New Delhi, April 1 Marksans Pharma Ltd announced on Wednesday that it has received final approval from the US health regulator for its generic version of Benzonatate capsules, indicated for the treatment of persistent cough, bronchitis, pneumonia, or other lung infections.The approval from the...
New Delhi, March 25 Pharma major Lupin Ltd announced on Wednesday that it has received tentative approval from the US health regulator for its generic version of Pitolisant tablets, indicated for the treatment of excessive daytime sleepiness.The tentative approval from the US Food and Drug...
abbreviated new drug application
drug development
drug manufacturing
excessive daytime sleepiness
generic pharmaceuticals
healthcare
india
lupin ltd
nagpur
pharmaceutical approval
pharmaceutical industry
pitolisant
regulatory filings
tablet
usfoodanddrugadministration (usfda)
New Delhi, March 8 A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).Cipla USA, Inc, based in Warren (New Jersey), is recalling Nilotinib Capsules in...
anti-cancer medication
cancer treatment
cipla
cipla usa, inc
class iii recall
drug supply
generic medication
manufacturing defect
nilotinib
pharmaceutical industry
pharmaceutical manufacturing
pharmaceutical recall
usfoodanddrugadministration (usfda)
us prescription drugs
warren (new jersey)
New Delhi, February 28 Zydus Lifesciences announced on Saturday that it has received approval from the US health regulator to market generic anti-parasitic and leprosy medications.The company has received final approvals from the US Food and Drug Administration (USFDA) for Ivermectin Tablets...
New Delhi, February 27 Drug maker Lupin announced on Friday that it has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing facility in Goa.The company stated that it has received the EIR with a satisfactory Voluntary Action Indicated (VAI)...
New Delhi, February 16 Alkem Laboratories said on Monday that the US health regulator has issued a Form 483 with six observations after inspecting the manufacturing unit of its wholly-owned subsidiary, located in Chakan.The US Food and Drug Administration (USFDA) completed a pre-approval...
alkem laboratories
bse
chakan
data integrity
drug firm
enzene biosciences
fd&c act
form 483
india
manufacturing unit
pharmaceutical industry
pharmaceutical manufacturing
quality systems
regulatory inspection
usfoodanddrugadministration (usfda)
New Delhi, February 14 Piramal Pharma has stated that the US health regulator has issued a Form 483 with four observations after inspecting its manufacturing plant based in Telangana.The US Food and Drug Administration (USFDA) conducted an inspection of the company's plant in Digwal...
New Delhi, February 10 Drug maker Cipla said that the US health regulator has issued Form 483 with two observations after inspecting a manufacturing facility of its US-based unit, InvaGen Pharmaceuticals, Inc.A Pre-Approval Inspection was conducted by the US Food and Drug Administration...