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Manufacturing Facilities.
Creative Drug Industry has established a state of art facility conforming to the exacting standards demanded by revised norms of FDA.
It has well designed manufacturing facilities comprising of raw material reception – processing- extracting-dispensing to deal with varied allergen raw materials like mites, pollens, fungi, dusts, insect, foods etc. Manufacturing areas are designed to facilitate unidirectional, easy and natural movements for men and material.
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CREATIVE DRUG INDUSTRIES appreciates that the allergologist needs high quality, reliability and predictability from the allergens meant for patients who depend on him. There can be no compromise in the patient’s care, and we understand the crucial role of
our products and services in the system.
Highlights of the allergen technology adopted by CDI in the manufacture of diagnostic and therapeutic allergens are:
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Skin Test Allergens :
Credisol Skin Test Antigens are aqueous allergen extracts containing 50% glycerine and preserved with 0.4% phenol with their strength expressed in Protein Nitrogen units (PNU)
The modified prick test method is recommended for performing skin testing. This method reduces testing allergen use giving approximately 150 tests per vial.
Prick Testing is the most convenient and sensitive of the skin testing techniques, it is:
- A faster testing process and is convenient and painless
- Specificity and reproducibility are good.
- Correlates well with in-vitro methods e.g.RAST, specific IgE.
- Minimises risk factors while testing.
CREDISOL Skin Test allergens are active allergenic substances such as pollen, fungal spores, dust mites, dusts, insects, animal epithelia and foods in PNU strengths as given in the Table. Colour coding provides easy identification and prevents mix-ups in application.
Skin Test Allergens are :
Sr.No |
Allergen |
PNU/ml |
Colour Code |
1 |
Pollen |
5000 |
Green |
2 |
Fungi |
5000 |
Yellow |
3 |
Mite (Dermatophagoides ferinae) |
1500 |
Orange |
4 |
Mite (Dermatophagoides pteronyssinus |
1000 |
Orange |
5 |
Dust |
5000 |
Orange |
6 |
Epidermal /Epithelia |
5000 |
Blue |
7 |
Insect |
1000 |
Red |
8 |
Food (Lyophilised) |
1% W/V |
Brown |
9 |
Control |
------- |
White |
Presentation :
Each Allergen is provided in a 1.0 ml application vial. The use of mixed allergen for skin testing is not recommended since, in the case of positive reaction, it does not indicate which component of the mixture is responsible for the reaction, while in the case of negative reaction, it fails to indicate whether the individual allergens at full concentration would give a positive reaction.
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Quality Assurance
Allergenic raw materials are obtained from the relevant sources with high degree of purity. Not more than 1% foreign pollens as determined by microscopic examination is allowed. |
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Skin Test Allergens
Credisol Skin Test Antigens are aqueous allergen extracts containing 50% glycerine and preserved with 0.4% phenol with their strength expressed in Protein Nitrogen units (PNU). |
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Aqueous Allergen Extracts
Credisol Aqueous Allergen Extracts ensure better treatment in allergic rhinitis and allergic bronchial asthama, and other allergic reactions to specific environmental allergens such as pollen, dust, mites, fungal spores, insect stings etc. |
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Credisol Patch Test Allergen
Common causes of allergic contact dermatitis include lipsticks, cosmetics, hairdyes, necklaces, wrist watches, bracelets, industrial gloves, detergents, footwear etc. |
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