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REGULATORY COMPETENCY

Lupin's Regulatory Affairs department is experienced in handling regulatory requirement of multiple markets.

They are updated on the recent trends of the industry which is evident from the high number of DMFs available in CTD format across markets.

The regulatory department works in tandem with R&D right from the start, which ensures development "Right First Time" (RFT) in compliance with various emerging requirements like QbD and detailed genotoxic evaluation.

Integration of our Regulatory Affairs team with Technology Transfer; QA & QC teams facilitates smooth transfer/scale up from Lab to Manufacturing.

This enables Timely and Speedy launch with Lupin's API while minimizing regulatory queries and response turnaround time.

Types No Of DMF's Filed
Total DMF filed 267
USDMF 152
Canada 20
AU DMF 28
JDMF 8
EDMF 48
KDMF 11
COS 21

− No critical observations in last 10 MHRA audits and in last 8 WHO audits

− No 483s in last 5 FDA audits as on Dec’14