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By PharmaCompass
2022-02-25
Impressions: 2203
View Gentec's portfolio of various APIs including High potency APIs & Prostaglandins & browse its Contract manufacturing services on PharmaCompass.
Q1. What is Gentec and what services does it offer?
Established in 1985, Gentec is a contract manufacturing organization (CMO) which manufactures APIs (active pharmaceutical ingredients), HPAPIs (high-potency active pharmaceutical ingredients), advanced intermediates and fine chemicals for the pharmaceutical industry. It also provides raw materials to the food industry.
Gentec, with over 30 years of experience, has specialized multi-product plants to offer its clients a better logistics service, including documentation. Gentec’s facilities are EU GMP certified and it maintains the highest quality in compliance with the national and international pharmacopeia standards and customer requirements. It carries out all production, research & development and testing activities following the cGMP and ICH guidelines.
At present, Gentec manufactures and markets over 200 active pharmaceutical ingredients (APIs) and food ingredients for blue chip customers worldwide. Its industrial and technological know-how, innovative approach and adherence to the highest quality has allowed it to be at the forefront of new pharmaceutical developments. It also complies with the strictest technical and legal requirements. Gentec has a vast catalog of finished products under its contract manufacturing facilities.
Services
- API and HPAPI Contract manufacturing
Gentec, at its Duke Chem and Pharmanoid facilities, offers the development and manufacture of APIs, intermediates and HPAPIs (high-potency APIs), under the contract manufacturing modality. Its multipurpose and multi-product facilities are certified as cGMP compliant.
- Galenic Development
Teseo Farmacia is a research and development (R&D) technical advisory company for the pharmaceutical industry. Gentec offers collaboration with its clients in the following fields:
- Formulation studies
- Compatibility studies with excipients
- Establishment of the qualitative and quantitative formula
- Design of the manufacturing method
- Establishment of process controls
- Technology transfer to the client
- Analytical development
Study and validation of analytical methods to control the quality of the active pharmaceutical ingredients (APIs) as well as the impurities in the raw materials and the finished dosage forms.
- Documentation of the registration dossier and evaluation follow-up
Gentec, through its SIFarma business unit in Mexico City, offers solutions to each and every one in the pharmaceutical industry’s value chain. It is completely focused on the Mexican market, from the location of the APIs (active pharmaceutical ingredients) until the galenic development of the final products and confirmation of dossiers.
Q2. Where are Gentec’s facilities located and what do they manufacture?
Gentec is engaged in the development and manufacture of APIs, intermediates and HPAPIs. It has two industrial platforms in the Barcelona region in Spain that manufacture various active pharmaceutical ingredients (APIs) and prostaglandins for ophthalmic use. Gentec also offers API and HPAPI contract manufacturing services. A team of over 60 employees, including specialized professionals with extensive experience in the chemical and pharmaceutical sector, make up the organization.
DUKE CHEM
Its multipurpose and multi-product facilities, along with its quality system, are certified as cGMP compliant. Gentec, one of the leading contract manufacturing organizations (CMO) in the world, has a multifunctional plant dedicated to the development and manufacture of active pharmaceutical ingredients (APIs) as well as advanced intermediates and fine chemicals.
PHARMANOID
Gentec provides custom and contract manufacturing services, including process development from laboratory to industrial scale, at its Pharmanoid facility. Gentec’s Pharmanoid plant develops and manufactures high-potency active pharmaceutical ingredients (HPAPIs), including several prostaglandins for ophthalmic use. Its facilities are cGMP certified, which allows it to handle high-potency active pharmaceutical ingredients (HPAPIs) while providing a safe environment for the people.
GENTHEALTH
In 2016, a special division dedicated to the development, manufacturing and marketing of innovative ingredients was formed. This division, called GENTHEALTH, incorporates new assets from various therapeutic areas for the OTC market as well as the food supplements and functional food industry.
Q3. What are some of Gentec’s API offerings?
Gentec is a contract manufacturing organization (CMO) offering manufacturing of APIs, high-potency active pharmaceutical ingredients (HPAPIs), advanced intermediates and fine chemicals along with galenic development services for the pharmaceutical industry.
Gentec offers its partners the possibility to conduct pharmaceutical development activities from the initial selection of alternatives to the final registration, including licensing and supply of final pharmaceutical products. Gentec currently manufactures and markets over 200 active pharmaceutical ingredients, including some first generation APIs.
Gentec’s multifunctional plants are designed to execute complex multi-step industrial processes. The various APIs that are manufactured in its plant include Bepotastin, Brinzolamide, Dorzolamide, Etofenamate, Lifitegrast, Nitazoxanide, Silodosin, Febuxostat, Azithromycin, etc. Gentec also manufactures prostaglandins for ophthalmic use and progestogens including Bimatoprost, Latanoprost, Latanoprostene Bunod, Carboprost, Tafluprost and Travoprost.
Gentec not only offers development and manufacture of APIs and intermediates but also provides products for the nutrition and food industry. Gentec’s Nutraceutical division incorporates new active ingredients in different therapeutic areas for the OTC market, the food supplements and functional food industry. The Nutraceutical division develops, manufactures and markets innovative ingredients, such as Neurasites, Dropsordry, Iridafran and H2Oslim, among others.
APIs in Distribution
Gentec not only offers API and HPAPI Contract manufacturing services but is also involved in the distribution of APIs. Gentec has its own offices in strategic countries to provide comprehensive solutions to meet the demands of its customers.
Q4. What are the products offered by Gentec to the food industry?
Since its formation in 1985, Gentec S.A. has established itself as a leader in providing raw materials and ingredients to the food, diet and nutrition industry. Gentec’s nutraceutical division supplies food supplements to the functional food industry.
Gentec provides a wide range of services, including legal aspects, such as licenses to develop product ranges and market advice. Gentec works on new applications and formulations, provides solutions and collaborates with its customers for better and sustained growth.
Gentec’s employees carry out market research continuously and are always on the lookout for opportunities to introduce new product lines, thereby contributing to the development of new businesses. Gentec relies on its R&D employees for research, development, improvements and applications to provide better services to the companies and/or clients it represents.
Gentec has a wide range of products for the food industry, such as:
- Powdered Fats
- Soy Flour
- Lecithins
- Egg and powdered derivatives
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