Home » » » » Sun Pharma temporary pause in release of batches from Mohali until US FDA mandated measures are implemented

Sun Pharma temporary pause in release of batches from Mohali until US FDA mandated measures are implemented

Sun Pharma has received a letter titled “CONSENT DECREE CORRESPONDENCE/NON-COMPLIANCE LETTER” from the US FDA. US FDA has directed the Company to take certain corrective actions at the Mohali facility before releasing further final product batches into the US. These actions include, among others, retaining an independent CGMP expert to conduct batch certifications of drugs manufactured at the Mohali facility. The Company is taking required corrective steps, but there will be a temporary pause in release of batches from Mohali until US FDA mandated measures are implemented. US shipments from Mohali will resume once these measures are in place.

Comments

Post a Comment

Popular posts from this blog

Bharti Airtel Result Summary

ToDate Result Date  Type   EBITA YOY   Profit YOY   CI YOY   EPS YOY   EBITA QOQ   Profit QOQ   CI QOQ   EPS QOQ   Mar-2024   14-May-2024   C 4.38 -51.06 -83.71 -31.89 23.47 -28.1 413.33 -15.46 S 19.91 34.68 34.47 33.05 -6.07 28.95 28.77 28.74  Dec-2023   05-Feb-2024   C -2.76 10.05 -94.78 51.96 -23.07 37.42 -90.66 80.93 S 62.94 -143.89 -143.95 -143.41 11.25 382.73 382.69 384.31  Sep-2023   31-Oct-2023   C 29.18 -29.73 -51.92 -37.89 4.57 37.69 -136.73 -16.9 S 59.12 -69.12 -69.06 -69.64 5.56 -79.89 -79.67 -80.16  Jun-2023   04-Aug-2023   C 46.69 -38.42 -312.93 -1.39 5.09 -64.03 -192.48 -46.42 S 257.96 258.4 263.29 252.05 8.71 7.58 6.41 7.53  Mar-2023   16-May-2023   C 21.39 13.76 2.91 47.63 15.02 61.69 64.5 88.61 S 4576.38 -154.87 -154.98 -154.07 27.64 -142.03 -142.09 -142  Dec-2022   0...
Read more

Gentari signs MoUs with MoEVing, Gati to reinforce India commitment

  Collaborations with MoEVing, Gati and Tata Motors to strengthen green mobility portfolio NEW DELHI, India – 27 March 2023  – Clean energy solutions provider Gentari is maintaining its steady pace in delivering decarbonisation to key markets globally. In India, its green mobility arm is catalysing growth via a series of partnerships and investments. Gentari, through its affiliated entity Amplus Power Supply Private Limited, signed a Memorandum of Understanding (MoU) with Tata Motors, India’s largest commercial vehicle manufacturer, in 2022, whereby the latter will deliver 5,000 units of Tata Ace EV – India’s most advanced, zero-emission, four-wheel small commercial vehicle, over three years. The MoU includes delivery of 1,000 units in the first year, for deployment in cities such as Delhi, Bengaluru, Hyderabad, Pune and Kolkata. To mark the delivery of the first batch of 100 trucks throughout March and April this year, a vehicle handover ceremony was held at the 8 th  Sm...
Read more

TATAMOTORS Result Summary

ToDate Result Date  Type   EBITA YOY   Profit YOY   CI YOY   EPS YOY   EBITA QOQ   Profit QOQ   CI QOQ   EPS QOQ   Mar-2024   10-May-2024   C 85.78 218.93 106.49 221.9 21.63 145.31 46.15 147.93 S 19.74 -21.11 -17.29 -21.19 36.33 -53.47 -53.43 -53.52  Dec-2023   02-Feb-2024   C 135.17 134.8 6.08 137.61 26.25 86.46 10675.97 86.75 S 113.66 802.83 750.85 809.92 -22.42 259.95 234.11 261.21  Sep-2023   02-Nov-2023   C -469.21 -526.57 -101.06 -497.17 11.15 16.1 -98.8 17.49 S -723.42 -533.93 -726.29 -534.21 130.42 -2082.57 -18726.45 -2041.18  Jun-2023   25-Jul-2023   C -212.49 -166.67 -209.52 -163.89 8.84 -39.94 9.53 -40.82 S -584.46 -64.62 -98.53 -63.83 -50.86 -102.38 -100.29 -102.42  Mar-2023   12-May-2023   C 960.61 -654.01 2399.57 -622.59 53.97 80.6 -24.92 83.01 S 336.13 552.13 400.16 557.01 143.27 432.5...
Read more