|NAME OF THE PRODUCT
|Ciprofloxacin Taste masking granules
|Azithromycin Taste masking granules
|Clarithromycin Taste masking granules
A) Readymix is supplied in bulk packing of 10/25/40 kgs the pharmaceutical company after analyzing the content shall fill it as per requirement in the suitable bottle / packing. eg:-
1) Ciprofloxacin Taste masked powder of ciprofloxacin 18.75% is supplied in 25 kgs hdpe drums so in case a pharma company requires a dosage of 250 mg per and 12 such dosage to be filled in a bottle of 60 ml then as per the calculation they will be required to fill 16 gms with appropriate overages in each bottle.
2) Azithromycin Taste masked powder of azithromycin 7.5% is supplied in 25 kgs hdpe drums so in case a pharma company requires a dosage of 200 mg per 5 ml and 3 such dosage to be filled in a bottle of 15 ml then as per the calculation they will be require to fill 8 gms with appropriate overages in each bottle.
A) The reconstitution is to be done by the user as follows:-
1) Ciprofloxacin (for 60 ml bottle wherein 16 gms of taste masked ready mix has been used and each 5 ml contains 250 mg / 5 ml of ciprofloxacin) Use boiled and cooled water to make up the volume to the 60 ml mark shake well for 2 minutes till a proper suspension is formed add more water to make up the volume and shake gently the suspension is ready to use.
2) Azithromycin (for 15 ml bottle wherein 8 gms of taste masked readymix has been used and each 5 ml contains 200 mg per 5 ml of azithromycin) Use boiled and cooled water to make up the volume to the 15 ml mark (10 ml water will be required to make up the volume to 15 ml hence water for injection 10 ml can be also given) shake well for 2 minutes till a proper suspension is formed add more water to make up the volume and shake gently the suspension is ready to use.
A) In case of azithromycin the MOA to be followed is as per USP or any other pharmacopeial standard or the current method being used by the customer for testing the product .In case the customer still request we can offer them our customized MOA.
Similarly in case of ciprofloxacin either the customer may follow the std method as given in pharmacopeia or the method they might be using or we can provide them with our customized MOA.
A) These kind of products are available internationally as under by different manufactures under different brand names.
Azithromycin for oral suspension is available under brand name ZITHROMAX by PFIZER.
Ciprofloxacin for oral suspension is available under brand name CIPRO by BAYER.
A) We can offer material from our factory which has local (Indian) FDA approved has GMP certification . In case any customer requires WHO approved facility we can provide the same from our sister concerned.
A) 1) We can offer them all the necessary open part documents required for registration which includes the following:-
b) Certificate of analysis with necessary chromatograms.
c) Method of analysis.
d) Stability data.
2)) We can also offer the following data after signing of secrecy agreement and a firm business commitment:-
a) Qualitative formula
b) Moa of each ingredient which has been used
c) Tentative method of manufacture
d) List of equipment.
A) Yes, we can do it, but generally the trend is to purchase the unflavored and uncolored product from us and flavor is as per requirement in that particular country, of course we are always there to guide our customers if required in their quest for best product.