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Food And Drug Administration

Sep 28, 2016 at 19:08 | Source: PTI
Sun Pharmaceutical Industries Inc is recalling 12,109 bottles of Carvediol tablets USP used for treatment of high blood pressure, according to the latest Enforcement Report of the US Food and Drug Administration (USFDA).
Sep 28, 2016 at 10:49 | Source: Moneycontrol.com
Aurobindo Pharma shares gained nearly 3 percent intraday Wednesday after it received approvals from the US health regulator for three drugs, including Zoledronic filed from unit IV that inspected during the month.
Sep 27, 2016 at 11:18 | Source: Moneycontrol.com
Indoco Remedies shares fell 9 percent intraday Tuesday. The company has received Form 483 with six observations from the US health regulator for its Goa plant II and III after recent inspection, reports CNBC-TV18 quoting Anand Rathi.
Sep 23, 2016 at 15:38 | Source: PTI
The rating agency said it is also assigning the preliminary 'BB-' rating to the proposed US dollar notes to be issued by JPL.
Sep 22, 2016 at 22:19 | Source: CNBC-TV18
I am taking this as a second round of up move on anticipation of very good numbers to be seen from all of them and more specially if you need to put me in the pecking order probably I will go with Ujjivan, Capital First and then the Equitas Holding, said SP Tulsian.
Sep 22, 2016 at 13:35 | Source: Moneycontrol.com
Aurobindo Pharma is pleased to announce the tentative approval of Dolutegravir 50mg from US Food & Drug Administration (USFDA) for the treatment of HIV.
Sep 22, 2016 at 13:34 | Source: PTI
In a BSE filing, Aurobindo Pharma said it has received "tentative approval for Dolutegravir 50 mg from US Food & Drug Administration (USFDA) for the treatment of HIV.
Sep 20, 2016 at 14:58 | Source: PTI
The US Food and Drug Administration (USFDA) has placed Laxachem Organics Pvt Ltd on import alert 99-32 that allows detention without physical examination of products from firms refusing FDA foreign establishment inspection, FDA said on its website.
Sep 20, 2016 at 13:45 | Source: Moneycontrol.com
Sharon Bio Medicine shares were locked at 20 percent upper circuit at Rs 10.16 on Tuesday after the company received approval from the US health regulator for its plant based in Maharashtra.
Sep 20, 2016 at 10:02 | Source: Moneycontrol.com
Bank of America Merrill Lynch (BoAML) has maintained its buy rating on Aurobindo Pharma on expectations of strong 23 percent earnings per share (EPS) CAGR over FY16-18, especially after USFDA's successful inspection of unit IV plant at Andhra Pradesh and establishment inspection report for Penem facilities.
Messages on Food And Drug Administration »

Wiseadv-16

New Member

1 Followers

Aurobindo Pharm  

It is great news that Aurobindo received approval from US Food and Drug Administration for Levonorgestrel- Ethinyl Estradiol oral and Norethindrone tablets which means this opens up highly lucrative American & Eurpoean this will give a windfall benefits in 2017-18 onwards buy buy and hold

12.29 PM Sep 28th

shiv_analys
t

Platinum Member

513 Followers

Wockhardt  

Wockhardt as a Anand Rathi Sales Note states has received Establishment Inspection Report EIR The report is for its Chikalthana facility for its March 2015 US Food and Drug Administration FDA inspection Upon completion of inspection USFDA provides inspected establishments an inspection

9.57 PM Sep 22nd

axeumax009

New Member

10 Followers

Wockhardt  

food and drug administration (fda) form 483 with some observations in relation to products manufactured prior to execution and implementation of good manufacturing practice (gmp) remediation programme, after the us regulator conducted a 10-days inspection at chikalthana. the recent inspection

4.12 PM Sep 22nd

SaintEquity

Platinum Member

279 Followers

Wockhardt  

Aurobindo Pharma will also be on the investors` radar today as the US Food and Drug Administration (USFDA) issued 2-3 observations, following inspection at the drugmaker`s Andhra Pradesh plant

10.14 AM Sep 20th

Willwin

Platinum Member

964 Followers

Wockhardt  

This man who broke the news to CNBC kept on repeating our sources without mentioning the actual sources. "The US Food and Drug Administration (FDA) has given a clean chit to the Chikalthana plant of Wockhardt , reports CNBC Awaaz quoting sources. Official announcement from the FDA is expected

4.56 PM Sep 18th

Kalyanmitta

Platinum Member

216 Followers

Hikal  

(APIs) useful to the company’s business as well as for supply to third party customers,” it added. The US Food and Drug Administration (USFDA) approved facility would help the Bangalore-based company in vertically integrating its oncology related abbreviated new drug application (ANDA) filings

8.11 PM Sep 16th

jegurupati

New Member

20 Followers

Wockhardt  

the us food and drug administration (fda) has given a clean chit to the chikalthana plant of wockhardt, reports cnbc awaaz quoting sources. official announcement from the fda is expected in couple of weeks.

4.28 PM Sep 16th

savera_patn
a

Platinum Member

37 Followers

Biocon  

Posted 13 September 2016 By Zachary Brennan placeholder image The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each of the first new biosimilars for a reference product, though it may hold more if there are particular

10.38 AM Sep 14th

savera_patn
a

Platinum Member

37 Followers

Biocon  

Posted 13 September 2016 By Zachary Brennan placeholder image The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each of the first new biosimilars for a reference product, though it may hold more if there are particular

10.37 AM Sep 14th

STOCK PREDATOR

New Member

258 Followers

Lupin  

Food and Drug Administration (FDA). The company’s product is a generic version of Pfizer Inc’s Zithromax and is indicated for mild to moderate infections caused by bacteria. As per IMS MAT sales data, Zithromax Oral Suspension had US sales of $ 110.6 million. Lupin expects to launch nearly 25 products

11.25 AM Sep 12th

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