Ipca Labs gets warning letter from US FDA for three plants
The manufacturing units are located at Ratlam, SEZ Indore and Piparia
Drug firm Ipca Laboratories has received warning letter…
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Browsing Tag
US FDA
DRL receives US FDA approval for treatment of acute migraine episodes
ZEMBRACESymTouch is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan
US…
Waters products manufactured as per US FDA and CE-Marked standards
Waters Corporation announced that the Waters Acquity UPLC I-Class IVD/Xevo TQ-S micro IVD System is now manufactured as a US FDA…
US FDA observations for Shendra facility not critical: Wockhardt
According to the company, half of the issues will be resolved in next fortnight
The nine observations received by Wockhardt for…
Aurobindo Pharma gets US FDA approval for norethindrone acetate tabs
The tablets are used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary…
SMS Pharma gets US FDA approval for Andhra unit
The US FDA conducted plant inspection in the third week of April 2015
SMS Pharmaceuticals has received approval from the US FDA…
Aurobindo Pharma receives US FDA approval for allergic conjunctivitis solution
The approved product has an estimated market size of $235 million
Sun Pharma receives warning letter for Halol facility
The company expects a re-inspection by US FDA
Sun Pharmaceutical Industries has received a warning letter from the US FDA as a…
Aurobindo Pharma receives USFDA approval for methylprednisolone sodium succinate injection
The approved product has an estimated market size of $102 million for the twelve months ending October 2015 according to IMS…
US FDA approves first emergency treatment for overdose of certain types of chemotherapy
An overdose of fluorouracil or capecitabine is rare, but when it occurs, the effects are serious and can be fatal
The US Food and…