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APIs

Antibiotic & Antibacterial APIs

Penicillin, cephalosporin, macrolide, aminoglycoside and other antibacterial drug substances for formulation, development and reference use.
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Antibacterial APIs remain a large share of generic manufacturing, and Indian producers supply many of them to the world market. This sub-category lists bulk drug substances from several antibiotic classes. They include the penicillins Amoxicillin and Ampicillin, the macrolide Azithromycin, the aminoglycoside Amikacin Sulphate, and cephalosporins such as Cefixime Trihydrate, Cefotaxime Sodium and Cefpodoxime Proxetil, plus the preservative Bronopol.

Beta-lactam products are made in dedicated facilities to prevent cross-contamination, which matters if you plan to handle them in a shared plant. Buyers should also state whether a sterile or non-sterile grade is needed, since injectable cephalosporins such as cefotaxime are supplied sterile for parenteral use. Specify the pharmacopoeia, potency requirement and particle size on your enquiry.

APIs ship in sealed, double-lined fibre drums or HDPE containers, protected from moisture. Each consignment includes the manufacturer's COA and an SDS. Import rules for antibiotics differ by country, so share your licence details when you send a request for quotation.

Antibiotic & Antibacterial APIs: questions buyers ask

Why must beta-lactam APIs be handled separately?
Penicillins and cephalosporins can trigger serious allergic reactions at very low levels. Regulators therefore expect them to be made and handled in segregated areas to prevent cross-contamination of other products. If your plant processes beta-lactams, plan dedicated equipment and air handling before receiving material.
Do you offer sterile antibiotic APIs?
Some antibiotics used in injections, such as cefotaxime sodium and other cephalosporin salts, are available in sterile grades from approved manufacturers. Sterile grades carry extra testing for sterility and endotoxins. Tell us the intended dosage form so we can confirm whether a sterile or non-sterile grade fits your product.
How is antibiotic potency reported?
Potency is usually stated as micrograms of active per milligram on the anhydrous basis, or as a percentage assay against the pharmacopoeial reference. For some antibiotics, such as aminoglycosides, a microbiological assay may be used. The COA shows the method and result so you can calculate the quantity needed in your formula.

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