Pharma GMP Newsletter


US FDA inspection at Panoli, Gujarat facility completed successfully of J. B. Chemicals & Pharmaceuticals Ltd


J. B. Chemicals & Pharmaceuticals Ltd’s US FDA granted solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat has successfully completed p


Form 483 to Biocon's API facility: USFDA


A pre-approval inspection and good manufacturing practice examination was conducted by the US health regulator at the API manufacturing facility of Biocon. The company has received a


FDA furnishes warning letter to Health Pharma for violations of cGMP


The US Food and Drug Administration (FDA) has issued a warning letter to Health Pharma regarding its manufacturing site in New Jersey, US, after violations of current good manuf


Multiple manufacturing units of Lupin now under USFDA scanner


Drug major manufacturing capabilities of Lupin have come under the scanner of the US drug regulator, as it has located deficiencies across multiple sites in recent inspections.


USFDA categorizes inspection of Tarapur facility of Lupin as Official Action Indicated


Lupin Ltd on Monday stated the US health regulator has alerted that its Tarapur manufacturing facility may be subjected to regulatory actions.

The company has obtained a comm


Lupin receives two observations from USFDA for Nagpur facility


Lupin, a drug firm on Saturday stated that it has obtained two observations from the US health regulator following the inspection of its Nagpur manufacturing facility.



GPT Pharma obtains US FDA warning for violations of cGMP at Hyderabad plant


The United States Food and Drug Administration (FDA) has furnished warning letter to drug firm GPT Pharmaceuticals for important violations of current good manufacturing practice (cG


EIR secured from USFDA by Pashamylaram facility of Suven Life Sciences


Suven Life Sciences Limited recently received the EIR following the renewal inspection by US health regulator at their facility in Pashamylaram near Hyderabad for the supply and


LifeSan Clinical Research obtains zero 483 observations from USFDA


A division of Centaur Pharmaceuticals Pvt Ltd, LifeSan Clinical Research has obtained zero Form 483 observations from US Food and Drug Administration (FDA). The company has unde


Baddi manufacturing unit of Glenmark obtains GMP certificate from European regulator


Glenmark Pharmaceuticals Ltd has obtained Certificate of good manufacturing practice (GMP) from European drug regulator for its Baddi unit in Himachal Pradesh. Glenmark's Baddi


Zero observation obtained by Hikal from US FDA for Panoli facility


Hikal Ltd has successfully completed USFDA audit at Panoli, Gujarat, with zero Form 483 observations.

The inspection was conducted between September 9 and 1


Torrent Pharma warned by USFDA for significant violations at US plant


The US health regulator has warned Torrent Pharmaceuticals’ US-based subsidiary for violating good manufacturing practices, including the unavailability of properly designed eq


USFDA found cGMP violations were found by at Cadila’s Moraiya plan


Vital violation of current Good Manufacturing Practice (cGMP) regulations was found by the health regulator of US for finished pharmaceuticals at Cadila Healthcare’s Morai


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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.


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.



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


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


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


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