Mutual Funds Commodities Research Tax Planning IPO Our Team Contact Us    
Stock Report

| More

USFDA completes inspection of Natco Pharma's Kothur Formulation facility

Posted On: 2019-06-06 13:21:45

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has announced completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur Village, near Hyderabad, India, which was conducted during the period 30th May, 2019 to 5th June, 2019.

At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of observations are related to data integrity and that all of the observations can be addressed within a short period of time.

Key points of the observations in Form 483 outlined below:

- Field Alert Report (FAR) was not submitted within three (3) days of receipt of information of failure of distributed batches to meet specifications. Although the out of specifications (OOS) result was invalidated, but FAR was not submitted within three (3) days of detection of OOS.

Out of trend results of a distributed batch were not extrapolated to obtain expected impurity value at the end of shelf life.

- Annual product reviews of one of the products were not approved in time.

- Visual inspection of products carried out as a part of investigation was not properly documented.

- SOP on manual interpretation of impurity peaks was made effective in November 2018, but the interpretation of impurity peaks performed prior to November 2018 were not reviewed for appropriateness and accuracy.

- Retest results performed by original analyst were considered for reporting rather than average of all retest results from the original and 2nd analyst.

- Documentation of chemical surface swabbing performed per cleaning validation on one of the products provides no description of each of individual sub swabbing samples performed for each sample location.

- Master Production and control records for one of the product does not include the operational parameters of peristaltic pumps used.

- Mechanical stirrer used in the manufacturing of one of the product does not have documented range or speed verification using a calibrated tachometer.

- Standard weights used to perform daily calibration of balances, or ferrous and non-ferrous metal test pieces used during qualification of metal detector are not traceable to a unique identification code in calibration logs.

The company will provide due justifications and corrective action plan within the next fifteen (15) working days to address the USFDA observations.

Shares of NATCO PHARMA LTD. was last trading in BSE at Rs.546.95 as compared to the previous close of Rs. 532.95. The total number of shares traded during the day was 14222 in over 572 trades.

The stock hit an intraday high of Rs. 558.9 and intraday low of 524. The net turnover during the day was Rs. 7634803.

Source: Equity Bulls

Click here to send ur comments or to

Other Headlines:

Asian Granito in Fortune India's List as one of The Next Fortune 500 companies

Pantaloons Celebrates the Pujo Rockstars this Pujo with its new campaign

Indian Overseas Bank celebrates Hindi Month - 2019

Alkem Laboratories Ltd acquires undertaking from subsidiary

Sakthi Sugars Ltd agrees for OTS with Bank of India

Pidilite Industries Ltd forms subsidiary

Corporate Tax reduction - Mr. Kamlesh Patel, Chairman and Managing Director - Asian Granito India Ltd

Seamec Ltd announces extension of long term charter for SEAMEC II with HAL Offshore Ltd

Nippon Express to Acquire 22% Stake in Future Supply Chain Solutions Ltd

Hexaware's Salesforce practice has been awarded Gold Consulting Partner status

Lupin receives sANDA approval from U.S. FDA for Levothyroxine Sodium Tablets USP to be considered AB rated to Reference Listed Drug, UNITHROID®

USFDA approval for Unichem Laboratories Ltd's plant at Kolhapur

Zensar Recognized in the 2019 Gartner Magic Quadrant for Data Center Outsourcing and Hybrid Infrastructure Managed Services, North America

Asian Paints launches 'AP Homes' in Bengaluru, its state-of-the-art multi-category décor showroom

Allahabad Bank Introduces External Benchmark Linked Loans under Retail and Micro & Small Enterprises

IndiGo inaugurates flights between India and Myanmar

Strides Board approves incremental investments in Stelis

Himatsingka Seide Ltd board approves investment of Rs. 17.34 crore in wind power SPVs

AXIS Bank Ltd board to consider Q2 results on Oct 21, 2019

Bingo! Pujo Tadka enlivens the festive spirit of Durga Pujo

Just Launched: Official App for TCS Lidingöloppet 2019 Packed with Exciting New Features

Raksha Mantri inaugurates Engineers Conclave (2019), Product Development & Innovation Centre of BEL

Redington offering the latest products from Apple, including iPhone 11 Pro and iPhone 11 Pro Max

Dilip Buildcon Ltd completes road project in Punjab

Anuh Pharma Ltd successfully completes USFDA inspection

Bajaj Electricals Limited receives 2019 ASCM Corporate Award of Excellence for Advance Supply Chain Industry

Brickwork Ratings downgrades rating of Reliance Home Finance Ltd

Morgan Credits Private Limited has sold 2.3% stake in YES Bank Ltd

AXIS Bank opens QIP, fixes floor price as Rs. 661.50

Lux Industries Limited issues CPs of Rs. 50 crore

Godrej Consumer Products Ltd increases stake in subsidiaries

ICRA reaffirms ratings of Reliance Chemotex Industries Ltd

Lincoln Pharmaceuticals Ltd board approves merger of Lincoln Parenteral Ltd

Thyrocare Technologies Ltd calls for board meeting on Sep 21, 2019

Capital India Finance Ltd inks MOU with Union Bank of India for Loan Co-origination

Morepen Laboratories Ltd board approves preferential issue

Mahindra BAJA SAEINDIA 2020 Commences its 13th edition

NMDC revises prices of Iron Ore w.e.f. 19-09-2019

Speedcast and Nelco Awarded Remote Communications Contract for Leading Indian Cruise Line

Bharat Forge Ltd acquisition update regarding Refu Drive GmbH

Kolte-Patil Developers delivers strong returns to Motilal Oswal Real Estate from its City Avenue Project

Astral Poly Technik Limited allots 3,01,32,441 bonus shares

Surya Roshni Ltd bags order of Rs.79.80 crore

TCS a Leader in Software Product Engineering Services: Everest Group

Thomas Cook India observes an impressive 21% growth in demand during Durga Puja

Now buy Detel TVs and connected essentials in IndiGo flights

TVS Motor Company launches TVS NTORQ 125 Race Edition

IDBI Bank board approves preferential issue to Government and LIC

1 millionth Maruti Suzuki car exported from Gujarat's Mundra Port

Mindtree Opens New European Headquarters in London

Website Created & Maintained by : Chennai Scripts
West Mambalam, Chennai - 600 033,
Tamil Nadu, India

disclaimer copyright © 2005 - 2019