Pharma GMP Newsletter

11-03-2020

Cadila's Baddi unit was furnished with USFDA Form 483 with zero observations

 

Cadila Healthcare Limited declared that US Food and Drug Administration (FDA) furnished Form 483 with zero observations to the Baddi unit of the company.

09-03-2020

Hyderabad facility of SMS Pharma clears USFDA inspection

 

SMS Pharmaceuticals has successfully completed its Hyderabad’s testing facility regulatory inspection by the US drug regulator.

The United States Fo

02-03-2020

FDA issues warning letter to manufacturing facility of KVK-Tech

 

The US Food and Drug Administration (FDA) have issued a warning letter to drug manufacturing facility of KVK-Tech following an audit in April 2019.  

29-02-2020

Aurobindo Pharma receives EIR from USFDA for Hyderabad facility

 

Aurobindo Pharma Limited stated that it has gained the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAI) status from US Food and Drug Administrati

29-02-2020

API Manufacturing Facility for Biocon Small Molecules Completed its Post -Approval and GMP USFDA Inspectionq

 

Biocon, a drug API maker, has announced that the U.S. Food and Drug Administration (FDA) performed a Post-Approval and GMP inspection of Small Molecules API Manufacturing F

28-02-2020

Jadcherla facility of Shilpa Medicare receives 15 observations from USFDA

 

Shilpa Medicare has got 15 observations from US Food and Drug Administration (FDA) for the finished dosage formulation facility (sterile and non-sterile) for Jadcherla faci

24-02-2020

USFDA concluded evaluation at Puducherry & Mangaluru facilities of Solara

 

A leading active pharmaceutical ingredient (API) provider, Solara Active Pharma Science Ltd., declared that the US Food and Drug Administration (FDA) have done two successf

24-02-2020

USFDA retracted status of VAI for Unit-IV plant of Aurobindo Pharma

 

The US Food and Drug Administration (FDA) revoked the status of ‘Voluntary Action Initiated’ (VAI) furnished to Unit-IV plant of Aurobindo Pharma in Hyderabad.<

24-02-2020

Alkem Labs Baddi facility receives 2 USFDA observations

 

Alkem Laboratories Limited has achieved 2 observations from US Food and Drug Administration (FDA) for the facility in Baddi of company in Himachal Pradesh.

23-02-2020

EU GMP Annex 1: 2nd Draft on Sterile Manufacture

 

A 1st targeted consultation to the Annex 1 of the EU GMP Guide permitted about 140 companies and organizations to comment. The drafting group moved ahead with more than 620

22-02-2020

Reopening of investigation by USFDA of unit 4 facility of Aurobindo

 

Reopening of investigation of Aurobindo Pharma’s Unit-4 manufacturing facility by the US Food and Drug Administration, days after the regulator had declared that it h

22-02-2020

Biocon receives three observations from USFDA for insulin facility in Malaysia

 

Biocon on Saturday stated that it has gained 3 observations from the US health regulator following inspection of its facility of insulin manufacturing in Malaysia.

The US Foo

22-02-2020

FDA Warning Letter for getting drugs which are potentially unsafe

 

The U.S. Food and Drug Administration (FDA) have furnished a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for getting drugs which are po

22-02-2020

As per the Warning Letter, FDA criticizes Supplier Qualification

 

Supplier Qualification and the respective contracts in outsourcing activities are always hot debated topics in inspections. The U.S. Food and Drug Administration (FDA) rece

11-02-2020

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

27-01-2020

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

16-01-2020

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

14-01-2020

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.

13-01-2020

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

11-01-2020

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.

A PAI

06-01-2020

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

21-12-2019

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

19-12-2019

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

19-12-2019

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

13-12-2019

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

25-11-2019

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

15-11-2019

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

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