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Aravali API Sciences Pvt. Ltd.
Unit II — Ankleshwar, Gujarat
API Manufacturer
ICH Q7EU GMP Part IISchedule MFDAPIC/S
Products
Metformin HCl APIAtorvastatin Calcium API
2 products·1 Approved·1 In Progress
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FG Formulations Pvt. Ltd.
Unit I — Baddi, Himachal Pradesh
OSD Manufacturer
FDA (ANDA)EU GMPSchedule MUSPBPIP
Products
Metformin HCl 500mg TabletAtorvastatin 10mg TabletAmlodipine 5mg TabletPantoprazole 40mg
7 products·2 Approved·3 In Progress
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BioNova Biologics Pvt. Ltd.
Unit III — Genome Valley, Hyderabad
Biosimilar / Biologics Manufacturer
FDA 351(k)EMA BiosimilarCDSCO-BSI 2016ICH Q5A–Q5EICH Q6BWHO TRS 977
Products
Adalimumab 40mg/0.8mL PFSTrastuzumab 440mg LyoBevacizumab 400mg/16mLRituximab 500mg/50mL
7 products·2 Approved·4 In Progress
Regulated manufacturing quality — Annual Product Quality Review — engineered for API, OSD and biosimilar manufacturers.