Laxatives & Colonic Lavage

Polyethylene Glycol Active Pharmaceutical Ingredients

We offer Polyethylene Glycol as an Active Pharmaceutical Ingredient (API) with exceptional quality and consistency, based on 40+ years of pharmaceutical manufacturing expertise. Our ICH Q7-compliant facilities utilize dedicated reactors, cGMP production, handling, and storage to ensure regulatory compliance (see table below for global registrations). 

Our CARBOWAX™ SENTRY™ Polyethylene Glycols (PEGs) 3350 and 4000 (Uninhibited), also known as Macrogol 3350 & 4000, are active pharmaceutical ingredients (APIs) that are highly water soluble and used in multiple dosage forms. 

Ideal for osmotic laxative formulations for mild and effective treatment to relieve constipation for digestive health. Constipation is a known symptom of GLP-1 users.
Widely used in intestinal lavage formulations to facilitate bowel cleansing prior to medical procedures such as colonoscopies, radiological exams, or gastrointestinal surgery.

Solutions for laxative applications 

Products
Packaging Types
Formulation

A preferred API for laxative formulations

Best in class product features and manufacturing

World scale production facilities with dedicated reactors

Mild and effective treatment to relieve constipation

Consistency in taste and dissolution time

Dependable fill properties due to flow characteristics

Consistent bulk density, ensuring proper volume of product in your bottle or sachet

Complies with ICH Q7 guidelines for APIs

Global Registrations – CARBOWAX™ SENTRY™ PEG API

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Country/Region	CARBOWAX™ SENTRY™ PEG 3350 (Uninhibited), Granular	CARBOWAX™ SENTRY™ PEG 3350 (Uninhibited), Powder	CARBOWAX™ SENTRY™ PEG 4000 (Uninhibited), Powder
United States	US DMF	US DMF	US DMF
Canada	CEP¹	CEP¹	CEP¹
European Union	CEP²	CEP²	CEP²
China	DMF	DMF	DMF
Japan		DMF
Korea		DMF
Thailand			DMF
Technical Dossier: Chemistry, Manufacturing and Control (CMC)	CMC	CMC	CMC

¹ Guidance Document: Use of Certificates of Suitability (CEP) as supporting information in Drug Submissions (11.1)

² Based on information received from regulatory authorities and trade associations, the following countries accept CEPs, some with conditions: Albania, Algeria, Australia, Azerbaijan, Canada, Georgia, Ghana Israel, Kyrgyzstan, Malaysia, Moldova, Morocco, New Zealand, Saudi Arabia, Singapore, South Africa, Tunisia, and Uzbekistan. CEPs are also accepted (with conditions) by the Taiwan Food and Drug Administration. Please note that this is not an exhaustive list

Product Details

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Brand / Trade name	CARBOWAX™ SENTRY™
Packaging size	25 kg bag, 50 lb bag, 2000 lb supersack
UNI Numbers	3WJQ0SDW1A, G2M7P15E5P
Physical Form	Granular & Powder
Chemical Name	Polyethylene glycol
Manufacturing Site	St. Charles Operations, Hahnville, Louisiana, US