At Onika, we have state of art manufacturing facility to produce Sterile Lyophilized (Bulk) API (Active Pharmaceuticals Ingredients) (Antibiotics, Corticosteroids, Proton Pump Inhibitors, Antifungal, Anti-Malarial and Antiviral) with Micronization facility. The facility meets all regulatory compliances like US FDA, EU GMP & Revised Schedule M.

Lyophilized Bulk API
(Active Pharmaceutical Ingredients)

About Technology

Lyophilization Technology originating from Leybold Germany (GEAGERMANY).

About Regulations

All the major manufacturing and testing equipments are 21 CFR compliant.

About Team

Onika has team with vast experience in developing, scaling & validating Lyophilization cycles to produce quality products with consistency.

About Environment

PNG based steam generator installed to avoid the environment pollution. Proper Bio-Hazardous & general waste management is in place to avoid the environment pollution.

About Design

Facility is designed as per quality by design (QBD) approach to ensure the consistent delivery of high quality product. Facility is designed in such a way that can there are no chances of contamination of the product. All major manufacturing equipments are integrated with the provisions of automatic CIP (Cleaning in Place) and SIP (Sterilization in Place) system. Facility is dedicated to general category of API. All the rooms are designed with clean room sandwich panels. Transfer of materials in the critical areas is through the dynamic pass boxes and we have installed automatic PTS (Powder Transfer System) to avoid human contamination & assurance of product sterility.

Our Product List

S. No.

Product Name
Corticosteroid

1.

Prednisolone Acetate

2.

Methyl prednisolone Acetate

3.

Methyl prednisolone Sodium Succinate

4.

Betamethasone Acetate

5.

Hydrocortisone Sodium Succinate
Proton pump inhibitor

6.

Omeprazole Sodium

7.

Esomeprazole Sodium

8.

Pantoprazole Sodium

9.

Rabeprazole Sodium

10.

Lansoprazole Sodium
Antibiotics

11.

Azithromycin

12.

Teicoplanin

13.

Doxycycline

14.

Clarithromycin

15.

Colistimethate Sodium

16.

Vancomycin Hydrochloride

17.

Polymyxin B Sulphate (Micronized)

18.

Ketoprofen

19.

Tenoxicam
Muscle Relaxant

20.

Vecuronium Bromide
Antifungal

21.

Voriconazole

22.

Amphotericin B
Anti-malarial

23.

Artesunate
Chelating Agent

24.

Deferoxamine mesylate
Antiviral

25.

Acyclovir Sodium