Details 483 observations: Dr. Reddy's got 5 observations at CTO III. FDA audit held between 5 march to 9 march

FDA audit was held between 5 march to 9 march at CTO III. Dr. Reddy's got 5 483 observations. Click  here for more details

The U. S. drug regulator is conducting a surprise audit at Alkem Laboratories Ltd.’s largest facility in Daman

The U. S. drug regulator is conducting a surprise audit at Alkem Laboratories Ltd.’s largest facility in Daman, Gujarat, two people aware of the development told BloombergQuint requesting anonymity.

Great news: Sun Pharma gets US FDA nod for its specialty psoriasis drug Ilumya

Sun Pharmaceutical Industries, India’s largest drug maker, Wednesday said it got US FDA approval for its much awaited psoriasis drug Ilumya.

Audit report:Cipla Says Eight Observations By U.S. FDA For Goa Unit Are Procedural

Cipla Ltd. received eight observations regarding manufacturing practices at its Goa plant that contributes a quarter of the drugmaker’s sales in the U.S.

Dr Reddy’s Laboratories declines 3% on Form 483 from USFDA

The company has received Form 483 with 4 observations for its API Hyderabad Plant 1 at Jinnaram Mandal, Medak Telengana from USFDA.

'Female mosquito' found by USFDA in Aurobindo Pharma's facility during inspection

US Food and Drug Administration officials found a 'large female mosquito' in a facility of Aurobindo Pharma during inspection, which, according to them, was not 'free of infestation by rodents and other insects'.

The US FDA had issued nine observations after inspection of the drug maker's Unit 4 formulation facility near here last month.

The audit was conducted between February 12-20.

US FDA finds rodents and other insects at Aurobindo Pharma

During an inspection of Aurobindo Pharma’s manufacturing facility here, the US Food and Drug Administration found it to be infested with rodents and other insects, its staff poorly trained and its equipment not well maintained. The audit was conducted on February 12 and 20.

Audit report:Dr Reddy's Laboratories got 5 observations from USFDA for Medak unit

The US Food and Drug Administration has issued a Form 483 with five observations for company's Medak unit in Telangana.

These observations are related to procedures and facility maintenance. "We will address them comprehensively within the stipulated time," it said.

Audit report:Panacea Biotec clears US FDA inspection for Baddi formulation facility

Panacea Biotec on Friday said it has received Establishment Inspection Report (EIR) from US FDA for its Baddi formulation facility in Himachal Pradesh, indicating a formal closure of the inspection.

Audit report: USFDA issued Nine 483s to Aurobindo Unit-4

USFDA issued Nine 483s to Aurobindo Unit-4

Dr Reddy's gets EIR from USFDA for Srikakulam plant

Pharma major Dr Reddy's today said it has received the establishment inspection report (EIR) from the US Food and Drug Administration for its its formulations facility in Srikakulam, Andhra Pradesh.

Audit report: Sun Pharma Gets Three Observations From U.S. FDA For Halol Plant

Sun Pharmaceutical Industries Ltd. said that the U.S. drug regulator issued a Form 483 with three observations after its inspection of the Halol facility in Gujarat.

Warning letters to Indian pharma companies from US FDA declining: Study

Investment in automation, staff training and collaboration with regulators has resulted in Indian pharmaceutical plants receiving less than a third of US Food and Drug Administration warning letters in 2017. In 2015 the share of Indian sites receiving warning letters was 50%.

Audit report: Biocon gets 6 observations from USFDA for Malaysia facility

Biotechnology major Biocon Ltd on Wednesday said the US health regulator has made six observations after inspecting its Malaysia manufacturing facility.

Sun Pharma recalls over 17.5 K bottles of nasal spray from US

Sun Pharmaceutical Industries Inc, the US arm of domestic drug major Sun Pharma, is recalling over 17.5 thousand bottles of antihistamine Azelastine HCl nasal solution from the American market, latest enforcement report of the US health regulator has said.

Audit report: Natco Pharma rallies 6% on zero observations for Mekaguda unit post USFDA inspection

Natco Pharma shares rallied as much as 6.4 percent in morning Monday after the Mekaguda facility received zero observations from the US health regulator.

Audit report:Indoco Remedies' Goa plant: Here are 8 observations made by US FDA

Exclusive access to the form 483 issued to Indoco Remedies' Goa plant by the US FDA. Inspection held between 15/1/2018 to 19/1/2018. Click here to get detail information

Audit report: USFDA completes inspection of Natco's Mekaguda API facility with zero observations

Natco Pharma Limited is pleased to announce successful completion of regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, which was conducted during the period 12th February, 2018 to 16th February, 2018. The regulatory audit resulted in zero observations (no form 483 issued).

USFDA audit report: FDA Form 483 shows Pfizer repeating same mistakes

Pfizer said several weeks ago that the FDA had updated the status of its troubled Kansas fill-finish plant, paving the way for drug approvals, and sure enough this week Novartis announced an FDA nod for its

Why Dr Reddy's recalls 80,000+ bottles of Atorvastatin from US?

Dr Reddy's Laboratories has initiated voluntary recall of over 80,000 bottles of its drug Atorvastatin Calcium Tablets 10mg, 20mg and 40mg from the US market due to quality concerns.