The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
NFIL’s ambition is to reach revenues of US$100mn from CDMO by FY25.
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
Gland Pharma Q2 FY2023 consolidated net profit up at Rs. 241.24 Cr
On the Capex front, the company has invested Rs. 416 crore in the first half and it is broadly in line with our guidance for the two years around Rs. 2,000 crore across all the subsidiaries and divisions
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US
Around 62% of the revenues came from the domestic market and 38% from the exports market for Q2 FY23 for a standalone business
The acquisition of these two brands expands Lupin's portfolio of inhalation products in the U.S.
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