Acme Group
2014 2015 New OSD WHO Geneva Pre Qualification/ Facility added INVIMA approval received 2012 New Sterile FDF Facility added 2010 In-house R&D Centre started 2008 Hormonal Production Facility added 2005 First OSD Facility Commences Operations 2016 2017 EU-GMP/ UKMHRA/ ANVISA / TGA Australia PICS approval received. Approval New R&D Centre at Bangalore commences operations 2018 Q1 filling USA Evolution Acme is a leading provider of Contract Manufacturing and Development services to the pharmaceutical industry for Oral and Sterile dosage form. Acme began its journey in 2005 and in a decade has transformed into a trusted partner and a complete solution provider. The Group has expanded into niche segments of Oral Hormones, both Sex Hormones and Levothyroxine, along with General Injectables - s and, catering through three state-of-the-art manufacturing facilities. Today it employs more than 2000 highlyskilled workforce at its facilities which are located in Northern India. The facilities are spread over an area of approx 500,000 sq ft having an annual capacity of 15 Billion s, 3 Billion Capsules and 42 Million /. In our journey over the past decade we have been audited and approved by various international regulatory agencies including UK-MHRA, EU-GMP, ANVISA, PICS, INVIMA, WHO-Geneva. Apart from this the Group has approvals across major countries in Asia, Africa, CIS and Latin Countries. US FDA filing is planned for Q2, 2018 as we continue our journey towards building a sustainable future. At Acme we offer Quality, Speed and Value by combining our technical competencies and cost effective solutions. Across our sites our development teams are proficient in Analytical Development: Method development and Validation Pre-Formulation Studies: Chemical / physical characterization and Drug / Excipient compatibility Formulation Development Stability Studies: Stability testing, Container closure compatibility, Storage at all Major ICH conditions Manufacturing and Supply With an invesment in excess of USD 150 million, Acme proudly serves more than 25 customers including many of the world s leading companies. With an unwavering focus on Service and Quality, Acme is strategically positioned to serve as a preferred business partner.
ORAL SOLID DOSAGE FACILITY General (s/capsules) Levothyroxine s EU-GMP Approved STERILE FDF FACILITY General Injections ( & ) () UK MHRA/ ANVISA/PICS Approved 2000 Highly Skilled Staff 500,000 sq. ft. area across 3 Facilities Multi Dosage & Complex Pharmaceutical Products Dedicated Facilities Exclusively focused on CMO as well as Risk Reward Partnership Models Oral Dosage (s & Capsules) in General Category Dedicated Female Sex/ Levothyroxine Hormone/s Suite & Injections Serving Top 25 Indian Pharmaceutical Companies & 5 Global MNCs Exporting to 40+ Countries in 3 continents Contract Development Orals, s, Topicals, Opthalmics, Parenterals, Oncology Capacity 15 Billion s, 3 Billion Capsules, 30 million ampoules, 12 million lyophilized vials International Accreditations WHO GENEVA / PICS/ INVIMA / UK MHRA/ ANVISA/US FDA* R&D CENTER Complex/Innovative Generic Drug Development Capabilities Oncology / High Potency/Opthalmics/ Oral s/ Oral s/ Dermatology Eminence ORAL SOLID DOSAGE FACILITY General (s/capsules) Female Sex Hormones (s) WHO Geneva pre-qualified
ACME FORMULATION Genesis Dosage Facility (GENERAL AND HORMONAL CATEGORY) Available Dosage Approvals Capacity Facility area s & Capsules WHO-Geneva, Tanzania, Nigeria, Ethiopia Ghana, Kenya, Yemen, Zimbabwe, Vietnam, Philippines, Zambia, Mozambique, Niger, Senegal, Sierra leone. 3.5 Billion s & 0.5 Billion capsules per annum 75000 sq. ft.
IMMACULE LIFESCIENCES Rising New Sterile Facility ( Injections & ) Available Dosage Approval Injections ( and ) & UK-MHRA, ANVISA, INVIMA, PICS, TGA Australia* & US FDA* Capacity 30 Million / & 12 Million Facility area 1,00,000 Sq. ft. * Filing scheduled in Q1 2018
VERITAS RESEARCH Veritas Research is a leading Research and Development Company with a team of over 30 professionals. With sound processes and systems in place including: QMS with well defined SOP's/ Plan/ Policy & Quality Manual, Validated metric management & IQA, Compliance to GCP, GLP, ISO standards & CFR Part 11 requirements, we are well entrenched to take your product from the idea to the commercializa on stage. Generic Drug Development (US, EU, Lat-AM and others) Orals - IR, MR s / Capsules orals - Solutions, Suspensions, Dry Syrups Topicals - Ointments/ Creams / Gels Ophthalmics Suspension / Ointments / Solutions Parenterals - Injections,, PFS, Innovative Generics [505 (B) (2)] Fixed dose combination immediate release tablets/capsules Fixed dose combination extended release capsules Innovative Drug Delivery Technologies Effervescent Formulation (Lubrication optimizations studies) in Formulation (Compression coating) Novel drug delivery systems including Liposomes Dedicated Oncology / High Potency Products Area with Isolators Dermatology product development Labs Process Development Laboratories Process Scale Up Facilities Analytical Testing Laboratories ICH Stability Chambers In-vitro binding Innovation
ACME GENERICS New Dosage Facility (General s/capsules and Levothyroxine s) Available Dosage s & Capsules Approvals EU-GMP Hungary, TGA Australia. US-FDA * Momentum Capacity Facility area 6 Billion s from Levothyroxine Block. 10 Billion s and 2 Billion Capsules from General Block 300000 Sq. ft. * Filing scheduled in Q1 2018
UK HUNGARY NAFDAC NIGERIA UKRAINE Direction de la Pharmacie, du Médicament et des Laboratoires de Côte d lvoire GHANA TANZANIA COLOMBIA National Drug Authority UGANDA IVORY COAST YEMEN FMHACA ETHIOPIA MC AZ ZIMBABWE MINISTRY OF HEALTH & SANITATION SIERRA LEONE Australian Government Department of Health and Ageing AUSTRALIA ANVISA BRAZIL BỘYTÊ VIETNAM MINISTÈRE DE LA SAMTÉ ET DE L ACTION SOCIALE SENEGAL WHO KENYA PHILIPPINES ZAMBIA Accreditations
Product Development Injectable S.No. Name of Product RLD Nature of Product Ampoule/ 1 2 3 4 5 Zovirax Zedbac,Zithromax Cancidas Klaricid NA 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Acyclovir Azithromycin Injection Caspofungin 50mg/ 70 mg Clarithromycin Injection Citicholine Injection 250 mg/ml(2ml/4ml) Preservative Free Colistithemate Sodium Injection 1 M IU/Vial Colistithemate Sodium Injection 2 M IU/Vial Cyanocobalamin Esomeprazole Injection Essential Phospholipid Injection Ketorolac Injection Omeperazole Injection Ondansetron Oxytocin Pantaprazole Injection Rabeprazole Injection Rocuronium Bromide Injection 0.9% Sodium Chloride Injection 5% Sodium Bicarbonate Injection Tranexamic Acid Injection 100 mg/ml(5ml) Tranexamic Acid Injection 100 mg/ml(10ml) Vancomycin Injection(500mg) Vancomycin Injection(1000mg) Voriconazole Injection Colomycin Colomycin Cynocobalamin- American Reagent Nexium Essentiale Ketorolac Trometamol Omeprazole Mylan Zofran Syntocinon Protium, Protonix Rabeloc Zemuron Sodium Chloride Sodium Bicarbonate Cyklokapron Cyklokapron Vanocin,Vancomycin Fresenius Vanocin,Vancomycin Fresenius Vfend Creation Product Development Oral S.No. Name of Product RLD Nature of Product s 1 2 3 4 5 6 7 8 Carbimazole 5 & 20mg Dapsone 50,100mg Levothyroxine Levothyroxine Oral Solution Liothyronin 20mcg Methocarbamol 750mg Metformin SR 500,750, 1000mg Propylthiouracil 50mg Carbimazole Dapsone Eltroxin/Levothyroxine Levothyroxine Tertroxin/Liothyronin Na Methocarbamol Glucophage SR Propylthiouracil
STERILE PORTFOLIO Injections Rocuronium Bromide Injection 50mg Available Cyanocobalamin 1ml, 10ml,30ml Under Development Tranexamic Acid 100 mg/ml(5ml) Available Tranexamic Acid 100 mg/ml(10ml) Available Essential Phospolipids Available Citicholine Inj 250mg/ml Available Ketorolac Injection 30mg Q1 2018 Ondansetron Injection 4mg/8mg Q1 2018 0.9% Sodium Chloride Injection 0.90% Under Development 5% Sodium Bicarbonate Injection 5% Under Development Oxytocin Injection Under Development Injections Esomeprazole 40mg Available Pantoprazole 40mg Available Omeprazole Inj. 40 mg Available Rabeprazole 20mg Available Clarithromycin 500mg Available Azithromycin 500mg Available Voriconazole Inj. 100mg Available Acyclovir Inj. 500mg/ 1g Q2 2018 Vancomycin 500mg, 1000mg Available Teicoplanin 400mg Q2 2018 Tigecycline 50mg Q2 2018 Multivitamin B1-20mg,B2-5mg, B3-40mg,B6-5mg, B12-103mcg Q1 2018 Caspofungin 50mg/70mg Available Colistithemate Sodium Inj. 1 M IU/Vial & 2M IU/ Vial Under Development THYROID MANAGEMENT Levothyroxine s 12.5/25/50/75/ 88/100/ 112/125/ 137/150/200/ 300 mcg Available Levothyroxine Oral Solution Under Development Liothyronin 5mcg, 20mcg, 25mcg, 50mcg Under Development Propylthiouracil 50mg Under Development Carbimazole s 5/10/20 mg Under Development GYNAECOLOGY & FEMALE HORMONAL PRODUCTS Levonorgestrel s 0.75mg/1.5mg Available Mifepristone s 200mg Available Misoprostol s 200mcg/100mcg /25mcg Available Product List Emerging Market Comb kit one Mifepristone, Four Misoprostol s 200mg+200mcg Available Tranexamic Acid & Mefenamic Acid s 500+250mg Tech Pack Norethisterone s 5mg Q1 2018 Tranexamic Acid s 500 mg Available CARDIOVASCULAR DRUGS/HYPERTENSION Atenolol s 25/50/100mg Available Atenolol & Amlodipine s 50+5mg Tech Pack Atenolol and Chlorthalidone s 50+12.5 /100+25 mg Ramipril Capsules/s 2.5/5/10mg Available Losartan Potassium s 25/50mg Available Losartan Potassium & Hydrochlorothiazide s 50+12.5mg Available Losartan Potassium & Amlodipine s 50+5mg & 25+2.5mg Tech Pack Losartan Potassium & Ramipril s 50/2.5 mg + 50/5 mg Tech Pack Amlodipine s 5/10mg Available Olmesartan Medoxomil s 5/20/40mg Q1 2018 Olmesartan Medoxomil & HCTZ s Olmesartan + Amlodipine s 20+12.5mg & 40+25mg Q1 2018 20+5 mg & 40+5 mg Tech Pack Olmesartan + Chlorthalidone s 20+12.5mg & 40+12.5mg Tech Pack Telmisartan s 20/40/80mg Available Telmisartan + Chlorthalidone s 40/12.5mg & 40/6.25mg & 80/12.5mg Tech Pack Telmisartan and HCTZ s 40/80 and 12.5 mg Q1 2018 Atorvastatin s 10/20/80mg Available Atorvastatin + Aspirin Capsules 10/75 mg & 10/150 mg Q1 2018 Atorvastatin + Aspirin + Ramipril Capsules 10/75/5 mg Atorvastatin & Ezetimibe s 10+10mg Q1 2018 Bisoprolol s 5/10mg Available Bisoprolol & HCTZ s 2.5/6.25 & 5/6.25 Tech Pack Bisoprolol + Amlodipine s 2.5+5mg/ 5+5mg Tech Pack Clopidogrel tablets 75 mg Cilnidipine 5/10/20 mg Tech Pack Cilnidipine +Telmisartan s 10+40 mg Tech Pack Pravastatin s 10 mg Q4 2017 CENTRAL NERVOUS DRUGS Zolpidem Tartrate E.R s 6.25/12.5mg Methocarbamol s 750 mg Under Development Dothiepin HCl s 25/50/75mg Alprazolam s 0.25/0.50mg Clonazepam s 0.25/0.50mg Zolpidem s 5/10mg Cinitapride s 1mg Levetiracetam s 250mg/500 mg Available Lacosamide s 50/100/150/200mg ANTIDIABETIC Acarbose s 25/50mg Glibenclamide s 2.5/5mg Tech Pack Glibenclamide & Metformin HCl s 5/500mg Available Gliclazide s 80mg Tech Pack Gliclazide & Metformin s 80/500mg Tech Pack Glimepiride s 1/2/3/4mg Available Glimepiride & Metformin HCl SR s 1+500mg & 2+500mg Available Pioglitazone s 15/30mg Q4 2017 Pioglitazone & Metformin HCl s 15+500mg & 30+500mg Tech Pack Pioglitazone & Glimepiride s 15+1mg & 15+2mg Tech Pack Voglibose s 0.2/0.3mg Tech Pack Voglibose & Metformin s 0.2+500mg & 0.3+500mg Tech Pack Voglibose,Metformin & Glimepiride s 0.2+500+1mg & 0.2+500+2mg Metformin SR s 500mg SR/ 750 SR/1000mg SR Metformin Hydrochloride s 500 mg Available ANALGESICS/PAIN MANAGEMENT Paracetamol s 500/650 mg Tech Pack Paracetamol +Caffeine s 650+32.5 mg Tech Pack Paracetamol+Dicylcomine s 500+20mg Tech Pack Ibuprofen+Paracetamol+ Caffeine Tramadol Hydrochioride Capsules 50mg Available Tramadol Hydrochioride & Paracetamol s 37.5+325 Q1 2018 Ibuprofen & Paracetamol s 400+325mg Tech Pack Diclofenac Sodium S.R. s 100mg Tech Pack Diclofenac Potassium s 50 mg Tech Pack Diclofenac Sodium & Paracetamol s 50+325 mg/50+500mg Available Dicloefenac Potassium & Thiocolchicoside s 50 mg & 4 mg Tech Pack Thiocolchicoside Capsules 4mg/8mg Tech Pack
Etoricoxib s 60/90/120mg Available Etoricoxib + Thiocolchicoside s 60+4mg/ 60+8mg Available Diclofenac Sodium,Chlorzoxazone & Paracetamol s 50,250 and 500 Tech Pack Diclofenac Potassium,Chlorzoxazone & Paracetamol s 50,250 and 325 mg Tech Pack Aceclofenac s 100mg Available Aceclofenac & paracetamol s 100+500mg Available Aceclofenac (S.R) s 200mg Tech Pack Aceclofenac, Paracetamol & Serratiopeptidase s 100+500+10mg Tech Pack Aceclofenac + Thiocolchicoside s 100+4mg/100+8mg Tech Pack Diacerein Capsules 50mg Tech Pack Lornoxicam s 4/8mg Available Lornoxicam & Paracetamol s 4+500mg & 8+500mg Etodolac SR s 600mg Tech Pack Tapentadol SR s 100/150/200mg Tapentadol s 50/75/100mg Tech Pack Dosulepin 25/75mg Tech Pack Celecoxib Capsules 200 mg Dicyclomine + Paracetamol tablets 20mg+500mg Tech Pack Aspirin s 75 mg ANTIBIOTICS Azithromycin DT s 50/100mg Azithromycin s 250/500/1000mg Available Roxithromycin s 150mg Sparfloxacin s 200mg Ofloxacin s 100/200/400mg Tech Pack Ofloxacin & Ornidazole s 200+500mg Tech Pack Ofloxacin & Tinidazole s 200+600mg Ciprofloxacin HCl s 250/500mg Available Ciprofloxacin HCl & Tinidazole s 500+500mg Q1 2018 Fluconazole, Azithromycin & Secnidazole s Combikit 150+1000+1000mg Available Fluconazole & Tinidazole s Combikit 150+1000mg Gatifloxacin s 200/400mg Levofloxacin s 250/500mg Q4 2017 Ornidazole s 500mg Tinidazole s 500mg Available Prulifloxacin s 600mg Gemifloxacin Mesylate s 320mg Balofloxacin s 100mg Clarithromycin s USP 500mg Linezolid s 600 mg Q1 2018 Metronidazole s 500 mg ANTIFUNGALS Fluconazole 50 DT s 50mg Fluconazole s/capsules 150mg Available Fluconazole s 200 mg Available Itraconazole Capsules 100mg Available Clotrimazole s 100mg ANTACIDS/GASTROLOGY/ANTIVERTIGO Omeprazole & Sodium Bicarbonate s 20+1100mg & 40+1100mg Levosulpiride SR Capsules Tech Pack Omeprazole Capsules 10/20mg Available Omeprazole & Domperidone Capsules 20+10mg Tech Pack Lansoprazole Capsules 30mg Available Omeprazole & Domperidone SR Capsules 20+30mg Tech Pack Pantoprazole EC s 20/40mg Available Pantoprazole & Domperidone Capsules 20+10mg Tech Pack Pantoprazole + Itopride Capsules 40+150mg Tech Pack Rabeprazole Sodium & Sodium Bicarbonate as buffer s 20+1100mg /40+1100mg Pantoprazole Sodium with Sodium Bicarbonate as buffer s 20+1100mg /40+1100mg Domperidone s 10mg Tech Pack Dexrabeprazole Sodium Enteric Coated s 5/10mg Balsalazide Disodium Dihydrate Capsules 750mg Tech Pack Levosulpiride s 25mg Tech Pack Levosulpiride SR s 75/100/150/200mg Tech Pack Lafutidine s 5mg/10ng Tech Pack Ondansetron s 4/8 mg Tech Pack Ranitidine s 150 mg Betahistine s 4/8/16 mg Q4 2017 Albendazole s 400mg Q1 2018 HPYLORI KITS Combikit of Clarithromycin/ Tinidazole & Rabeprazole s Combikit of Clarithromycin/ Tinidazole & Esomeprazole s URINARY TRACT RELATED DRUGS Available Available Alfuzosin ER s 10mg Available Terazosin HCl s 1/2/5mg Tech Pack Rabeprazole Sodium s 20mg Available Rabeprazole Sodium & LIVER DRUGS Domperidone SR Capsules 20+30mg Tech Pack Ursodeoxycholic 150/300mg Q1 2018 Rabeprazole & Levosulpiride SR Capsules 20+75mg SR Tech Pack Magaldrate & ANTICOLD/ANTIALLERGIC Simethicone s 400+20mg Esomeprazole s 20/40mg Available Cetrizine Dihydrochloride s 10mg Available Esomeprazole & Levocetrizine HCl s 5mg Available Domperidone Capsules 20+30mg ( SR) Tech Pack Levocetirizine & Esomeprazole & Montelukast Sodium s 5+10mg & 4+2.5mg Q1 2018 Montelukast Sodium s 4/5/10mg Available Levocetrizine Dispersible s 5mg Fexofenadine Hydrochloride s 120/180 mg Q1 2018 Loratadine s 10 mg Q4 2017 VITAMINS & IRON SUPPLEMENTS Ferrous Fumurate (equ. to El. Iron) & Folic s Ferrous Fumurate (equ. to El. Iron 50mg), Folic Acid 0.5mg & Elemental Zinc 20mg s 50+0.5mg 50+0.5+20mg Folic Acid s 5mg Available Ferrous Ascorbate (eq. to elemental iron) & Folic Acid s Ferrous Ascorbate (equ. To elemental iron), Folic Acid & El. Zinc s 50+1.5mg & 100+1.5mg 100+1.5+22.5mg Mecobalamin s 500mcg/1500 mcg Tech Pack ENZYME Serratiopeptidase s 10mg Trypsin Chymotrypsin s 50K/100K/200K Available Armour Unit
ASIA Nepal, Sri Lanka, Philippines, Vietnam, Cambodia, Laos, Thailand, Yemen, Myanmar NORTH AMERICA US (Filing planned in Q1 2018), Canada SOUTH ANERICA Brazil, Colombia, Guatemala, Nicaragua, Paraguay, Uruguay, Chille, Costa Rica, Venezuela, Peru EUROPE United Kingdom, Hungary CIS Kazakhstan, Uzbekistan, Ukraine ANZ Australia GIANT STRIDES TOWARDS A GLOBAL FOOTPRINT AFRICA Ethiopia, Nigeria, Ghana. Tanzania, Kenya, Uganda, Zambia, Malawi, Sierra Leone, Madagascar, Angola, Zimbabwe, Mozambique, Cameroon, Senegal, South Sudan Footprint Acme Formulation Pvt. Ltd. Ropar Road, Nalagarh, Distt. Solan (H.P.) - 174 101 Mobile No. : +91 98160-62744 Board Lines : +91 1795-308001 Direct Lines : +91 1795-308006 E-mail : viralshah@acmeformulation.com Acme Generics LLP Plot No. 115, HPSIDC Industrial Area Davni, P.O. Gurumajra, Tehsil Nalagarh, Distt. Solan (H.P.) - 174 101 Board Lines : +91 1795-332601 Direct Lines : +91 1795-332606 E-mail : viral@acmegenerics.in Immacule Lifesciences(P) Ltd. India Village Thanthewal, Ropar Road,Nalagarh, Distt. Solan (H.P.) - 174 101 Mobile No. : +91 98160-62744 Tel : +91 1795-331406 E-mail : viral@immacule.in Veritas Research Inc. 75-A, 15th cross, 1st phase, J.P. Nagar, Bengaluru, Karnataka 560078 Tel : +91 80-42627200 Fax : +91 80-26640683 www.veritasresearch.in