Alapati Pharma
Alapati Pharma is an ISO 9001:2015 & CGMP certified company with the state of art manufacturing facility. The manufacturing process adhere to stringent specification of CGMP and compliant with WHO-GMP regulation.
SALIENT FEATURES
- Plant/ Facility has been renovated and redesigned to maintain unidirectional men and material movement as per CGMP.
- Temperature, Relative humidity, and pressure differentials in production areas are maintained and monitored.
- All the manufacturing area walls are painted with Epoxy based PU paint, all corners and wall joints were epoxy coved, flooring with granite and epoxy joints.
- Standalone AHUs (Air Handling Units) for manufacturing areas, Dehumidification Units and Dust Extraction Systems.
- Core areas are installed with terminally mounted HEPA Filters.
- Relative Humidity in manufacturing areas can be maintained as low as 20%.
- Materials transfer from primary areas to secondary areas through Dynamic Pass boxes.
- Pressure differentials are maintained with respect to adjacent areas to avoid cross contamination.
- The purified water distribution loop confirming to USP Standards.
- Adherence to Standard Operating Procedures ( SOPs ) and Training Schedules
- Isolated and dedicated production facilities for Tablets and Capsules, Beta-Lactam Products, liquid orals.
- Latest machineries and equipment to meet utmost quality standards in each and every aspect to reach better quality of products to customers.
- In-house testing facility for raw material analysis / In process checks / Finished product analysis.
- Developed formulation for all the Potassium Clavulanate Group of products, where in south India we find limited number of manufacturers who are expertise in Clavulanate Group.
Production Capacity:
Beta-Lactum
Tablets: 1,00,00,000 Per Shift / Month
Capsules: 25,00,000 Per Shift / Month
Non Beta-Lactum
Tablets: 2,00,00,000 Per Shift / Month
Capsules: 25,00,000 Per Shift / Month
Liquid Orals
Bottles: 1,50,000 Per Shift / Month