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Cromoglicate manufacturers

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cromoglicate

Eye drops 2%

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
EU GMP
Manufacturer #11554
It is the leading pharmaceutical company specializing in ophthalmic products. The company has acquired EU GMP certification and has been under preparation for CGMP approval for both manufacturing sites of multi-dose and single-dose products.

Manufacturer usually replies in 6 days

CROMOGLICATE

Cromoglicic acid also referred to as cromolyn or Cromoglicate is a mast cell stabilizer. It prevents the release of histamine, an inflammatory chemical, from mast cells. It is commonly marketed as sodium cromoglicate or cromolyn sodium. In the treatment of Asthama, it was the non-corticosteroid of choice but has been replaced by leukotriene receptor antagonists, as they are known to be safer and convenient to use. It has no additive benefit when taken in combination with inhaled corticosteroids. Cromoglycate is an effective long-term prophylactic when treating mild-to-moderate asthma, where it decreases the frequency and severity of attacks in extrinsic and exercise-induced asthma, in younger patients. It has also shown symptomatic improvement when used to treat Allergic rhinitis, as a nasal spray. As eye drops, it used to treat allergic conjunctivitis. Cromoglicate is sold under the brand names Cromolyn sodium, Catacrom®; Murine® hayfever relief; Opticrom®; among others. Roger Altounyan first discovered Cromolyn sodium in 1965. It is a breakthrough drug in asthma management. It frees many of them from depending on steroids. However, do note that it is mainly effective as a prophylaxis for allergic or exercise-induced asthma. It should not be for or during acute attacks.

Dosage and administration

Cromoglicate is ingredient in several medicines, so the dosage and the form and the availability vary. In the case of the eye drops, wash your hand first, remove the cap using a single-dose unit. Then tilt your head back and let the drops fall into the eye. To release one drop into your eye, Press the container gently. After administration, Close eyes for a two minutes, and press gently on the side of your nose where the corner of your eye meets your nose.

The cost of Cromoglicate

In India, the consumers have to pay USD0.50 to USD1 for 5ml ophthalmic solution. In the USA, the cost of 20 mg/2ml is $2.36 per nebule for 50 nebules.

How does Cromoglicate Work?

Cromoglicate prevents the release of mediators that attract inflammatory cells, thus stabilizes the inflammatory cells. MCT mast cells in the mucosa are stabilised. The underlying mechanism of action is not fully understood. While Cromoglicate stabilizes mast cells, it is not associated with curing asthma. However, it has been suggested that, it works by inhibiting the response of sensory C fibers to the irritant capsaicin, which in turn inhibits the local axon reflexes involved in asthma. It is also thought to inhibit the release of preformed T cell cytokines and mediators associated with Asthama.

Finding CROMOGLICATE Manufacturers and Suppliers:

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