Page 146 - CW E-Magazine (3-10-2023)

Pharmaceuticals Pharmaceuticals

EXCIPIENTS TESTING SERVICES

Nitika Pharma inaugurates new microcrystalline Eurofi ns opens biopharma services centre in

cellulose plant in Nagpur Hyderabad

Nagpur-based excipient company, Global major in testing services,
Nitika Pharmaceuticals Specialities, Eurofi ns, has inaugurated its biopharma
recently inaugurated a new micro- services centre in Genome Valley, Hy-
crystalline cellulose (MCC) manu- derabad.
facturing facility at Butibori, Nagpur.
The company said the facility, with The centre is the Belgium-based
an installed capacity of 1200 metric company’s second biopharma ser-
tons, is the country’s largest MCC vices campus in India after Benga-
manufacturing plant. luru, and will provide services in
discovery chemistry and discovery
The inauguration was attended biology, safety toxicology, bioanaly-
by eminent personalities including tical services, and formulation de-
Mr. Nitin Gadkari, Union Minister Road velopment to global pharmaceutical
Transport and Highways and Mr. companies. Inaugurating the centre,
Devendra Fadnavis, Deputy Chief Mr. K. T. Rama Rao, Telangana
Minister, Maharashtra. Minister for Information Technology,
Electronics and Communications,
Speaking at the inauguration cere- Industries and Commerce, said, ”As “We identifi ed Hyderabad and, in years. The Rs. 150-crore, 15-acre cen-
mony, Mr. Gadkari noted the fact that part of their ambitious growth plans, particular, Genome Valley as an attrac- tre contains 100,000 sq ft of laboratory
the company is fi rst excipient manu- Eurofi ns will be investing signifi cant tive place to invest because of the eco- and offi ce space. It employs about 100
facturing company to receive benefi ts sums of money and create further system existing in the city, and the ease scientists and the number would ‘multi-
under the government’s Production employment opportunities from this of doing business. We have been par- ply’ going forward, he added.
Linked Incentive (PLI) scheme. Over campus over the years”. ticularly impressed by the collabora-
a period of fi ve years, the company is tion we have had with the Government Mr. Rajiv Malik, Director, Eurofi ns
expecting to create over 750 jobs with In India, Eurofi ns, through Eurofi ns of Telangana to make this investment, Advinus, said, ”The Hyderabad cam-
investment of Rs. 125-crores under the Advinus, provides services to pharma- and believe Hyderabad will be a strate- pus shall be expanded to become the
PLI scheme. Dr. Ravleen Singh Khurana, Managing Director, Nitika Pharma ceutical and agrosciences companies gic location for Eurofi ns in our global showcase site for Eurofi ns in India,
economy under Prime Minister The company’s major products for their R&D needs. ”This new state- biopharma services network,” he added. encompassing services across the com-
Mr. Gadkari said that the new Narendra Modi’s vision of self- reliant include MCC (sold under the brand of-the-art biopharma services campus According to Mr. Garg, the Hyderabad plete pharma R&D value chain from
excipient plant which will cater to over India,” he added. Dr. Ravleen Singh Tabcell), magnesium stearate (Tab- reaffi rms Eurofi ns’ commitment to in- centre will eventually become the discovery to development to GMP test-
90 countries and will not only reduce Khurana, Managing Director, Nitika lube) and Sodium stearyl fumarate vest in India,” said Mr. Neeraj Garg, largest in India for the company with ing, both for small molecules and large
import dependence for excipients but Pharma, said that the new facility (Novalube). The company is also Regional Director, Eurofi ns. additional investments in two to three molecules.”
also boost exports going forward. symbolises the company’s commit- planning to set up two more manufac-
“This will also pave India’s way to- ment to quality, innovation, and turing facilities for excipients besides PLANT INSPECTION
wards growing as the third largest sustainable manufacturing practices. enhancing research capabilities.
Aurobindo’s Andhra plant gets USFDA observation
Cipla’s InvaGen site gets 5 USFDA observations Aurobindo Pharma said the US Pradesh from September 13-19, 2023, with US FDA to close the observation at
health regulator has issued a ‘Form 483’ the Hyderabad-based drug major said the earliest,” Aurobindo Pharma stated.
Mumbai-based Cipla has said that “The inspection was a routine cur- in Form 483,” Cipla said in a stock with one observation after inspecting a in a regulatory fi ling. As per the USFDA a ‘Form 483’ is
the United States Food and Drug rent Good Manufacturing Practices exchange fi ling. The US site inspec- formulation production facility of its issued to a fi rm’s management at the
Administration (USFDA) had inspected (cGMP) inspection and a Pre-Appro- tion was from September 11th to 19th, unit in Andhra Pradesh. The US Food At the end of the inspection, a ‘Form conclusion of an inspection when the
InvaGen Pharmaceuticals Inc.’s site in val Inspection (PAI) for a site transfer 2023. There are no repeat or data and Drug Administration (US FDA) in- 483’ was issued with one observation investigator has observed any condi-
the US and made fi ve regulatory obser- product within InvaGen. On conclu- integrity observations, it said, adding spected the Unit IV of APL Healthcare which is procedural in nature, it added. tions that may constitute violations of
vations. InvaGen Pharmaceuticals is a sion of the inspection, InvaGen has that they were working with the USFDA Ltd., a wholly-owned subsidiary of the “We will respond to the US FDA within the Food Drug and Cosmetic (FD&C)
wholly-owned subsidiary of Cipla. received fi ve inspectional observations to address the issue. company, in Tirupati district of Andhra the stipulated timelines and work closely Act and related Acts.

146 Chemical Weekly October 3, 2023 Chemical Weekly October 3, 2023 147

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