acetate is supplied in at least two clinically used presentations for the Xenleta product line:

• Oral tablets (solid oral manufacturing).
• IV formulation (sterile manufacturing and aseptic controls).

These represent different supplier qualification tracks:

• Oral: non-sterile GMP, tablet process validation, coating and moisture control.
• IV: sterile GMP, container closure validation, endotoxin/sterility release, aseptic processing controls.

What generic entry risks exist for lefamulin acetate supply?

Potential entry risks that affect supply reliability include:

• Process-specific salt-form IP (if lefamulin acetate is claimed with defined process features).
• Solid-state control (particle size distribution, polymorph stability, solvent residues).
• Sterile IV complexity (higher batch rejection rates and slower scale ramp).
• Supply chain fragility (limited number of validated sites that can handle API-to-finished conversion).

Operational consequence: even when regulatory entry becomes possible, real-world supplier additions can lag due to quality systems, validation duration, and release testing capacity.

How strong is the patent estate for lefamulin acetate and related drug substance?

A strong patent estate can keep supply constrained by:

• preventing legally compliant generics from using protected composition or process,
• limiting contract manufacturing for alternative product pathways.

Business lens: supplier availability is less a pure chemistry issue and more a legal manufacturing-access issue.

How does lefamulin acetate supplier capacity compare with other antibacterial drugs?

Compared with high-volume small molecules, lefamulin acetate occupies a smaller commercial base, which often results in:

• fewer qualified manufacturing and testing sites,
• higher dependence on the brand’s licensed network,
• lower willingness of major CDMOs to invest in dedicated line qualification unless downstream demand is guaranteed.

What manufacturing/IP barriers stop third-party supply of lefamulin acetate?

The most common barriers are:

• Drug substance process patents that define critical steps or intermediates.
• Salt formation and crystallization conditions that are claimed.
• Finished-dose formulation and process patents for tablets or IV.
• Regulatory data exclusivity and patent linkages in Orange Book that influence ANDA/505(b)(2) strategy.

Key Takeaways

• Lefamulin acetate supply is concentrated within a limited manufacturing ecosystem tied to the Xenleta product approvals.
• Supplier identification is operationally driven by FDA label manufacturing statements and registered establishment sites, not by generic “API supplier” headlines.
• Patent and exclusivity status shape supplier diversification timing and determine whether third-party manufacturing can legally support competing products.
• Oral and IV presentations rely on different supplier networks, so procurement must map dosage-form-specific sites.
• IP barriers most often target salt-form/process and solid-state control, which can limit alternative sourcing even when chemical synthesis capability exists.

FAQs

1. How do I verify a claim that a company supplies lefamulin acetate API for commercial use?
   Match the supplier’s role to FDA-registered manufacturing sites and the approved product’s label manufacturing/release statements.

2. Do suppliers differ between lefamulin acetate tablets and IV presentations?
   Yes. Oral and IV manufacturing and release testing require different sterile/non-sterile GMP systems and validation scopes.

3. Can a supplier sell “lefamulin acetate” without infringing lefamulin-related process or salt patents?
   Only if their salt-formation and solid-state outcomes avoid claim coverage for protected processes, intermediates, and forms.

4. What regulatory filing types typically expand supply for branded antibiotics like lefamulin?
   ANDAs and 505(b)(2) approvals, plus authorized generics, can expand supply when exclusivity and patents permit.

5. What is the highest-risk point in the lefamulin acetate supply chain?
   Batch release for the specific dosage form, especially for IV sterile manufacturing, due to quality failure sensitivity and constrained validated capacity.

References

1. U.S. Food and Drug Administration. Drugs@FDA: Xenleta (lefamulin) prescribing information and product details.
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for Xenleta (lefamulin).
3. U.S. Food and Drug Administration. FDA label manufacturing and packaging information for Xenleta (lefamulin) (accessed via Drugs@FDA).