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Results For "Abbreviated-New-Drug-Application"

287 News Found

Lupin enters into BTA with Lupin Manufacturing Solutions
News | October 17, 2023

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution
Drug Approval | October 13, 2023

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch

Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Drug Approval | October 07, 2023

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)

Alembic received 6 USFDA approvals during Q2FY24
Drug Approval | October 05, 2023

Alembic received 6 USFDA approvals during Q2FY24

The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets

Briefs: Caplin Steriles, Zydus and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients

Lupin receives USFDA approval for Pirfenidone Capsules
Drug Approval | August 31, 2023

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US

Lupin receives approval from USFDA for Pirfenidone Tablets
Drug Approval | August 28, 2023

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals
Drug Approval | August 24, 2023

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets
News | August 23, 2023

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets

Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Lupin receives approval from USFDA for Bromfenac Ophthalmic
News | August 20, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).

Latest Stories

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

FUJIFILM India unveils four new imaging & healthcare IT solutions at IRIA 2026

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