Delivering High Quality Affordable APIs To The World Market
APIs
(UNIT 1)
US DMF USFDA
CEP / ASMF EDQM
TGA Australia
WHO-GMP India
US DMF USFDA
CEP / ASMF EDQM
TGA Australia
COFEPRIS Mexico
KOREAN FDA
SFDA China*
WHO-GMP India
*Application Filed
US DMF USFDA
CEP / ASMF EDQM
TGA Australia
COFEPRIS Mexico
KOREAN FDA
SFDA China
WHO-GMP India
US DMF USFDA
CEP / ASMF EDQM
TGA Australia
COFEPRIS Mexico
KOREAN FDA
WHO-GMP India
US DMF USFDA
CEP / ASMF EDQM*
TGA Australia
COFEPRIS Mexico
KOREAN FDA
WHO-GMP India
*Application Filed
US DMF USFDA
CEP / ASMF EDQM*
WHO-GMP India
*Application Filed
US DMF USFDA
CEP / ASMF EDQM
WHO-GMP India
US DMF USFDA
CEP / ASMF EDQM*
WHO-GMP India
*Application Filed
US DMF USFDA
CEP / ASMF EDQM*
WHO-GMP India
*Application Filed
US DMF USFDA
CEP / ASMF EDQM
WHO-GMP India
Regulatory Filings In 2023 – 24
Glycopyrronium Bromide
Mirabegron
Pipeline Products
Articaine HCl
Tetracaine Base/HCl
APIs
(UNIT 2)
Steroids
Grade – IP/BP/EP/USP
WHO-GMP/GMP – Approved
Written Confirmation – Received
CEP – Applied
JDMF/AFM No. – 230MF10161
Korea
Grade – IP/BP/EP/USP
WHO-GMP/GMP – Approved
Grade – IP/BP/EP/USP
WHO-GMP/GMP – Approved
Written Confirmation – Received
CEP – Applied
Grade – IP/BP/EP/USP
WHO-GMP/GMP – Approved
Written Confirmation – Applied
Grade – IP/BP/EP/USP
WHO-GMP/GMP – Approved
Written Confirmation – Received
Grade – IP/BP/EP/USP
WHO-GMP/GMP – Approved
Written Confirmation – Received
Grade – IH
WHO-GMP/GMP – Approved
Hormones
Grade – IP/BP/EP/USP
WHO-GMP/GMP – Approved
Written Confirmation – Received
Grade – BP/EP/USP
WHO-GMP/GMP – approved
written confirmation – Received
Grade – BP/EP/USP
WHO-GMP/GMP – approved
written confirmation – Received
Grade – IP/IH
WHO-GMP/GMP – approved
written confirmation – Received
Grade – IP/BP/EP/USP
WHO-GMP/GMP – approved
written confirmation – Received
Grade – IP/BP/EP/USP
WHO-GMP/GMP – approved
written confirmation – Received
Grade – BP/EP
WHO-GMP/GMP – approved
written confirmation – Received
Grade – BP/EP/USP
WHO-GMP/GMP – approved
written confirmation – Received
Grade – BP/EP/USP
WHO-GMP/GMP – approved
written confirmation – Received
Grade – IP/BP/EP
WHO-GMP/GMP – Approved
Written Confirmation – Received
Grade – BP/EP
GMP – Approved
Written Confirmation – 2023-24