| Certificate Number |
CDRR-CGMP-1060
|
| Manufacturer |
INTAS PHARMACEUTICALS LIMITED
|
| Plant Address |
PLOT NUMBERS 457, 458 & 191/218P, SARKHEJ-BAVLA HIGHWAY, MATODA, SANAND, AHMEDABAD, GUJARAT, IN-382210, INDIA
|
| Importer |
SINGAPORE GENEBIO, INC.
|
| Validity Date |
31 December 2023
|
| Type of Application |
RENEWAL
|
| Product Line |
1. Sterile*,**
1.1. Aseptically prepared
1.1.1. Lyophilisates
1.1.2. Small volume liquids
1.1.3. Others: Pre-filled syringes 1.2. Terminally sterilized
1.2.1. Small volume Liquids
1.2.2. Others: Pre-filled syringes
2. Non-sterile*
2.1. Hard capsule
2.2. Tablets
*Sterilization of active substances/excipients/finished products: Filtration, Moist heat; Primary and Secondary packaging; Quality control testing: chemical/physical and microbiological: sterility and non-sterility
**Including products for Oncology
The Clearance refers to OSD I, OSD II, External Preparations, Central QC, Oncology QC, General Parenteral, Oncology Solid dose & Oncology Parenteral.
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