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us food and drug administration (usfda)

  1. H

    Marksans Pharma Expands Generic Portfolio with USFDA Approval

    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...
    • Himanshu
    • Thread
    • abbreviated new drug application (anda) benzonatate bioequivalence bronchitis treatment cough treatment generic drug approval lung infections marksans pharma non-narcotic antitussive pfizer inc. pharmaceutical industry pneumonia treatment tessalon capsules therapeutic equivalence us food and drug administration (usfda)
    • Replies: 0
    • Forum: Business
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    Lupin's Generic Drug for Daytime Sleepiness Receives USFDA Review

    Lupin Receives Tentative USFDA Approval for Generic Pitolisant Tablets New Delhi, March 25 – 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...
    • Himanshu
    • Thread
    • 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 us food and drug administration (usfda)
    • Replies: 0
    • Forum: Business
  3. K

    Cipla Recalls Anti-Cancer Drug Nilotinib Due to Manufacturing Issue

    Cipla’s US Arm Recalls Over 400 Cartons of Generic Anti Cancer Drug Nilotinib: USFDA Manufacturing Issue Triggers Recall of Nilotinib Capsules in Two Strengths New Delhi, March 8: Cipla’s US-based subsidiary has recalled more than 400 cartons of a generic anti cancer medication from the United...
    • Karthik
    • Thread
    • anti-cancer medicine cancer treatment cipla generic medicine generics market india manufacturing issue nilotinib pharmaceutical industry pharmaceutical manufacturing pharmaceutical recall sun pharmaceutical industries united states us food and drug administration (usfda) warren, new jersey
    • Replies: 0
    • Forum: Business
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    Alkem Laboratories Receives USFDA Form 483 with Six Observations After Chakan Facility Inspection

    USFDA Concludes Pre Approval Inspection at Enzene Biosciences Unit New Delhi, February 16: Alkem Laboratories on Monday said the United States health regulator has issued a Form 483 with six observations following an inspection of the manufacturing facility of its wholly owned subsidiary Enzene...
    • Karthik
    • Thread
    • 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 us food and drug administration (usfda)
    • Replies: 0
    • Forum: Order & deals
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