USFDA

Aurobindo Pharma gets USFDA nod for anaesthetic injection

Aurobindo Pharma has received final nod from the US health regulator to manufacture and market its anaesthetic Bupivacaine Hydrochloride injection in the American market.

Aurobindo Pharma gets USFDA nod for anaesthetic injection

Lupin shares tank over 10% intraday in today’s trade, here is why

In the past one year, share price of Lupin tanked 25.21 per cent to Rs 1495.10 till March 28, whereas the benchmark index Nifty Pharma index slipped 13.73 per cent during the same period.

Lupin shares tank over 10% intraday in today’s trade, here is why

Natco Pharma shares slip over 12% on USFDA observations, should you buy?

Natco Pharma shares tumbled over 12 per cent on Monday after the company on Sunday said it has received “minor” observations by US Food & Drug Administration

Natco Pharma shares slip over 12% on USFDA observations, should you buy?

Torrent Pharma gets establishment nod from US FDA

The plant located at Dahej SEZ, in Gujarat, has also received approval from EU Germany Torrent Pharma said its third manufacturing plant in Gujarat has obtained the Establishment Inspection Report (EIR) from the US health reg

Aurobindo Pharma gets USFDA nod for generic Tranexamic acid injection

Aurobindo Pharma has received final approval from the USFDA to manufacture and market its Tranexamic acid injection, used for treating hemophilia, in the American market. The company plans to launch the product by the end of

Aurobindo Pharma gets USFDA nod for generic Tranexamic acid injection

USFDA makes 9 observations over Wockhardt’s plant in Aurangabad

The USFDA has made nine 'observations' highlighting violations of its norms at homegrown drug maker Wockhardt's new facility at Shendra in Aurangabad.

USFDA makes 9 observations over Wockhardt’s plant in Aurangabad

Cadila Healthcare receives warning letter from US FDA

The letters were received for its two facilities in Gujarat Cadila Healthcare has received a warning letter from the US Food and Drug Administration (US FDA) for its two facilities in Gujarat. “The company has received

Dr Reddy’s submits response to USFDA over warning letter

Last month, the country's second-largest drug maker, Dr Reddy's, had received a warning letter from the USFDA relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana.

Dr Reddy’s submits response to USFDA over warning letter

USFDA gives Dr Reddy’s additional time to respond to warning letter

Dr Reddy's Laboratories Ltd (DRL) today said the USFDA has extended the time-frame for replying to the warning letter issued to the company by about two weeks to December 7.

USFDA gives Dr Reddy’s additional time to respond to warning letter

Sun Pharma withdraws suit filed by Ranbaxy against USFDA

Drug major Sun Pharmaceutical has withdrawn its appeal in the lawsuit filed by Ranbaxy against the US health regulator challenging FDA's decision to revoke approvals for generic versions of Nexium and Valcyte.

Sun Pharma withdraws suit filed by Ranbaxy against USFDA

Jubilant Life Sciences shares gain on receiving USFDA approval for Indomethacin ER Capsule

Jubilant Life Sciences shares gained as much as 3.5 per cent intraday on Wednesday after the company informed BSE that it has received approval from the US health regulator to market Indomethacin capsule used for treating pai

Jubilant Life Sciences shares gain on receiving USFDA approval for Indomethacin ER Capsule

US FDA approves Bionomics’ cancer drug

The drug targets hard-to-treat colorectal and pancreatic cancers, but may also prove suitable to treat breast, lung and other tumours A new class of drug that reduces cancer recurrence and spread may soon be available, with S

USFDA issues warning to Pan Drugs for GMP violations

US health regulator has issued a warning to Gujarat-based Pan Drugs over "significant deviations" from good manufacturing norms at its Vadodara plant.

Glenmark Pharmaceuticals gets USFDA nod for fungal infections treatment drug

Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for Voriconazole Tablets, used to treat fungal infections.

Glenmark Pharmaceuticals gets USFDA nod for fungal infections treatment drug

Aurobindo Pharma shares gain over 3% on key drug approvals

Aurobindo Pharma shares over 3 per cent in the early trade on Monday on BSE after the company on August 29 said it has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ralox

Aurobindo Pharma shares gain over 3% on key drug approvals

Dr Reddy’s Laboratories recalls anti-seizure, hypertension drugs from US market

Dr Reddy's Laboratories has started recalling Divalproex Sodium extended-release tablets as it has failed dissolution tests, and Amlodipine Besylate and Atorvastatin Calcium tablets since these are close to expiry time.

Dr Reddy’s Laboratories recalls anti-seizure, hypertension drugs from US market

US FDA warns over 1,000 illegal online medicine sellers

Also seizes illegal drugs and medical devices sold through these websites

Aurobindo Pharma receives USFDA approval for Metronidazole tablets

Metronidazole tablets are used to treat different types of infections

Strides Arcolab receives ANDA approval from US FDA

Product to be launched immediately Strides Arcolab has received approval from the United States Food & Drug Administration (USFDA) for Lamivudine and Zidovudine tablets USP, 150 mg/300 mg. According to IMS data, the US ma

US FDA, DCG(I) explore more ways to work together

Willing to collaborate with Indian regulators, other stakeholders: US FDA

End of Wockhardt’s Chikalthana USFDA woes?

No major findings from recent USFDA inspection, after 2013 import alert on the company's Aurangabad-based Waluj and Chikalthana facilities

IPA, Pharmexcil organises technical conference

The theme for the conference was ‘USFDA- Steps for Sustained Compliance’

Ranbaxy sues US FDA

Asks for temporary restraining order

USFDA issues warning letter to Cadila Pharmaceuticals

The US Food and Drug Administration has issued a warning letter to Ahmedabad-based Cadila Pharmaceuticals...

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