Unichem in the spotlight March 4, 2021 ANDA approval from United States Food and Drug Administration (USFDA) for Unichem’s Guanfacine Tablets, USP 1 mg and 2 mg. February 19, 2021 ANDA approval from United States Food and Drug Administration (USFDA) for Unichem’s Apremilast Tablets, 10 mg, 20 mg and 30 mg. January 27, 2021 ANDA approval from United States Food and Drug Administration (USFDA) for Unichem’s Zonisamide Capsules, USP 25 mg, 50 mg and 100 mg. January 13, 2021 ANDA approval from USFDA for Unichem’s Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg August 6, 2020 ANDA approval from USFDA for Unichem’s Atenolol and Chlorthalidone Tablets August 6, 2020 ANDA Approval from USFDA for Unichem’s Tolterodine Tartrate Tablets July 22, 2020 ANDA Approval from USFDA for Unichem’s Amiodarone Tablets July 10, 2020 ANDA approval from USFDA for Unichem’s Baclofen Tablets July 7, 2020 ANDA approval from USFDA for Unichem’s Cyclobenzaprine Hydrochloride Tablets November 2, 2019 ANDA approval from USFDA for Unichem’s Atenolol Tablets USP September 20, 2019 USFDA approval for Kolhapur plant September 6, 2019 USFDA approval for Pithampur plant August 28, 2019 ANDA approval from USFDA for Solifenacin Succinate Tablets, 5 mg and 10 mg. August 26, 2019 USFDA approval for the Company’s Ghaziabad plant August 13, 2019 ANDA approval from USFDA for Unichem’s Tramadol Hydrochloride Tablets August 12, 2019 ANDA approval from USFDA for Unichem’s Chlorthalidone Tablets December 21, 2018 ANDA approval from USFDA for Unichem’s Pramipexole Dihydrochloride Tablets December 11, 2018 Tentative ANDA Approval from USFDA for, Unichem’s Tadalafil Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg. November 26, 2018 Unichem has received Establishment Inspection Report(EIR) for the Post Marketing Adverse Drug Experience Inspection conducted by the USFDA from June 25, 2018 to June 29, 2018, indicating closure of inspection. August 6, 2018 Pursuant to Regulation 30 of SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, please be informed that the Company’s API manufacturing facility at Roha, Maharashtra was inspected by US FDA from 30/7/2018 to 03/08/2018. Four observations were made which do not impact continuity of the Company’s business and its manufacturing activity. The Company proposes to respond to these observations within 15 business days. The Roha facility manufactures API for use in the production of formulations that are exported to the USA. August 1, 2018 Pursuant to Regulation 30 of SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, please be informed that the Company’s API manufacturing facility at Pithampur, Madhya Pradesh was inspected by US FDA from July 23rd to July 27th, 2018. Four observations were made which do not impact continuity of the Company’s business and its manufacturing activity. The Company proposes to respond to these observations within 15 business days. The Pithampur facility manufactures API for use in the production of formulations that are exported to the USA. May 7, 2018 Unichem Laboratories Limited is pleased to announce that it has received ANDA approval from United States Food and Drug Administration (USFDA) for Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg, which are therapeutically equivalent to DIOVAN® (Valsartan) tablets, 40 mg, 80 mg, 160 mg and 320 mg of Novartis Pharmaceuticals Corp. Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. September 20, 2017 Unichem Laboratories Limited is pleased to announce that it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg, and 300 mg/12.5 mg, which are therapeutically equivalent to Avalide Tablets 150 mg/12.5 mg, and 300 mg/ 12.5 mg of Sanofi-Aventis U.S. LLC. July 25, 2017 Unichem Laboratories Limited is pleased to announce that it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Losartan Potassium and Hydrochlorothiazide tablets USP, 50mg/12.5 mg, 100mg/12.5mg, and 100 mg/25mg, which are therapeutically equivalent to Hyzaar Tablets 50mg/12.5 mg, 100mg/12.5mg, and 100 mg/25mg of Merck Sharp & Dohme Corporation. June 7, 2017 Unichem Laboratories Limited is pleased to inform that the Company’s formulations manufacturing facility at Ghaziabad has received an Establishment Inspection Report (EIR) from the USFDA. This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). The inspection has now been closed by the USFDA. The inspection was carried out between 24th Feb 2017 to 3rd March 2017. April 17, 2017 The Company has received ANDA approval from the United States Food and Drug Administration (USFDA) for Piroxicam Capsules USP 10mg & 20mg, which are therapeutically equivalent to Feldene Capsules 10mg & 20mg of Pfizer, Inc. Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) indicated for relief of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA). For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once daily. If desired, the daily dose may be divided. Usually lowest effective dosage for the shortest duration, consistent with individual patient treatment goals is recommended. The product will be commercialized from Unichem’s Goa plant. Active Pharmaceutical Ingredient will also be made in house at Roha API Plant. March 20, 2017 The Company’s Formulation manufacturing facility at Goa was inspected by USFDA from March 14th 2017 to March 20th 2017. There were few observations made, and these in the opinion of the Company are correctable ones in respect to which the Company will file the necessary response within the stipulated period of 15 working days. The observations do not impact business continuity and the Company’s supplies to the US market. March 08, 2017 Unichem Laboratories Limited is pleased to announce that it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate ODT 5mg & 10mg and Rizatriptan Benzoate Tablets USP, 5mg & 10mg which are therapeutically equivalent to Maxalt – MLT Tablets 5mg & 10mg and Maxalt Tablets 5mg 10mg of Merck & Company, Inc. March 06, 2017 The Company’s formulation manufacturing facility at Ghaziabad was inspected by the USFDA from February 24, 2017 to March 3, 2017. The two observations cited are, in the opinion of the Company, correctable ones in respect of which the Company will file the necessary response within the stipulated period of 15 working days. The observations do not impact business continuity and the Company’s supplies to the US market. March 09, 2016 Unichem Laboratories receives Final ANDA approval from USFDA for Quetiapine Fumarate Tablets January 29, 2016 Unichem Laboratories receives Final ANDA approval from USFDA for Alfuzosin Hydrochloride Extended-Release Tablets USP December 8, 2015 Press Release – Unichem Laboratories receives Final ANDA approval from USFDA for Irbesartan Teblets USP October 16, 2015 Press Release – Unichem Laboratories receives ANDA approval from USFDA for Losartan Potassium Tablets USP October 14, 2015 Press Release – Unichem Laboratories receives Final ANDA approval from USFDA for Memantine Hydrochloride Tablets USP October 12, 2015 Press Release – Clarification on news article Company plans sale of its Domestic Formulations business October 09, 2015 Press Release – Unichem Laboratories receives ANDA approval from USFDA for Montelukast Sodium Tablets July 13, 2015 Invitation for conference call on Monday, 13th July, 2015 Unichem Laboratories Ltd Q1 & FY16 Results Conference Call January 23, 2014 Press Release – Unichem Laboratories receives ANDA approval from USFDA for METRONIDAZOLE TABLETS October 25, 2013 Press Release – Unichem Laboratories Investors Update on Sale of Indore SEZ Plant October 24, 2013 Press Release – Unichem Laboratories receives ANDA approval from USFDA for AMLODIPINE BESYLATE TABLETS November 29, 2012 Press Release – Unichem Laboratories receives ANDA approval from USFDA for TIZANIDINE TABLETS. October 26, 2012 Press Release – Unichem Laboratories receives ANDA tentative approval from USFDA for MEMANTINE HYDROCHLORIDE TABLETS. October 17, 2012 Press Release – Unichem Laboratories receives ANDA tentative approval from USFDA for IRBESARTAN TABLETS. October 07, 2011 Press Release – Unichem Laboratories receives ANDA approval from USFDA for LAMOTRIGINE TABLETS. April 07, 2011 Press Release – Unichem Laboratories receives ANDA approval from USFDA for ……… December 14, 2010 Press Release – Unichem Laboratories to secure their brands against… October 19, 2010 Press Release – Clarification on NPPA Price Fixation Order Dated October 11, 2010 September 23, 2010 Press Release – Unichem Laboratories receives CEP for Alfuzosin Hydrochloride………. August 03, 2010 Press Release – Unichem receives ANDA approval from USFDA for… March 03, 2010 Press Release – Unichem granted EU GMP certificate… February 19, 2010 Press Release – Unichem receives CEP for Meloxicam… February 19, 2010 Press Release – Unichem receives CEP for Zolpidem Tartrate… February 04, 2010 Press Release – Ghaziabad facility recertified by MHRA, U.K… January 20, 2010 Press Release – Unichem receives ANDA approval from USFDA for… December 04, 2009 Press Release – Niche Generics Ltd receives Marketing Authorizations for “Anastrozole” November 10, 2009 Press Release – Unichem received approval from US FDA for Pithampur API facility… August 27, 2009 Press Release – Unichem receives ANDA approval from USFDA for… August 19, 2009 Press Release – Unichem receives ANDA approval from USFDA for…
