Chlorhexidine applications
A wide range of applications
Chlorhexidine is widely used as an active ingredient and excipient in both OTC and prescription drugs.
Applications include oral care, wound care, sore throat, bladder irrigation, anti-inflammatory, eye drops, antacid suspensions, antifungals.
A number of biocide products for skin disinfection are formulated with Chlorhexidine, including solutions with and without alcohol, scrubs, wet wipes, soaps, creams and hand rubs.
Chlorhexidine is commonly used in plaque control and gingivitis, healing before and after periodontal surgery, treatment of mouth ulcers, aphthous stomatitis and oral infections. Chlorhexidine is present in mouthwashes, toothpastes and sprays.
Cosmetics
Chlorhexidine is formulated as a preservative in cosmetic formulations such as skincare creams, hair conditioners and treatments, soap, deodorants, hygiene products, antiseptic treatments and insect repellent.
Veterinary
Chlorhexidine is normally used as an antiseptic and preservative in animal health products developed for the treatment of mastitis in cows and in pet products such as shampoo, foam and wipes.
Industrial
Chlorhexidine is also used for general disinfection of equipment, surfaces and textiles: surface wipes, floor cleaners, detergents and disinfectant spray.
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Chlorhexidine FDF Biocide
Chlorhexidine aqueous and alcoholic solutions, scrubs and wipes
Biocide solutions portfolio
Medichem offers a wide range of Chlorhexidine products in different presentations: aqueous (2% and 0.5%), alcoholic colored solutions (2% and 0.5%), alcoholic transparent solutions (2% and 0.5%) and wipes (2%) for the biocide market.
All of these are based on Chlorhexidine Digluconate as an active ingredient.
For more information, please contact us.
Aqueous
0.5%
2%
Alcoholic transparent
0.5%
2%
Alcoholic colored
0.5%
2%
Wipes
2%
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Efficacy studies according to European Standards
The following properties are the result of efficiency studies carried out in accordance with European standards.
Bactericidal efficacy
EN 1276
EN 13727:2012
• Hygienic Hand Rubbed
• Surgical Hand Rubbed
Surgical hand disinfection
EN 12791 (CDG 2%)
Anti-yeast efficacy
EN 1650
EN 13624:2013
• Hygienic Hand Rubbed
• Surgical Hand Rubbed
Hygienic and treatment by friction
EN 1500 (CDG 0.5%)
Presentations
A wide range of presentations is available.
Biocide solutions
- 500 ml
- 250 ml
- 125 ml
- 100 ml
- 75 ml
- 60 ml
- 10 ml ampoules
(single dose)
Biocide aqueous wipes
- Individual sachet
- Flow pack of 8 wipes
Biocide alcoholic wipes
- Individual sachet
Chlorhexidine FDF Pharma
Aqueous and alcoholic solutions for the pharmaceutical market
Pharma Portfolio
Medichem offers specific Chlorhexidine transparent aqueous and alcoholic solutions for the pharmaceutical market and will soon launch 2% alcoholic solutions, as well as colored versions of each solution. All these products are based on Chlorhexidine Digluconate as an active ingredient.
Medichem’s expertise in the European registration process and cGMP-approved facilities, combined with approval for our first dossier in The Netherlands, enables us to offer our customers dossiers ready to license out.
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Available
Solution
Alcoholic
Coming soon
Solution
Alcoholic
Colored
Solution
Alcoholic
Colored
Solution
Alcoholic
Medichem offers a wide range of Chlorhexidine products in different presentations: aqueous (2% and 0.5%), alcoholic colored solutions (2% and 0.5%), alcoholic transparent solutions (2% and 0.5%), hand scrub (4%) and wipes (2%) for the biocide market.
All of these are based on Chlorhexidine Digluconate as an active ingredient.
Ready
to License-out Dossiers
GMP
eCTD Dossier
Approved in The Netherlands
cGMP approved facility
Expertise in European Registration Process
Presentations
For pharmaceutical grade, the following formats are available:
30 ml
100 ml
250 ml
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Chlorhexidine API
Chlorhexidine API since 1985
Medichem started manufacturing chlorhexidine salts back in 1985. Since then, we have become one of the world’s largest manufacturers while enlarging our customer’s portfolio and expanding into new markets.
1985
+30 Years of experience
+250
Customers
+60
Countries
Double-digit
Growth
Stand-alone
Independent Business Unit
Top
Worldwide
Key Player
Unparalleled regulatory inspections record
Manufactoring site in Celrà (Spain)
Successfully
inspected since 1985
cGMP company
since 1985
ISO 14001
certified since 2001
Successfully
inspected
Extensive
API Chlorhexidine portfolio
Chlorhexidine salts have a very wide range of antimicrobial activity, being effective against gram-positive and gram-negative organisms. They also have fungicidal and sporicidal effects.
The main features of Chlorhexidine salts are the very low content of impurities particularly p-Chloroaniline and the consistent quality. This can only be achieved by a very careful and advanced process, carried out according to Good Manufacturing Practices and to a Quality Management System in our FDA inspected factory.
Since July 2001 Medichem has also been certified according to the ISO 14001 Environmental Management System.
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4 active
own-manufactured
ingredients
Base
Diacetate
Dihydrochloride
Digluconate 20%
Edge
Performance Products
Chlorhexidine is widely used as an active pharmaceutical ingredient, disinfectant, antiseptic, preservative or excipient.
An extremely versatile
and effective product
Broad spectrum efficacy
(bacteria’s, viruses and fungi)
Lower impurity profile
Safety-profile on the skin
Low irritation
Broad Regulatory expertise
All Medichem´s chlorhexidine Active Pharmaceutical Ingredients meet the highest European and North American regulatory standards.
Chlorhexidine
CEP
Those of our active pharmaceutical ingredients that have been granted a certificate of suitability are appropriate for use in medicinal products.
DMF
Medichem prepares and submits the Drug Master File to the appropriate regulatory authority in the intended drug market. The document provides the regulatory authority with confidential, detailed information about our facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Reach
All Medichem APIs comply with this regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals.
Regulatory status under the Biocidal Product Regulation
It is Medichem’s mission to excel and provide the highest quality. As such we have contributed to the development of the current EP and USP monographs for all Chlorhexidine salts.
These new monographs represent an enhanced and up-to-date standard, with limits for individual impurities according to ICH guidance.
Medichem Biocidal active ingredient for PT1, PT2 and PT3
Listed as Active Substance Supplierin accordance with art. 95