WHO-GMP Formulations & Dossiers

Sterile Injectable & Lyophilized Dry Powder Vials Manufacturer in India

Akuma Enterprise Pharma operates advanced aseptic manufacturing suites for sterile small-volume parenterals (SVP), lyophilized dry powder antibiotic vials, and liquid injectable ampoules for critical care and hospital procurement.

Direct Answer Summary: Akuma Enterprise Pharma manufactures sterile injectables and cephalosporin dry powder injection vials in a dedicated WHO-GMP parenteral facility in India. Products include Ceftriaxone, Cefoperazone + Sulbactam, Amikacin, and Diclofenac ampoules packaged with Sterile Water for Injection (WFI) for hospital tenders and emergency medicine supply.

Aseptic Cleanroom Technology & Lyophilization

Injectable production demands total sterility assurance (SAL 10^-6). Our parenteral facility incorporates isolator barrier systems, automated vial washing, depyrogenation tunnels operating at 300°C, and Grade A laminar airflow filling stations with 100% automated optical inspection for particulate matter.

Commercial Injectable Product Range

Our commercial parenteral offerings include:

Ceftriaxone Sodium Injection (250mg, 500mg, 1g): Sterile lyophilized dry powder vial with Sterile Water for Injection (WFI).
Cefoperazone Sodium & Sulbactam Sodium (1.5g): Critical care antibiotic vial for severe nosocomial infections.
Amikacin Sulphate Injection (100mg, 250mg, 500mg): Ready-to-use liquid parenteral in USP Type I glass ampoules.
Diclofenac Sodium 75mg/1ml: High-solubility transdermal pain relief ampoules.
Methylcobalamin & Multi-B Complex Injections: Therapeutic neurotropic injection ampoules.

Frequently Asked Questions

Are Sterile Water for Injection (WFI) ampoules included with dry powder vials?

Yes. Every dry powder injection vial can be supplied as a complete combi-pack with a 5ml or 10ml sterile plastic or glass WFI ampoule.

What type of glass is used for parenteral packaging?

We exclusively utilize USP Type I neutral borosilicate glass vials and ampoules to prevent chemical leaching and delamination.

What sterility testing protocols are performed prior to batch release?

Every parenteral batch undergoes 14-day membrane filtration sterility testing (IP/BP/USP), bacterial endotoxin testing (LAL test), and particulate matter testing per USP <788>.

Partner with Akuma Enterprise Pharma

Connect with our commercial export and contract manufacturing desk for product catalogs, custom batch pricing, and immediate eCTD dossier review.

sales@akumaenterprises-pharma.com dalle@akumaenterprises-pharma.com

Direct Contact: +91 07986147827 · Akuma Enterprise Pharma Pvt. Ltd. · SAS Nagar, Punjab - 140301, India.