As already disclosed by Company in its earlier communications, and in view of the changed pharmaceutical market situation in the United States, the management had initiated various cost optimisation measures, including restructuring its USA business model, inter alia, by closing down its manufacturing facility in Illinois, USA and undertaking its business in USA through Contract manufacturing the products sold by it in US/North America by engaging USFDA approved manufacturing partners meeting the superior quality standards acceptable to the Company.
In line with the above, the Company has now engaged multiple USFDA approved manufacturing partners, after thorough due diligence and inspection of their facilities, to manufacture various products of the Company for sale in US/ North America under the same brand and Wockhardt name. Further, the Company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner and in full compliance with the applicable local laws.
The Company believes, that this new arrangement is in the best interest of the Company as this will help the Company to avoid the manufacturing and quality management cost completely resulting in significant savings in operating and overhead cost while allowing the management to completely focus on penetrating and expansion of the market share of its products in US/ North America.
In view of the above and since the concerned site was under 483 observations and warning letters from US FDA, the Company has entered into a Consent Decree with DoJ which resolves and settles all matters with the US FDA, whereby the Company shall stop all manufacturing activities at the plant for the present. There is no financial compensation in the Consent Decree.
The management emphasizes that the above closure of the manufacturing unit will not affect the availability of its products in the US market in view of the alternate arrangement already put in place and on the contrary allow the Company to grow more vigorously in the US market.
Kindly take this information on record.
Thanking you,
For Wockhardt Limited
Debashis Dey
Company Secretary
ANNEXURE A
Disclosure of Information pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 read with the SEBI Circular No. CIR/CFD/CMD/4/2015 dated September 9, 2015
Sr. No.
Particulars
1.
Details and reasons for restructuring;
As disclosed above.
2.
Quantitative and/ or qualitative effect of
As disclosed above.
restructuring;
3.
Details of benefit, if any, to the
None.
promoter/promoter
group/group
companies
from
such
proposed
restructuring;
4.
Brief details of change in shareholding
None.
pattern (if any) of all entities.
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Wockhardt Limited published this content on 20 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 August 2022 09:35:04 UTC.
Wockhardt Limited is a pharmaceutical and biotechnology company. The Company's businesses include manufacture and marketing of pharmaceutical and bio-pharmaceutical formulations, active pharmaceutical ingredients (APIs) and vaccines. It manufactures a range of dosage forms, including sterile injectables and lyophilized products. The Company offers products in therapeutic areas of dermatology, cosmeceuticals, oncology, medical nutrition, osteoarthritis, pain management, nephrology, cough therapy and diabetology. The Companyâs products across India includes Citawok, Citawok Forte, Citawok Plus, CONSEGNA 30/70 U-200 CART, CONSEGNA R U-200 CART, DARBOTIN PFS, DECDAN, DECDAN B, DECDAN B Injection, DECDAN LITE CREAM, Emrok, Emrok O, Erliso, FOSCHEK-S, Gabawok NT, GLARITUS CART, GLARITUS DISPO, Glimaday, INOGLA, Livatira, GLARITUS CART and VAL 450. It has manufacturing and research facilities in India, United States of America and the United Kingdom and a manufacturing facility in Ireland.