Azithromycin 200 mg/5 ml Powder for Suspension | Formulation & Manufacturing Process

Azithromycin is an antibiotic medication used for the treatment of several bacterial infections. This includes middle ear infections, strep throat, pneumonia, traveler’s diarrhea, and certain other intestinal infections. Along with other medications, it may also be used for malaria. It can be taken by mouth or intravenously.

Azithromycin was discovered in 1980 by the Croatian pharmaceutical company Pliva and approved for medical use under the brand name Sumamed in 1988. It is on the World Health Organization’s List of Essential Medicines. The World Health Organization classifies it as critically important for human medicine. It is available as a generic medication and is sold under many trade names worldwide. In 2020, it was the 68th most commonly prescribed medication in the United States, with more than 10 million prescriptions.

There are several dosage forms and strengths available with Azithromycin. The most common of which is Azithromycin 200 mg/5 ml Powder for Suspension.

Each 5 ml reconstituted suspension contains Azithromycin 200 mg as Azithromycin Dihydrate USP. The formulation & manufacturing process of Azithromycin 200 mg/5 ml Powder for Suspension is as below:

Formulation:

Each 5 ml reconstituted suspension contains:

Sl	Name of Ingredient(s)	Specification	Quantity	Function
Active Ingredient(s)
1	Azithromycin 7.5% w/w Taste Masked Granules with Banana Flavor	USP	200.00 mg (Equivalent to Azithromycin 2.67 gm as Azithromycin Dihydrate USP)	Active Substance

* The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process:

1. Azithromycin Taste Masked Granules weighed accurately.
2. Send the sample to the QC department for analysis
3. After getting QC approval fill the taste mask granules in the bottles in the filling-sealing machine according to the specifications.
4. After QA approval pack in designated carton.