INDIA’S FIRST NEW DISCOVERY ANTIBIOTICS FROM WOCKHARDT GRANTED INDIAN REGULATORY APPROVAL

India’s First New Discovery Antibiotics from Wockhardt Granted Indian Regulatory Approval Wockhardt: 1st Indian Company to Achieve Approval for New Discovered Antibiotics Indian drug regulator, DCGI has approved Wockhardt’s 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centres across India. The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR). The size of Indian Antibiotic market is approx. 16,000 Crore, growing at 7% and is one of the largest therapeutic segment, with a 12% market share of the Indian Pharmaceutical Market1. “By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over the currently available anti -MRSA agents and its unique properties, I believe EMROK/EMROK -O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality”- said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group. Antimicrobial Resistance: A Medical Challenge (38% Resistance in India) AMR is a major public health problem globally. India carries one of the largest burdens of drug ‑ resistant pathogens worldwide. Inf ections caused by drug -resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health -care systems, and hinder the goals of sustainable development. Two milli on deaths are projected to occur in India due to AMR by the year 20502. World Health Organisation (WHO) in 2017 has listed Methicillin resistant S. aureus (MRSA) as a ‘high’ priority pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings3. In 2018, a national study conducted by the Indian council of Medical research (ICMR) and Anti -microbial resistant surveillance network (AMRSN) group highlighted the high prevalence of 38.6% of MRSA in India 4. A recent Indian study reports that 1 in 6 patients infected with multidrug resistant Gram positive infections die in intensive care units5. Limitations of Current Treatments Currently available anti -MRSA agents have multiple side effects such as kidney damage, dec rease in platelet cell counts, muscle pain, to name a few 6; which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. The patient management is further complicated due to increasing resistance to these agents and drying antimicrobial pipeline. EMROK / EMROK O: The Modern Gram positive Antibiotic against Methicillin Resistant Staphylococcus aureus Infections  EMROK and EMROK-O are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across globe. While the non-clinical and Phase 1 studies have been undertaken in U.S. Europe and India, the Phase 2 and Phase 3 clinical studies have been successfully completed in India.  More than 50 international publications/posters in top -notch journals/ scientific conferences and studies by leading international experts have established that EMROK/EMROK -O repre sents a truly multi-spectrum MRSA drug with potent bactericidal action against Gram positive, quinolone susceptible Gram negative, anaerobic and atypical bacteria.  Clinical and non-clinical studies have established advantageous safety features of EMROK/EMROK-O compared to older MRSA drugs vancomycin, teicoplanin, daptomycin and linezolid which are beset with unfavourable features of nephrotoxicity, bone -marrow toxicity and muscle toxicity therefore cannot be given in patients with impaired kidney/liver f unction and seriously ill patients requiring for longer duration therapy  After a significant gap of 14 years, a new anti -MRSA agent will be made available by Wockhardt as ‘EMROK’ for the management of resistant superbug. Wockhardt’s research commitment to global antibiotic discovery Due to the combination of complexity of resistance mechanisms expressed by bacteria as well as lack of financial resources to fund antibiotic research, many major pharmaceutical firms have steered away from the antibiotic research in the last 30 years. In such challenging scenarios, Wockhardt Ltd. has invested for more than two decades in developing a strong antibiotic pipeline catering both multi drug resistant Gram positive and Gram negative pathogens and is the only com pany in the world having five antibiotics against superbugs in the late phase of clinical development. All these antibiotics, because of their promising activity against MDR pathogens, have received US FDA -QIDP status for expediting the drug development c ycle. Out of the five, the first two antibiotics - EMROK and EMROK-O have been approved by DCGI recently and will be launched soon. Bibliography: 1. IQVIA data 2. Dixit A, Kumar N, Kumar S, Trigun V. Antimicrobial resistance: Progress in the decade since emergence of New Delhi metallo-β-lactamase in India. Indian J Community Med 2019; 44:4-8. 3. Evelina T et.al. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis 2018 Mar; 18(3):318-327 4. Annual report AMR surveillance network Indian Council of Medical Research. January 2018 – December 2018. Accessed at https://www.icmr.nic.in/content/annual-report-antimicrobial- resistance-surveillance-network-jan-2018-dec-2018 5. Gandra et al. The mort ality burden of multidrug -resistant pathogens in India: a retrospective observational study. Clin Infect Dis. 2019 Aug 15; 69(4): 563–570. 6. Hien M. Nguyen. Limitations of antibiotic options for invasive infections caused by methicillin - resistant Staphylococcus aureus: is combination therapy the answer? J Antimicrob Chemother 2010; 65: 24–36 EMROK/EMROK O: List of International publication/Posters International Publications 1. Levonadifloxacin (WCK 771) exerts potent intracellular activity against Staphylococcus aureus in THP -1 monocytes at clinically relevant concentrations. Jacques Dubois, Maïtée Dubois. Journal of Medical Microbiology, Nov 5 2019. DOI: 10.1099/jmm.0.001102. [Ahead of print] 2. In Vitro Activity of Levonadifloxacin (WCK 771) against Chlamydia pneumoniae. Stephan Kohlhoff et al. Antimicrobial Agents and Chemotherapy, 63(8), e01048-19, 2019. DOI: 10.1128/AAC.01048-19. 3. In vitro bactericidal activity of levonadifloxacin (WCK 771) a gainst methicillin - and quinolone -resistant Staphylococcus aureus biofilms. Melroy Tellis et al., Journal of Medical Microbiology, Accepted Manuscript Posted Online 26 June 2019. DOI 10.1099/jmm.0.000999. 4. In vivo pharmacokinetic/pharmacodynamic targets o f levonadifloxacin against Staphylococcus aureus in a neutropenic murine lung infection model. Bhagwat S.S et al., Antimicrobial Agents and Chemotherapy, 63(8), e00909 -19, 2019. DOI:10.1128/AAC.00909-19. 5. Identification of metabolites of novel Anti-MRSA fluoroquinolone WCK 771 in mice, rat, rabbit, dog, monkey and human urine using liquid chromatography tandem mass spectrometry. Yeole R.D., et al., Biomedical Chromatography, 33(7), e4532, 2019. DOI: 10.1002/bmc.4532 6. Electrocardiographic Effects of a Supr atherapeutic Dose of WCK 2349, a benzoquinolizine fluoroquinolone, Jay W. Mason, Clinical and Translation Science. 12, 47-52, 2018. DOI: 10.1111cts.12594 7. In Vitro Activities of the Benzoquinolizine Fluoroquinolone Levonadifloxacin (WCK 771) and Other Antimicrobial Agents against Mycoplasmas and Ureaplasmas in Humans, Including Isolates with Defined Resistance Mechanisms , G. Xue, et al., Antimicrobial Agents and Chemotherapy, 62(11), e01348-18. DOI: 10.1128/AAC.01348-18 8. Intrapulmonary Pharmacokinetics of Levonadifloxacin following Oral Administration of Alalevonadifloxacin to Healthy Adult Subjects. Keith A. Rodvold et al., Antimicrobial Agents and Chemotherapy, 62(3), 2018, e02297-17. DOI:10.1128/AAC.02297- 17 9. In Vitro Activity of the Quinolone WCK 771 against Recent U.S. Hospital and Community -Acquired Staphylococcus aureus Pathogens with Various Resistance Types. Bhagwat S.S et al., Antimicrobial Agents and Chemotherapy, 2009, 53(2): 811-813. DOI: 10.1128/AAC.01150-08 10. Simple liquid chromatography –tandem mass spectrometry method for determination of novel anti -methicillin-resistant Staphylococcus aureus fluoroquinolone WCK 771 in human serum. Yeole R.D. et al., Journal of Chromatography B, 2007, 846(1-2): 306-312. DOI: 10.1016/j.jchromb.2006.09.022 11. The Anti-Methicillin-Resistant Staphylococcus aureus Quinolone WCK 771 Has Potent Activity against Sequentially Selected Mutants Has a Narrow Mutant Selection Window against Quinolone -Resistant Staphylococcus aureus, and Preferentially Targets DNA gyrase. Bhagwat S.S, et al ., Antimicrobial Agents and Chemotherapy , 2006, 50(1): 3568 -3579. DOI: 10.1128/AAC.00641-06 12. Validated chiral high -performance liquid chromatography method for a novel anti -methicillin-resistant staphylococcus aureus fluoroquinolone WCK 771. Yeole, R.D. et al., Journal of Chromatography A, 2006, 1108(1): 38 -42. DOI: 10.1016/j.chroma.2005.12.085 13. Nadifloxacin: a quinolone for topical treatment of skin infections and potential for systemic use of its active isomer, WCK 771.Michael R Jacobs. et al., Expert Opinion on Pharmacotherapy 2006, October 4:7(14): 1957 -1966. DOI: 10.1517/14656566.7.14.1957 14. Activity of the new quinolones WCK 771, WCK 1152 and WCK 1153 against clinical isolates of Streptococcus pneumoniae and Streptococcus pyogenes Adnan Al-Lahham et al., Journal of Antimicrobial Chemotherapy, 2005, 56(6):1130 - 1133. DOI: 10.1093/jac/dki361 15. Recently approved and investigational antibiotics for treatment of severe infections caused by Gram -positive bacteria. Peter C Appelbaum et al., Current Opinion in Microbiology 2005, 8(5): 510-517. DOI: 10.1016/j.mib.2005.07.001 16. Activity of the new quinol one WCK 771 against pneumococci. Peter C Appelbaum et al., Clinical Microbiology and Infection 2005, 11: 9-14. DOI: 10.1111/j.1469-0691.2004.01017.x 17. A Chiral Benzoquinolizine -2-carboxylic Acid Arginine Salt Active against Vancomycin -Resistant Staphylococcus aureus. Noel J. de Souza et al., Journal of Medicinal Chemistry., 2005, 48(16): 5232-5242. DOI: 10.1021/jm050035f 18. Antistaphylococcal Activity of WCK 771, a Tricyclic Fluoroquinolone, in Animal Infection Models. Patel M.V. et al., Antimicrobial Agents and Chemotherapy, Dec. 2004: 48(12), 4754-4761. DOI: 10.1128/AAC.48.12.4754-4761.2004 19. In Vitro Activity of the New Quinolone WCK 771against Staphylococci, Michael R. Jacobs et al., Antimicrobial Agents and Chemotherapy, 2004: 48(9), 3338-3342. DOI: 10.1128/AAC.48.9.3338-3342.2004 20. Antianaerobic Activity of a Novel Fluoroquinolone, WCK 771, Compared to Those of Nine Other Agents, Mihaela Peric et al., Antimicrobial Agents and Chemotherapy, Aug. 2004, 48(8): 3188-3192. DOI: 10.1128/AAC.48.8.3188-3192.2004 21. Antibacterial susceptibility of a vancomycin -resistant Staphylococcus aureus strain isolated at the Hershey Medical Center. Bulent Bozdogan et al., Journal of Antimi crobial Chemotherapy 2003, November 1: 52(5): 864 -868. DOI: 10.1093/jac/dkg457 International Posters 22. F-0558- Patel MV, et al., (39 th ICAAC 1999, San Francisco), S -(-)-Nadifloxacin: Oral Biovailability and Bioefficacy in Mouse Model of Staphylococcal Septicemia. 23. Jacob MR, et al., (41st ICAAC 2001, Chicago), Activities of WCK 771A and WCK 919, Two Experimental Quinolones, Compared with Five Other Quinolones against Quinolone Susceptible and Resistant Staphylococci. 24. Pankuch GA, et al., (41st ICAAC 2001, Chicago), Antipneumococcal Activities of WCK 771A and WCK 919 (Two New Quinolones) Compared to 12 Other Agents against 177 Quinolone-Susceptible Pneumococci. 25. (F-534) Upadhyay DJ, et al., (41st ICAAC 2001, Chicago), WCK 771 A – An Investigational Anti-MRSA Fluoroquinolone (FQ) wit Potent Concentration Independent Cidal Action and An Unusual Ability to Kill Slow Growing Staphylococci. 26. (F-535) Gupte SV, et al., (41st ICAAC 2001, Chicago), In Vitro and In Vivo Efficacy of an Investigational Fluoroquinolone (FQ) WCK 771 against Pneumococci. 27. (F-536) Patel MV, et al., (41st ICAAC 2001, Chicago), WCK 771 A – An Investigational Anti -staphylococcal Fluoroquinolone (FQ) with Strong Bactericidal Activity against Low and High Density Cultures. 28. (F-537) Gupte SV, et al., (41st ICAAC 2001, Chicago), The Impact of NorA Mediated Efflux on In Vitro and In Vivo Anti- Staphylococcal Efficacy of an Investigational Fluoroquinolone (FQ) WCK 771 A and Other FQs. 29. (F-538) Upadhyay DJ, et al., (41st ICAAC 2001, Chicago), WCK 771 A – An Investigational Fluoroquinolone (FQ) with Unusual Property of Retaining Potency in Acidic Medium, Human Urine and Efficacy in Mouse Pyelonephritis Model. 30. (F-539) Patel MV, et al., (41st ICAAC 2001, Chicago), Efficacy of WCK 771 A in Systemic Infections Caused by MSSA and MRSA, Pharmacodynamic (PD) Parameters at Efficacy Dose and MRSA Eradication from Mouse Vital Organs. 31. (F-540) Patel MV, et al., (41st ICAAC 2001, Chicago), In Vivo Efficacy of Fluoroquinolone (FQ) WCK 771 A in Thigh Infections Caused by MSSA and MRSA. 32. Appelbaum PC, et al., (42nd ICAAC 2002, San Diego), Anti-Anaerobic Activity of Two New Quinolones, WCK 771A And WCK 919, Compared to Nine Other Agents. 33. (F-563) Upadhyay DJ, et al., (42nd ICAAC 2002, San Diego), WCK 771- Pharmacodynamic (PD) Parameters for MRSA and VISA (Vancomycin Intermediate S. aureus) Eradication in In Vitro Pharmacokinetic Model (IVPM) 34. (F-564) Gupte SV, et al., (42nd ICAAC 2002, San Diego), WCK 771 - Eradication Efficacy for Methicillin Sensitive (MSSA) and Resistant Staphylococcus aureus (MRSA) Skin Abscess. 35. (F-438) Bozdogan, B, et al., (43 rd ICAAC 2003, Chicago), Bactericidal activities of new quinolones WCK 771 A, WCK 919, and its two isomers WCK 1152 and WCK 1153 against vancomycin resistant Staphylococcus aureus (VRSA). 36. (A-1165) Patel MV, et al., (43rd ICAAC 2003, Chicago), WCK 771 - Predictive MRSA Eradication Through In Vitro Pharmacokinetic Model (IVPM) Based on Human PK. 37. (F-430) Deshpande PK, et al., (43rd ICAAC 2003, Chicago), WCK 771- A Chiral Benzoquinolizine-2-carboxylic acid arginine salt active against vancomycin intermediate staphylococcus aureus (VISA). 38. (F-431) Patel MV, et al., (43rd ICAAC 2003, Chicago), WCK 771- An investigational FQ with high intravenous tolerability. 39. (C1-63) De Souza NJ, et al., (43rd ICAAC 2003, Chicago), Fluoroquinolones (FQs) WCK 1152, WCK 771 and Derivatives thereof Inhibit Multidrug Efflux Pumps (EP) of P. aeruginosa (PA), E. coli (EC), S. pneumoniae (SPN) and S. aereus (SA). 40. (A-21) Maharaj N, et al., (44th ICAAC 2004, Washington), A Phase 1 Study of Escalating Single Doses of Intravenous (IV) WCK 771. 41. (A-440) Gupte SV, et al., (45th ICAAC 2005, Washington), WCK 771: Gram -negatives Breakpoint Determination through IVPM (In vitro Pharmacokinetic Model) Study Based on Human Pharmacokinetic Parameters. 42. (A-11) Jha R, et al., (45th ICAAC 2005, Washington), WCK 771 - Intravenous Multiple Dose Phase- I Study. 43. (A-1829) Bhagwat SS, et al., (45th ICAAC 2005, Washington), WCK 771 Proposed PK -PD Breakpoint Would Provide Coverage of QRSA (Quinolone Resistant Staphylococcus aureus ) with Multiple QRDR (Quinolone Resistance Determining Regions) Mutations. 44. (C1-1409) Bhagwat SS, et al., (45th ICAAC 2005, Washington), WCK 771 Selects First Step Mutants of S. aureus in DNA Gyrase. 45. (A-1093) Jha R , et al., ( 46th ICAAC 2006, San Francisco ), WCK 771: A Phase I Study of Safety, Tolerability and Pharmacokinetics of 800 mg Multiple Dose Intravenous Infusion. 46. (F1-2129), McGhee P, et al., (47th ICAAC 2007, Chicago), Comparative Activity of WCK 771 Against S. aureus With Raised Vancomycin and Daptomycin MICs and Other Resistotypes. 47. (F1-2133a), Shetty NM, (47 th ICAAC 2007, Chicago), WCK 2349 - A novel fluoroquinolone (FQ) Prodrug -13 Week Oral (PO) safety profile in cynomolgus (Cy.) Monkeys. 48. (F1194) Hackel, M. (55th ICAAC 2015, San Diego), Determination of tier 1 quality control ranges for WCK 771. 49. (F1195) Hackel, M. et al., (55 th ICAAC 2015, San Diego ), Determination of disk diffusion zone and broth dilution MIC correlations, and broth dilution agar dilution MICs for WCK 771 50. (F1196) Hackel, M. et al., (55 th ICAAC 2015, San Diego), In Vitro Activity of WCK 771, a New Benzoquinolizine Quinolone In Development, Against Key Bacterial Groups from the USA and Europe. 51. (Sunday 456) Flamm, R.K. et al., (ASM Microbe 2016, Boston), In Vitro Activity of WCK 771, a Benzoquinolizine Fluoroquinolone (Levonadifloxacin) when Tested A gainst Contemporary Gram-Positive and -Negative Bacteria from a Global Surveillance Program. 52. (P1270) Preston R, et al., (ECCMID 2016, Amsterdam), Single-Center, phase 1, open label, single dose study to evaluate the pharmacokinetics and safety of WCK 2349 in patients with hepatic impairment. 53. (P1269) Mason JW, et al., (ECCMID 2016, Amsterdam), Electrocardiographic effects of WCK 2349. 54. (P1270) Preston R, et al., (ECCMID 2016, Amsterdam), Single-center, phase 1, open label, single dose study to evaluate the pharmacokinetics and safety of WCK 2349 in patients with hepatic impairment. 55. (P1268) Chugh R, et al., (ECCMID 2016, Amsterdam), Safety and pharmacokinetics of multiple ascending doses of WCK 771 and WCK 2349. 56. (1267) Chugh R, et al., (ECCMID 2016, Amsterdam), Plasma and intrapulmonary pharmacokinetics of levonadifloxacin in healthy adults. 57. (P0620) Dubois J. et al., (ECCMID 2018, Madrid), In Vitro Activity of Levonadifloxacin (WCK 771) Against L. pneumophila. 58. (A-031) Melhrotra S. Pharmacokinetics of Intravenous Levonadifloxacin Administered as WCK 771 in Healthy US Adults. ANTIMICROBIAL RESISTANCE (AMR) Rising concern globally as well as in India BURDEN OF MRSA IN INDIA Prevalence of resistance Mortality rate Burden on community Burden on health care settings WOCKHARDT LIMITED • Global Headquarters: Wockhardt Towers, Bandra Kurla Complex, Mumbai-400051, India. • T: +91 22 26534444, F: +91 22 26523905 Regd. Office: D4, M.I.D.C., Chikalthana, Aurangabad-431006, India. • T: +91 240 6694444, F: +91 240 2489219 www.wockhardt.com • CIN: L24230MH1999PLC120720 listed MRSA as a ‘high’ priority pathogen due to 2009 2018 29% 38.6% 29% in 2017 38.6% Prevalence ICU Mortality GDP India Mortality 7 Lakh (current) Mortality: 2 million (by 2050) World’s GDP 0.5% (current) 10 million (by 2050) World’s GDP 2-3.5% (by 2050) 16%16% Gram positive infections including MRSA st ANTI-MRSA AGENTS IN INDIA st 20192005200320001986Year of Approval Country of Origin Antibiotics Teicoplanin EMROKLinezolid Daptomycin 1958 Vancomycin Tigecycline Nephrotoxicity, Ototoxicity, Redman syndrome Nephrotoxicity, Ototoxicity, MIC creep Marrow suppression, Thrombocytopenia, Lactic acidosis Linezolid Not effective for pneumonia, skeletal muscle toxicity Black box warning from the USFDA for all-cause mortality, GI side effects Vancomycin Tigecycline LIMITATIONS LIMITATIONS OF CURRENTLY AVAILABLE ANTI-MRSA AGENTS Daptomycin Teicoplanin WOCKHARDT LIMITED • Global Headquarters: Wockhardt Towers, Bandra Kurla Complex, Mumbai-400051, India. • T: +91 22 26534444, F: +91 22 26523905 Regd. Office: D4, M.I.D.C., Chikalthana, Aurangabad-431006, India. • T: +91 240 6694444, F: +91 240 2489219 www.wockhardt.com • CIN: L24230MH1999PLC120720 Unique structure Rapid bactericidal action Suitable for Long term use Better tissue penetration Unique mechanism of action: Dual action on DNA gyrase & topo IV No dose adjustments in hepatic and renal impairment Unique Broad spectrum of coverage: Gram-positive including MRSA, Respiratory Gram negative, atypical and anaerobic bacteria Superior safety: QT prolongation Liver enzyme elevation Phototoxic potential Easier to switch from IV to oral Eradicates biofilm EMROK Unique Features 01 03 05 06 04 07 08 02 09 10 UNIQUE FEATURES OF EMROK st NO} WOCKHARDT LIMITED • Global Headquarters: Wockhardt Towers, Bandra Kurla Complex, Mumbai-400051, India. • T: +91 22 26534444, F: +91 22 26523905 Regd. Office: D4, M.I.D.C., Chikalthana, Aurangabad-431006, India. • T: +91 240 6694444, F: +91 240 2489219 www.wockhardt.com • CIN: L24230MH1999PLC120720 References: 1. Review on Antimicrobial Resistance, Jim O’Neil Report 2016. 2 .Indian J Community Med 2019; 44:4-8. 3. ICMR annual report on AMR 2018. 4. Clin Infect Dis. 2019 Aug 15; 69(4): 563–570. 5. Lancet Infect Dis 2018 Mar; 18(3):318-327. WOCKHARDT LIMITED • Global Headquarters: Wockhardt Towers, Bandra Kurla Complex, Mumbai-400051, India. • T: +91 22 26534444, F: +91 22 26523905 Regd. Office: D4, M.I.D.C., Chikalthana, Aurangabad-431006, India. • T: +91 240 6694444, F: +91 240 2489219 www.wockhardt.com • CIN: L24230MH1999PLC120720 WOCKHARDT’S RESEARCH COMMITMENT TO GLOBAL ANTIBIOTIC DISCOVERY st 18 Superdrugs in advanced clinical development with 12 companiesGlobally 5 Superdrugs in advanced clinical development FY 2009 FY 2010 FY 2011 Patent Filings Cumulative (Nos) Patent Granted Cumulative (Nos) FY 2012 FY 2013 FY 2014 243 FY 2015 319 FY 2016 463 FY 2017 FY 2018 50 61 90 103 677 785 till date 45 10 12 14 44 61 91 138 194 252 26 Wockhardt has the Highest Patent filed in Antibiotic NCE ATM/AVI Clinical Suspended Wockhardt Pfizer Merck NacuGen GSK Shionogi Boston Pharma Allecra Entasis VenatoRx Spero Others Tibipenem/Pivoxil SPR206 ETX 2514/IMI ETX0282/ETX1317 MK 7655 Approved S-649266 NDA RG 6080 LYS228/IID572 AAI 101 VNRX 5133 Gepotidacin 5 1 1 1 1 1 1 1 2 1 2 1 Highest QIDP status granted (5 NCEs) by US FDA to Wockhardt than any other company India’s first discovered novel chemical entity antibiotic and

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