Feb 21, 2017 at 21:10 | Source: PTI
Drug firm Dr Reddy's Laboratoriestoday said the US health regulator has made three observationsafter completing inspection of its Miryalaguda facility.
Feb 21, 2017 at 17:36 | Source: PTI
Glenmark Pharmaceuticals today said it has received four observations from the US health regulator for its Ankleshwar facility after inspection in December 2016.
Feb 21, 2017 at 16:09 | Source:
The Unit-11 plant produces non-antibiotic active ingredients, is used for both the captive purpose of Aurobindos formulation manufacturing and for supplies to external customers.
Feb 21, 2017 at 11:58 | Source:
Marksans Pharma, on February 20, announced that it has successfully completed UK MHRA inspection for its Goa facility without any critical observations. The company is now awaiting further instruction from the agency on the way forward
Feb 17, 2017 at 15:29 | Source:
Biocon shares gained 2.6 percent to hit a record high of Rs 1,123 after the US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim.
Feb 17, 2017 at 14:50 | Source: PTI
US health regulator USFDA hasaccepted pharma major Mylan's biologics licence application(BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim,Biocon and Mylan have said.
Feb 17, 2017 at 14:26 | Source: PTI
Drug firm Zydus Cadila has received approval from the US health regulator to market fluconazole tablets used for the treatment of fungal infections.
Feb 17, 2017 at 13:00 | Source:
Sun Pharma gained for second consecutive session, up 2.75 percent on hopes of early USFDA clearance to its Halol facility, especially after Cadila did not get any observations for its Moriaya facility. Wockhardt also rose 3 percent.
Feb 17, 2017 at 11:00 | Source:
Cadila Healthcare extended its rally, up 4 percent on top of 20 percent surge in previous session as its Moriaya facility did not receive any observations from USFDA post inspection.
Feb 17, 2017 at 10:30 | Source:
Brokerage firms and analysts tracking the stock welcomed the development and most have raised the target price. To be sure a lot of them were expecting resolution of the warning letter on Moraiya facility in the fourth quarter of FY17.
Messages on Usfda »


New Member



, by the United States Food and Drug Administration (USFDA), has been completed on February 21, 2017," Dr Reddy`s Laboratories said in a filing to BSE. The company has been issued a Form 483 with three observations, which is being addressed, it added. According to FDA, "Form 483 is issued to firm management

10.48 PM Feb 21st


Gold Member


Dr Reddys Labs  

fall of 10-15 percent coming tomorrow for sure...form 483 is issued with two violation of usfda

10.17 PM Feb 21st


New Member



Add by SIP way for long good profit if USFDA clears

5.32 PM Feb 21st


New Member

0 Follower

Aurobindo Pharm  

BIG news fro AUROBINDO - sources Unit 11 (2nd largest API plant supplying to US) inspection completed today with zero observations by USFDA it will move like cadila did. buy it soon

3.03 PM Feb 21st


New Member

0 Follower

Aurobindo Pharm  

news for AUROBINDO - sources Unit 11 (2nd largest API plant supplying to US) inspection completed today with zero observations by USFDA

2.56 PM Feb 21st


New Member


Aurobindo Pharm  

aurobindo`unit no.11 cleared by usfda with not 1000 tgt is achievable. all the best.happy investing.another pharma stk is granules which got funding from world bank for expansion,so tgt of 500 is intact in granules as well.

2.27 PM Feb 21st


New Member


Sun Pharma  

sun pharma: as per media alert, german health authority has cleared sun pharma s kharkhadi (under usfda import alert) and dahej units by issuing gmp certification positive for sun pharma; usfda clearing halol and kharkhadi unit will be key trigger to watch for. the stock is currently trading

1.27 PM Feb 21st


Feb end 800/_ hoo to Bhai ganga Naha , idiot no upper down trends here, only for wait usfda approval after buy now this amount invested in FD

11.55 AM Feb 21st


Platinum Member


Marksans Pharma  

GMP-certified Good Manufacturing Practice , when all restrictions are removed), Marksans reacted positively but due to various reasons again lost its glory. This time, after regaining cGMP from UKMHRA (It is already USFDA approved- Goa), one 20% UC is due for more. I see it 90-95/- in Q-2, FY-18.

11.10 PM Feb 20th


Gold Member



has 8 state of the art manufacturing plants and has licensing alliances with global multinationals including Schering AG, Boehringer Ingelheim, and Viatris. 4) With recent resolution of USFDA on Cadila`s Moraiya facility being critical to the company onward success for further developments

9.46 PM Feb 20th

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