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The manufacturing site of Pithampur, Madhya Pradesh, has been approved by UKMHRA, SAMCC, TGA for solid dosage forms and sterile ophthalmic solutions. The site also has ISO - EN3485 certification for medical devices. The site is targeting USFDA inspection by June, 2006.
The site manufactures a number of dosage forms such as:-
- Tablets and Capsules - Uncoated / Film Coated / Sugar Coated tablets with High Shear Granulations, Flame Proof Area for handling solvent based granulations.
- Low RH (10%) based products in segregated block.
- Sterile Solutions in Blow-fill-seal technology, 5 ml to 15 ml packs, unit dose as well as multi-dose.
- Sterile Injectables - Capability of aseptic filling and terminal sterilization, 5ml - 20 ml vials
- Cytotoxic injectables with lyophilization capability - dedicated block under execution stage.
- Packaging of pharma products in alu-alu blisters , HPDE containers, bulk drums.
Develop and manage artworks for over 200 SKUs.
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