Amikacin 500 mg Injectable Solution bulk supplier for pharma manufacturers

Amikacin 500 Mg Injectable Solution Suppliers & Bulk Manufacturers

Available Forms: Injectable Solution

Available Strengths: 250 mg/2 mL, 500 mg/2 mL, 1 g/2 mL

Reference Brands: Amikin(Us & EU)

Amikacin inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, leading to faulty protein production and bacterial cell death. It provides rapid, broad-spectrum activity against serious gram-negative infections such as sepsis and pneumonia. Benefits include quick bacterial eradication, effective hospital use, and coverage of resistant bacteria when used properly.

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Product Description:

Amikacin IV is approved in the EU and US for serious gram-negative bacterial infections. In the EU, brands like Amikin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data; generic formulations are available. Both regions require detailed dossiers, including clinical trial results, quality assurance, and pharmacovigilance plans for approval and ongoing safety monitoring. Due to its potent antibacterial activity and potential toxicity, strict prescribing controls and monitoring are enforced. For regulatory dossier support, compliance, and registration, visit PharmaTradz. We support seamless market access aligned with European and US standards for safe, effective antimicrobial therapy.

Amikacin 500 Mg Injectable Solution — third party manufacturing & bulk supply

Amikacin 500 Mg Injectable Solution is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Amikacin 500 Mg Injectable Solution is supplied as Injectable Solution — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Amikacin 500 Mg Injectable Solution listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Amikacin injection is used to treat serious bacterial infections caused by susceptible Gram-negative organisms. These include infections of the respiratory tract, urinary tract, bones and joints, skin and soft tissues, intra-abdominal infections, septicemia, and hospital-acquired infections. It is often reserved for severe or resistant infections.

Amikacin injection is made from amikacin sulfate, a semi-synthetic aminoglycoside antibiotic derived from kanamycin. It works by inhibiting bacterial protein synthesis, leading to the destruction of bacteria.

Common trade names include Amikin, Amikacin Injection IP (generic), Amikace, Amistar, and Amipar.

Amikacin was originally marketed under the brand Amikin by Bristol-Myers Squibb. It is now manufactured by multiple pharmaceutical companies worldwide including Cipla, Sun Pharma, Lupin, and many other generic manufacturers.

The generic name is amikacin sulfate injection.

Brand names include Amikin, Amikace, Amistar, Amipar, and various other region-specific generics.

Amikacin injection is manufactured globally, with major production hubs in India, the United States, Europe, and other regions by both innovator and generic pharmaceutical companies.