clotrimazole Vaginal tablets 100 mg
Dossier type
CTD
Dossier status
Ready to file
Country of origin
Vietnam
GMP approvals
WHO
Manufacturer #21050
This CTD dossier owner and manufacturer is a leading pharmaceutical manufacturer with a strong history dating back to 1976. It specializes in a wide range of products, including prescription medications (tablets, granules, powders, suspensions), topical preparations (creams, ointments, solutions), ophthalmic preparations, and non-beta lactam cephalosporin antibiotics. They also produce health foods, cosmetic products, and wine. The company holds GMP certifications from ASEAN, WHO, GLP, and GSP for various production lines, including those for creams, ointments, solutions, and oral dosage forms. They are ISO 9001:2000 certified and have received Good Distribution Practices (GDP) certifications. The company has a significant presence in the EU and North America, with export markets expanding to include Nigeria and Cuba. Their commitment to quality and innovation is reflected in their numerous awards and accolades, including prestigious labor medals and emulation flags from government bodies and health unions.
Clotrimazole
Clotrimazole (antifungal medication) is used in the treatment of vaginal yeast infections, oral and diaper thrush, diaper and skin rashes, and various types of Ringworm such as jock itch.
It's often available without prescription in various dosages such as a topical or ointment cream, vaginal suppository, and a topical cream. The prescription is required to purchase it as an oral lozenge, troche, or troche. It is used to treat vulvovaginal Candidiasis (yeast infection) and yeast infections of skin.
How does Clotrimazole work?
Clotrimazole can inhibit the growth of specific Candida or fungal cells. It does this by altering permeability of the fungal wall. It binds directly to the cell membrane, inhibits the biosynthesis ergosterol and the other sterols necessary for cell membrane production. It might slow fungal growth, or even cause death of fungal cells. It can also be mixed with a glucocorticoid such as betamethasone to create a cream for tinea corporis. In spite of the fact that FDA endorsed, clotrimazole-betamethasone mix cream isn't the favored treatment for dermatophyte diseases because of expanded incidental effects from the skin glucocorticoid. Combination creams should be avoided to improve treatment outcome, reduce skin atrophy and cost. It is sometimes effective for treating chronic paronychia. Monotherapy, which is the best treatment for tinea infection, is recommended. Negative side effects of taking the medicine by mouth include nausea or itching. Skin side effects that can be experienced when it is applied include burning and reddening. It can still be used to treat yeast infections in pregnant ladies and is considered safer than antifungals.
Pricing of Clotrimazole
The cost of its topical cream 1% is around $11 for a supply of 14 grams. It is sold under the brand name Lotrimin, among others such as Canesten, Mycelex, Clotrimazole-3, etc.
Sourcing of Clotrimazole Manufacturers and Suppliers
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