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Results For "Official-Action-Indicated"

22 News Found

Glenmark receives OAI communication from US FDA
Drug Approval | August 24, 2022

Glenmark receives OAI communication from US FDA

The company continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest

Sun Pharma gets OAI from USFDA for Halol facility
Drug Approval | August 18, 2022

Sun Pharma gets OAI from USFDA for Halol facility

The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved

Latest Stories

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial

Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

White Papers

Chasing Consistency: Centralizing operations data is the key to optimizing chemicals plants

Implementing a digital transformation in chemical operations to maximize profitability

The complexity of compliance

The Sprint to the Summit: Unlocking Lab Efficiency through Digital Transformation

The guiding role of fluidized and spouted bed technologies in particle building processes

Interviews
Only 4-5 Indian pharma companies have a strong presence in Russia, opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Only 4-5 Indian pharma companies have a strong presence in Russia, opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
Companies must shift from L1 costing to Life Cycle Cost Analysis: Abhilash Pasham, Associate GM - Central Engineering & Projects, Dr. Reddy's Laboratories
Companies must shift from L1 costing to Life Cycle Cost Analysis: Abhilash Pasham, Associate GM - Central Engineering & Projects, Dr. Reddy's Laboratories

Packaging