Suppliers and packagers for generic pharmaceutical drug: PAROMOMYCIN SULFATE

PAROMOMYCIN SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Heritage	PAROMOMYCIN SULFATE	paromomycin sulfate	CAPSULE;ORAL	065173	ANDA	Waylis Therapeutics LLC	80725-250-01	100 CAPSULE in 1 BOTTLE (80725-250-01)	2021-04-08

Suppliers for Pharmaceutical Drug: Paromomycin Sulfate

Last updated: April 26, 2026

Which companies supply paromomycin sulfate API or drug substance?

Paromomycin sulfate is supplied globally for use in human and veterinary medicines. Supplier visibility varies by grade (API versus intermediates, sterile process materials, or food/veterinary grades) and by whether the company markets as primary API manufacturer or as distributor/authorized reseller.

Non-exhaustive supplier set identified from product listings and commercial supply channels:

Supplier	What they supply	Market positioning visible in listings	Geographic footprint (as shown)
Tianjin Dahe Pharmaceutical Co., Ltd.	Paromomycin sulfate (API)	Product catalog supplier	China (company listing)
TCI Chemicals	Paromomycin sulfate	Specialty chemical supplier (can support research/industrial demand)	Japan-headquartered, global distribution
MedChemExpress (MCE)	Paromomycin sulfate	Research chemical supplier	China-headquartered, global distribution
Cayman Chemical	Paromomycin sulfate	Research-grade supplier	US-based, global distribution

Note: Several of the above are known for research chemical catalog supply; they may not all be suitable as commercial GMP API sources without qualification for your intended regulatory path.

Which supplier channels exist for paromomycin sulfate?

Supplies typically come from four channel types, each with different due-diligence requirements.

1. GMP API manufacturers (primary)

   • Provide paromomycin sulfate as drug substance under GMP (typically with CoA, impurity profile, and regulatory documentation).
   • Best fit when you need routine commercial API supply or dossier alignment.

2. Authorized distributors / regional resellers

   • Sell branded inventories sourced from API manufacturers.
   • Best fit when you need fast availability and can manage manufacturer transparency via the distributor.

3. Specialty chemical suppliers

   • Provide paromomycin sulfate for laboratory or industrial use with varied quality systems.
   • Best fit for development stage, process screening, or non-clinical use pending qualification.

4. Veterinary and fermentation-sector distributors

   • Paromomycin is also used in veterinary contexts; some suppliers emphasize feed/vet grades.
   • Best fit when the regulatory target is veterinary or food-animal use, subject to local requirements.

What due diligence should be applied to any paromomycin sulfate supplier?

For a drug substance procurement decision, screen suppliers using the same core evidence set, then narrow based on intended use (clinical trial, commercial, or non-clinical).

Documentation and quality

• GMP status and site qualification
• Batch CoA with spec ranges (assay, impurities, moisture, residue on ignition if applicable)
• Impurity profile: identification of known related substances and limits strategy
• Stability package (if available for commercial lot planning)
• Change control and deviation history for recent production blocks

Analytical package

• Method availability for key tests (HPLC methods for related substances are typical)
• Reference standard sourcing and traceability
• Demonstrated compliance against pharmacopeial targets (where relevant)

Supply assurance

• Minimum order quantities and lead times
• Capacity statements tied to actual release volumes
• Packaging format consistency with your downstream process (drum, bottle, liner requirements)

Supplier shortlists by likely fit

Use this as a practical starting screen based on how companies present paromomycin sulfate in public listings.

Shortlist target	Likely best-fit supplier channel	Why it fits
Development or lab supply	Research-grade catalog suppliers	Faster quoting and smaller packaging options are common
Clinical trial material	GMP-capable manufacturers or authorized distributors	Need consistent impurity control and documentation
Commercial API	Primary manufacturers	Direct control of supply chain and impurity evolution

What grade and specification matters for paromomycin sulfate?

Public product listings often do not show full GMP API specs in one place. In practice, paromomycin sulfate sourcing decisions hinge on:

• Purity/assay target
• Related substances (each supplier’s impurity naming and limits differ)
• Solvate/water content (if any variation exists in the commercial feed)
• Pharmacopeial alignment (USP/EP monograph compliance where required)

Commercial procurement approach

A procurement process usually resolves in two steps:

1. Qualify one “primary” supplier
   • Secure long-term supply with documented quality package and consistent impurity profile.
2. Add a second qualified source
   • Build supply resilience against shortages or manufacturing interruptions.

Key Takeaways

• Paromomycin sulfate has multiple publicly visible suppliers spanning API catalog sellers and specialty chemical distributors.
• Use a two-lane strategy: identify a primary source for GMP-compatible supply and maintain at least one alternate supplier for continuity.
• The decisive factor is not listing availability but GMP status, CoA evidence, impurity control, and change control.

FAQs

1. Is paromomycin sulfate supplied as an API and as research-grade chemical?
   Yes. It appears in both commercial API supply channels and research chemical catalogs.

2. Do distributors supply the API under GMP?
   Some do via authorized supply from GMP manufacturers. The distributor’s listing alone is not proof; qualification requires documentation linking product to the GMP site.

3. Which tests determine quality for paromomycin sulfate procurement?
   Assay and related substances (impurity profile), plus moisture/residual indicators as specified in the target monograph or agreed spec.

4. How do suppliers typically differentiate paromomycin sulfate products?
   By grade (research vs commercial), packaging, purity/assay, and impurity limits.

5. What is the main risk in supplier selection for paromomycin sulfate?
   Mismatch between catalog-grade material and the required GMP, specification, or stability package for the intended regulatory use.

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References (APA)

[1] TCI Chemicals. (n.d.). Paromomycin sulfate product listing. https://www.tcichemicals.com/
[2] Tianjin Dahe Pharmaceutical Co., Ltd. (n.d.). Paromomycin sulfate product page. https://www.tianjindahe.com/
[3] MedChemExpress (MCE). (n.d.). Paromomycin sulfate product listing. https://www.medchemexpress.com/
[4] Cayman Chemical. (n.d.). Paromomycin sulfate product listing. https://www.caymanchem.com/