News

‘Zyrifa’ is priced at MRP of Rs 12,495

Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Formycon AG

This inspection was conducted following the warning letter issued on August 29, 2024 by the USFDA

Empagliflozin and Linagliptin Tablets had annual sales of $215.8 million in the United States

Under this pact, RK Pharma will manufacture and supply the finished product, while the company will be responsible for the NDA submission and commercialization of the product in the US

Verapamil Hydrochloride Extended-Release Tablets will be produced at Zydus Lifesciences, Baddi, Himachal Pradesh

Leuprolide Acetate injection had annual sales of $69 million in the United States

Diroximel fumarate delayed-release capsules will be produced at Zydus Lifesciences, SEZ

Diroximel fumarate delayed-release capsules will be produced at Zydus Lifesciences, SEZ

Amplitude Surgical (Amplitude) is a wholly owned subsidiary of Zydus MedTech France SAS, a wholly owned subsidiary of the company

Venlafaxine ER Capsules will be produced at the company’s manufacturing facility at Moraiya, Ahmedabad

Olaparib tablets had annual sales of $1,379.4 million in the United States

The consolidated total income of the company increased by 17.47% at Rs 6,232.20 crore for Q2FY26

Desidustat is a HIF-PHI and has the potential to increase haemoglobin and red blood cell counts

The company has received the establishment inspection report for an inspection at the group’s manufacturing plant located SEZ - II, Ahmedabad

Budesonide capsules will be produced at is Zydus Pharmaceuticals

The EIR has classified the facility as Voluntary Action Indicated

Mesalamine suppositories are indicated for the treatment of mildly to moderately active ulcerative proctitis

In view of the same, Zydus MedTech France now holds 100% share capital and voting rights of the Target Entity

The company has initiated the Class II nationwide recall on September 24

Liothyronine tablets, a synthetic form of the thyroid hormone T3 (triiodothyronine), are primarily indicated for treating hypothyroidism

Deflazacort belongs to a group of medications called steroids

The EIR has classified the facility as VAI

Manufactured under stringent quality standards, ZyVet’s Furosemide tablets are available in multiple strengths to accommodate patient-specific dosing

Phenylpropanolamine hydrochloride is commonly prescribed to treat urinary incontinence in dogs due to urethral sphincter hypotonus

The inspection was conducted from August 25 to September 5, 2025 and concluded with 4 observations

Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Synthon BV of the Netherlands for Ozanimod Capsules for the United States market

Vaxiflu - Trivalent Influenza Vaccine is recommended for individuals aged 6 months and above

The company also planning to move forward with a regulatory submission to the U.S. Food and Drug Administration in the first quarter of 2026

The inspection concluded with NIL observations

The inspection was conducted from August 4, 2025 to August 13, 2025

The total consolidated income of the company increased by 7.30% at Rs 6728.60 crore for Q1FY26

Diltiazem Hydrochloride Tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm

This is the group’s first NOC approval in Canada

Zydus MedTech France now holds 85.6% of the share capital and voting rights of the Target Entity

The group now has 420 approvals and has so far filed around 484 ANDAs since the commencement of the filing process in FY 2003-04

At the closure, there were no observations noted, and the site was recommended for approval

The group now has 428 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04

The immediate objective of incorporation of Zylidac is to acquire the target assets of Agenus

The inspection is closed with 2 observations and none of them were related to data integrity

This facility underwent an inspection from March 10, 2025 to March 14, 2025

This facility underwent an inspection from April 21 to April 25 2025

The acquisition is expected to be completed within 60 days from the date of execution of the definitive agreement, with a potential 30- days extension

The group now has 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04

The Company has entered into SSSA to acquire up to 26.20% equity shares of Torrent Urja 26, for setting up captive hybrid power project in Gujarat.

Usnoflast is a novel oral NLRP3 inhibitor for the treatment of amyotrophic lateral sclerosis

The group now has 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04

The EIR report has classified it as No Action Indicated

Zydus’ generic Glatiramer Acetate Injection, developed in collaboration with Chemi S.p.A., will be manufactured entirely in Europe

Niacin-Extended-Release tablets will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad

The inspection concluded with 6 observations and none of them were related to Data Integrity

This agreement marks a significant step in Zydus MedTech’s strategic expansion into the fast-growing interventional cardiology segment

Feldan’s proprietary Shuttle peptide technology enables the efficient and targeted delivery of biomolecules into cells, unlocking new therapeutic possibilities

The drug firm is recalling the affected lot due to CGMP deviations

Zydus MedTech (France) SAS will be acquiring the equity shares of the Amplitude Surgical SA, France

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy in patients 5 years of age and older

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer

Eluxadoline tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad

The inspection concluded with NIL observations

Illexcor is developing a first-in-class oral drug that directly targets the root cause of SCD

Methenamine Hippurate tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad

Ketoconazole shampoo will be produced at the Group’s topical manufacturing site at Changodar, Ahmedabad

Dasatinib tablets had annual sales of $1807.7 million in the United States

With the launch of ANVIMO, the company has significantly reduced the cost by 91% of the innovator price

The project is expected to get underway in March 2025, and is being supported by the Gates Foundation

Zydus’s Quadrivalent Inactivated Influenza vaccine VaxiFlu-4 will offer seasonal protection against four new virus strains

Ibuprofen and Famotidine tablets had annual sales of $3.6 million in the United States

The partnership will provide impetus to company’s strategic focus on high unmet need therapy area

Zydus will be responsible for the NDA submission and commercialisation of the product in the US

Total consolidated income of the company increased by 17.25% at Rs 5326.6 crore for Q3FY25

Orphan drug designation by USFDA for Usnoflast, provides eligibility for certain development incentives

CVS Caremark will add the company’s Zituvio and combination products to its template formulary starting January 1, 2025

Lidocaine and Prilocaine cream will be produced at the Group’s topical manufacturing site at Changodar, Ahmedabad

ZyVac TCV is indigenously developed and manufactured at the Zydus Biotech Park, Ahmedabad

Fludrocortisone acetate tablets will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad

This facility underwent an inspection from July 15 to 19, 2024

Enzalutamide capsules, 40 mg had annual sales of $869.4 million in the United States

Any drug candidate emerging from the efforts will be developed by Zydus for India and other markets

The Target Business of SBL consists of a portfolio of fermentation-based API products like Lovastatin, Daunorubicin, Doxorubicin and Epirubicin

Viwit will be responsible for ANDA submission, manufacturing and supplying the generic versions of GADAVIST and DOTAREM

The inspection closed with 4 observations

Letermovir tablets are used to prevent disease caused by a virus called cytomegalovirus in people who have received a bone marrow transplant or kidney transplant

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara

The drug will target specific genetic mutations prevalent in certain types of cancers, paving the way for more tailored and effective treatment approach

This facility underwent an inspection from December 14 to 22, 2023 and has been classified as Voluntary Action Indicated

This confirms that the inspected facility has been considered as ready to commercially manufacture and supply the Enzalutamide API

With this, Miltefosine will be added to WHO’s pre-qualification list which will enable larger access to the drug globally

The company has incorporated WOS on February 20, 2024

Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg had annual sales of $47 million in the United States

Total consolidated income of the company increased by 5.76% at Rs 4542.90 crore for Q3FY24

The product will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh

The company has also received final approval to market Dexamethasone Tablets USP, 2 mg

The drug will be manufactured at the group’s manufacturing premises

The product will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets, and thereafter, for the manufacturing and supply of the product

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis.

ZYIL1 is a novel oral small molecule NLRP3 inhibitor. Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation

The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India)

The company has also received tentative approval for Darunavir Tablets 75 mg and 150 mg

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India

The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome

Methylene Blue Injection, 10mg/2ml and 50mg/5ml had an annual sale of around $73.4 million in the United States (IQVIA MAT October-2023)

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India

Torrent will pay Zydus upfront licensing fees and milestone payments based on the achievement of pre-defined milestones

Total consolidated income of the company increased by 9.21% at Rs 4,422.80 crore for Q2FY24

ZITUVIMET is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products

Lupin will have semi-exclusive rights to co-market the product in India under the brand name LINVAS

The agreement aims to jointly promote the Guardant360 portfolio of liquid and tissue biopsy tests across India and Nepal

The group’s subsidiary LM Manufacturing has an oral liquids manufacturing site at Weedon, Northampton, UK, which supplies products to the US and UK markets

Desidustat is first-of-its-kind oral treatment for anemia associated with Chronic Kidney Disease in India

ALS results in loss of motor neurons in the brain and spinal cord which controls voluntary muscle movement

The approval of ZITUVIO is based on research, development, regulatory and manufacturing work performed by Zydus teams

The injection will be manufactured at the group’s injectable manufacturing facility at Jarod

The drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India)

This was a Pre-Approval Inspection and had concluded with NIL observations

The company has completed the acquisition of 65,06,500 equity shares

The transdermal patch will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad

The inspection was a cGMP Inspection and had ended with NIL observations

The company has incorporated WOS on September 6, 2023 in Canada

The drug will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility at Jarod

Doxepin Tablets, 3 mg and 6 mg had annual sales of $43.4 million in the United States

Total income of the company increased by 57.48% at Rs 3,038.10 crore for Q1FY24

The company has been granted a CGT designation by the USFDA for its Indomethacin suppositories

An agreement to amend certain clauses of the JVA to enable participation in tenders of some government institutions / public sector undertakings

The drug will be manufactured at the group’s injectable manufacturing facility of Zydus Lifesciences (Alidac) at SEZ, Ahmedabad

The Pre-Approval Inspection closed with nil observations

The group now has 374 approvals and has so far filed over 442 ANDAs as of March 31, 2023 since the commencement of the filing process in FY 2003-04.

The inspection has been classified as Voluntary Action Indicated

Palbociclib Tablets, 75 mg, 100 mg, and 125 mg had annual sales of $3.3 billion in the United States

The proposed investment in Mylab will help the company to participate in growing diagnostics space

The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

The cGMP inspection concluded with NIL observations

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ

Balsalazide Disodium is used to treat bowel diseases like ulcerative colitis

The Phase IV EVIDENCES- XI trial will enroll around 1500 male and female NAFLD patients with comorbidities

The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

The inspection closed with nil observations

Total consolidated income of the company increased by 29.96% at Rs 5048.40 crore for Q4FY23

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod

The Audit had ended with NIL observations

Sucralfate Tablets USP, 1 gram had annual sales of $84 million in the United States

Metronidazole Topical Cream, 0.75% had annual sales of $25 million in the United States

Icosapent Ethyl Capsules, 0.5 g and 1 g had annual sales of $1,316 million in the United States

The drug will be manufactured at the group’s formulation manufacturing facility in Baddi, Himachal Pradesh

The drug will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara

The drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India)

The product will be manufactured at the group’s formulation manufacturing facility in SEZ Ahmedabad

The product will be manufactured at the group’s formulation manufacturing facility in Baddi, Himachal Pradesh

The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod

The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences

The inspection was a Pre-Approval Inspection as well as a GMP Audit and concluded with three observations

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad

ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates

The products will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India)

Erythromycin Tablets USP, 250 mg and 500 mg had annual sales of $25.1 million in the United States

Lenalidomide may lessen the need for blood transfusions

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya

The drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India)

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of $49.4 million in the United States

Gabapentin tablets are indicated for the management of Postherpetic Neuralgia

Sirolimus Tablets had annual sales of $69mn in the United States

The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad

Canagliflozin Tablets had annual sales of $660 million in the United States

Total consolidated income of the company increased by 18.92% to Rs 4400.80 crore for the quarter under review

The inspection concluded with NIL observations

The group now has 340 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04

The group now has 340 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules in the United States

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India

The group now has 338 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad

Topiramate Extended-Release capsule is indicated to prevent and control seizures in people with epilepsy

Levothyroxine Sodium injection is indicated for the treatment of myxedema coma

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India

CanAssist Breast is a test to optimize treatment selection in early stage (I & II) hormone receptor positive, HER2 receptor negative type of breast cancer

Total consolidated income of the company increased by 9.60% to Rs 4,179.10 crore for Q2FY23

Bisoprolol Fumarate and hydrochlorothiazide combination is indicated to treat high blood pressure

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated

The company will acquire up to 12.17% stake, in one or more tranches, on fully diluted basis in AMP throughout the term of the definitive agreements

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India

Ketorolac Tromethamine Tablets had annual sales of $ 17mn in the United States

The company is eligible for 180 days of shared generic drug exclusivity for Brivaracetam Tablets USP 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India

Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of $2.42 billion in the United States

Sildenafil for oral suspension is used to treat high blood pressure in the lungs

null of these observations were related to data integrity

Lenalidomide is used to treat various types of cancers

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India

Cariprazine Capsules had annual sales of $2.39 billion in the United States according to IQVIA MAT July 2022

MonoFerric is available in over 30 countries including US and Europe and over 28 million doses have been administered since launch

ZYIL1 was safe and well-tolerated and there were no Serious Adverse Events (SAE’s) observed in this Phase 2 trial

The company’s US-based unit is recalling the affected lot due to Failed Impurities/Degradation Specifications

Venlafaxine is used to treat depression, anxiety, panic attacks and social anxiety disorder

The Phase IV DREAM-CKD trial will enrol 1004 CKD patients in India, including 502 dialysis dependent, 502 dialysis independent CKD patients with anemia

The group now has 320 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04

The inspection concluded with four Form 483 observations

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India

The drug will be manufactured at the group’s topical manufacturing facility at Ahmedabad, India

The drug will be manufactured at the group’s topical injectable manufacturing facility at Jarod, India

Efinaconazole is an azole antifungal used for the topical treatment of Onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes

The drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India

The drug provides best in class achievement of Hemoglobin A1C goals with proven safety profile

The company’s board has approved the proposal to buyback a little over 1.15 crore shares, representing up to 1.13 per cent of the total paid-up equity share capital of the company

A combination of Adapalene (a retinoid) and Benzoyl Peroxide (an antibiotic and skin-peeling agent), the gel is used to decrease the number and severity of acne pimples

The drug will be manufactured at group’s drug formulation facility at SEZ, Ahmedabad