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Zydus Cadila gets US FDA nod to market generic HIV treatment tabs expressbpd
November 19, 2018
The product will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad
US FDA grants Lynparza Orphan Drug Designation for pancreatic cancer biospectrumasia
October 17, 2018
Press Release Lynparza AstraZeneca Merck & Co. FDA Pancreatic Cancer Regulatory Affairs
JB Chemicals and Pharmaceuticals gets US FDA nod for Panoli facility financialexpress
May 21, 2018
JB Chemicals and Pharmaceuticals said that the US health regulator has completed the inspection of its Panoli facility in Gujarat with two minor observations.
US FDA introduces patent submission date updates to Orange Book expressbpd
November 23, 2017
The FDA is publishing this data to improve transparency and provide additional information to regulated industry and the public
Ajanta Pharma receives US FDA approval for clonidine hydrochloride extended release tablets expressbpd
November 22, 2017
Ajanta Pharma, announces today US FDA approval and launch of Clonidine Hydrochloride Extended Release Tablets in the US Market through its wholly owned subsidiary Ajanta Pharma USA Inc.
Cipla receives US FDA approval for generic Pulmicort Respules expressbpd
November 20, 2017
The drug is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age
Laurus Labs gets EIR from US FDA for AP plants expressbpd
November 15, 2017
Laurus Labs has received Establishment Inspection Report (EIR) from the US Food and Drug Administration(US FDA) for its API (active pharma ingredients) plants located at Visakhapatnam in Andhra Pradesh.
Lupin gets US FDA approval for testosterone topical solution expressbpd
October 26, 2017
Drug firm Lupin has received the final approval from the US health regulator for its testosterone topical solution.
Aurobindo Pharma gets US FDA nod for heartburn drug expressbpd
October 18, 2017
Aurobindo Pharma has received final approval from the US health regulator to manufacture Esomeprazole Magnesium delayed-release capsules, used in treatment of frequent heartburn, in the US market.
Glenmark gets US FDA nod for Aprepitant nausea capsules expressbpd
October 17, 2017
The tablets are generic versions of Merck Sharp and Dohme Corporation’s Emend capsules

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