Pharma GMP Newsletter

18-10-2019

US FDA EIR to Lupin for Nagpur facility

 

Lupin Limited received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Nagpur facility. Inspection of the facility was done by the US

17-10-2019

Torrent Pharma red flagged by USFDA for violating norms for Indrad Facility

 

Torrent Pharma is now red flagged by USFDA for significant violations of current good manufacturing practice (cGMP) regulations for its Indrad facility in Gujarat.

An inspect

13-10-2019

Torrent Pharma recalls 74k bottles of hypertension drug from US

 

As per the reports of the US health regulator, Torrent Pharma Inc is recalling 73,896 bottles of hypertension treatment tablets from the US and Puerto Rico on the basis of deviations

10-10-2019

USFDA observations to Aurobindo Pharma's Unit-VII regarding potentially misleading documents

 

An inspection has been conducted by the US Food and Drug Administration officials in a manufacturing facility of Aurobindo Pharma. The FDA has observed several discrepancies regardin

09-10-2019

GMP certification for Lupin's unit-2 Mandideep facility by Japan's PMDA

 

Good manufacturing practice (GMP) certificate has been received by Lupin from Japan's Pharmaceutical and Medical Devices Agency (PMDA) for its drug manufacturing facility at Mandidee

08-10-2019

FDA Warning Letter for Refusal to Permit Inspection: Important parameters for Startups and Drug and Device Manufacturers

 

Current Good Manufacturing Practices (cGMPs) are mandatory enforced by regulators of the U.S. Food and Drug Administration (FDA), and must be executed and followed by manufacturers o

05-10-2019

Mandideep facility of Lupin red-flagged by USFDA for CGMP violations

 

Lupin, a pharma firm was red flagged by the US health regulator for significant violations of the current good manufacturing practice regulations at its Mandideep facility in Madhya

22-09-2019

USFDA cGMP surveillance clearance of Unichem Labs API facility in Kolhapur

 

Unichem Laboratories has successfully completed the US health regulator audit of its new facility at Kolhapur, Maharashtra without any observations.

The cGMP surveillance of

10-09-2019

USFDA warning letter to Hangzhou Badi Daily Use Chemical Company

The U.S. Food and Drug Administration (FDA) conducted an inspection of Hangzhou Badi Daily Use chemical company, drug manufacturing facility located at Huzhou City, Zhejiang Province from March 19

10-09-2019

Enprani Co., Ltd. Gets USFDA warning letter

Enprani Co., Ltd drug manufacturing facility located at Incheon, was inspected by the U.S. Food and Drug Administration (FDA) from March 11 to 15, 2019.

The warning letter was issued to com

03-09-2019

Haw Par Healthcare Limited receives USFDA warning letter

USFDA inspection was done at Haw Par Healthcare Limited drug manufacturing facility located at Singapore, from February 25 to March 1, 2019.

Issued warning letter summarized the significant

27-08-2019

EMA cGMP certification to Viralgen

The Viralgen receives the European Medicines Agency (EMA) cGMP compliance accreditation certificate and Spanish Agency for Medicines and Health Products (AEMPS) Pharmaceutical Laboratory authorizat

27-08-2019

Open-ended AGES GMP certification wins by Rentschler Fill Solutions

The Austrian Agency for Health and Food Safety (AGES) has given the GMP compliance and pharmaceutical manufacturing license to the Rentschler Fill Solutions. It is a contact development and manufac

27-08-2019

Three US FDA observations to Ipca Labs for Silvassa facility

The US FDA inspection for Silvassa facility of Ipca Labs conducted during 19-23 August 2019. It is the formulation facility of Ipca Labs.

The firms receive three US FDA observations in Form

27-08-2019

Three US FDA observations to Ipca Labs for Silvassa facility

The US FDA inspection for Silvassa facility of Ipca Labs conducted during 19-23 August 2019. It is the formulation facility of Ipca Labs.

The firms receive three US FDA observations in Form

14-08-2019

New Q&A’s added by FDA to lab control section-cGMP guidance

Three new questions and their answers are added by the USFDA to the laboratory Controls on Current Good Manufacturing Practices (cGMP) guidance. The instrument calibration standards, trial injectio

12-08-2019

API facility of Natco Pharma gets 6 observations from the USFDA

The API facility based in Mekaguda Village, near Hyderabad receives six observations from the USFDA. The inspection was carried out between05-09 August 2019.

The received observations are m

10-08-2019

Strides Alathur facility completes USFDA inspection with no observations

The Alathur facility of Strides based in Chennai has successfully completed the USFDA audit with zero observation. The inspection was done between 05August to 09August 2019 with no observation from

05-08-2019

Lupin receives FDA EIR for Aurangabad facility
The USFDA has issued Establishment Inspection Report (EIR) for Lupin's Aurangabad facility. The USFDA inspection was carried out during 6 May 2019 till 15 May 2019.
 

04-08-2019

Manufacturing violations observed at Emcure Pharma Pune Plant: USFDA

The US FDA has issued a warning letter to Emcure Pharma for its Pune based plant. It was made due to violation of current good manufacturing practices (cGMP) by the organization.

The US FDA

01-08-2019

Cadila Healthcare completes USFDA audit with zero observation

The USFDA has done the audit of Cadila Healthcare’s facility based at Ankleshwar in Gujarat. The facility is involved in the manufacturing of active pharmaceutical ingredients.

The US

31-07-2019

Vials for hemophilia treatment recalled by Bayer due to mislabeling

After the fear of mislabeled vials, Bayer has voluntarily recalled 2 lots of 2000 IU vials (recombinant) containing Kogenate FS antihemophilic factor in the United States. Even though the labels in

29-07-2019

Granules India’s inspection with one USFDA observation

Granules India completes the USFDA audit of its Bonthapally facility with one observation. It is amongst the world’s largest single site manufacturing plant of Paracetamol API by volume. The

23-07-2019

Patients are advised not to use Herbal Doctor Remedies’ Medicines

The FDA has recommended that the patients should not use the drugs manufactured by Herbal Doctor Remedies, Monterey Park, California, because the conditions at the manufact