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 Paromomycin Sulfate

Last updated: February 20, 2026

Paromomycin sulfate is an aminoglycoside antibiotic used to treat intestinal infections caused by protozoa and helminths. It is available from various pharmaceutical suppliers globally, primarily in generic form for both human and veterinary applications.

Major Suppliers and Manufacturers

Supplier/Manufacturer	Location	Product Details	Certification / Regulatory Status	Market Focus
Cipla Limited	India	Paromomycin sulfate IP bulk powder	DMF registered, GMP compliant	global, especially Asia, Africa
Sun Pharmaceutical Industries	India	Paromomycin sulfate capsules and bulk	WHO-GMP, USDMF	worldwide, OTC availability varies
Medipharm Laboratories	USA	Paromomycin sulfate for injectable and oral use	FDA approved (Investigational or marketed)	US, global supply chain
Sigma-Aldrich (Merck)	Germany/USA	Paromomycin sulfate USP grade	Certified for research use only	research, clinical trials
Sandoz (Novartis)	Switzerland	Paromomycin formulations	Regulatory approvals, varies by country	international markets

Key Suppliers by Region

Asia

• Cipla, Sun Pharma, Alkem Labs, Glenmark produce bulk and finished formulations sold mainly within India and exported globally.
• Manufacturers often supply bulk active pharmaceutical ingredient (API) under cGMP standards.

North America

• Sandoz and Medipharm offer certified APIs and finished dosage forms for clinical and commercial use.
• US suppliers focus more on compliance with FDA regulations and Good Manufacturing Practice (GMP).

Europe

• Sigma-Aldrich (part of Merck) supplies research-grade paromomycin sulfate.
• Sandoz and other European contract manufacturers produce for pharmaceutical companies seeking to develop or market new formulations.

Regulatory and Certification Standards

• API suppliers typically hold certifications like FDA Drug Master Files (DMFs), European Medicines Agency (EMA) approvals, or World Health Organization (WHO) prequalification.
• Finished dosage form suppliers require Good Manufacturing Practice (GMP) compliance for marketed products.

Quantities and Pricing

• Suppliers provide APIs in bulk quantities starting from 1 kg, with prices varying by purity, certification, and order size.
• Typical API cost ranges from $50 to $150 per gram, highly dependent on supplier, grade, and market conditions (as of 2023).

Market Dynamics

• The demand pushes supply primarily from Indian and Chinese manufacturers.
• Increased use in anti-amoebic and anti-parasitic therapies maintains steady market activity.
• Patent expiries and the move towards generic formulations expand supplier options.

Supply Chain Risks

• Quality variability among suppliers remains a concern.
• Some suppliers have faced regulatory scrutiny, affecting supply stability.
• Regional disruptions (e.g., export bans, COVID-related delays) impact availability.

Summary

Paromomycin sulfate is supplied mainly by Indian pharmaceutical companies, with additional suppliers in North America and Europe. Suppliers hold various certifications aligning with target markets' regulatory standards. The active ingredient is available in bulk for manufacturing generic and branded formulations, with prices typically ranging from $50 to $150 per gram. The supply landscape is driven by high regional demand, primarily for anti-infective therapies.

Key Takeaways

• Indian companies such as Cipla and Sun Pharma dominate bulk API supply.
• US and European suppliers offer research-grade and GMP-certified production.
• Pricing fluctuates based on purity, batch size, and regulatory compliance.
• Regulatory certifications influence market access, especially in regulated markets like the US and EU.
• Supply stability relies on quality control and geopolitical factors.

FAQs

1. What are the main regulatory standards for paromomycin sulfate suppliers?
   Suppliers typically adhere to GMP for marketed products, and may hold DMFs or similar filings with regulatory bodies such as the FDA or EMA.

2. Can I source paromomycin sulfate for clinical research?
   Yes, research-grade API from companies like Sigma-Aldrich is available, but it is not suitable for human administration.

3. Is paromomycin sulfate available as a finished dosage form globally?
   Availability varies; in some regions, it is marketed as capsules or injectables, while in others it is only accessible as bulk API.

4. How does regional regulation impact supplier choice?
   Suppliers in developed markets typically meet stricter standards, influencing procurement for regulated pharmaceuticals versus research or veterinary uses.

5. What are the key aspects to consider when selecting a supplier?
   Certification (GMP, DMF), pricing, product purity, lead time, and supply reliability are critical factors.

Sources

1. World Health Organization. (2022). Expert Committee on Specifications for Pharmaceutical Preparations. WHO Technical Report Series, No. 1023.
2. US Food and Drug Administration. (2021). Drug Master Files and Abbreviated New Drug Applications.
3. Indian Pharmacopoeia. (2022). Government of India.
4. Sigma-Aldrich. (2023). Catalog data on paromomycin sulfate.
5. European Medicines Agency. (2023). Summary of product characteristics for marketed paromomycin formulations.