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Ranbaxy Laboratories

Executive Summary

Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company, producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. The Company is ranked amongst the top ten global generic companies and has a presence in 23 of the top 25 pharma markets of the world. The Company with a global footprint in 49 countries, world-class manufacturing facilities in 11 and a diverse product portfolio, is rapidly moving towards global leadership, riding on its success in the world’s emerging and developed markets.

Ranbaxy Laboratories Ltd. officially ceased to exist as a company in 2014, when Sun Pharma acquired it. 

History of Ranbaxy

Ranbaxy was started by Ranbir Singh and Gurbax Singh in 1937 as a distributor for a Japanese company Shionogi. The name Ranbaxy is a portmanteau of the names of its first owners Ranbir and Gurbax. Bhai Mohan Singh bought the company in 1952 from his cousins Ranbir and Gurbax. After Bhai Mohan Singh’s son Parvinder Singh joined the company in 1967, the company saw an increase in scale.

In the late 1990s, Ranbaxy formed a US company, Ranbaxy Pharmaceuticals Inc., and to support its entry into the pharmaceutical market in United States.

In June 2008, Daiichi-Sankyo acquired a 34.8% stake in Ranbaxy from the family of CEO and Managing Director Malvinder Mohan Singh for USD 2.4 billion.

In November 2008, Daiichi-Sankyo completed the takeover of the company from the founding Singh family in a deal worth $4.6 billion by acquiring a 63.92% stake in Ranbaxy. Ranbaxy’s Malvinder Singh remained as CEO after the transaction. The addition of Ranbaxy Laboratories extended Daiichi-Sankyo’s operations, with the combined company worth about US$30 billion.

In 2009 it was reported that former Novartis Senior Vice-President Yugal Sikri would lead the India operations of Ranbaxy Laboratories.

In 2011, Ranbaxy Global Consumer Health Care received the OTC Company of the year award. In the 2012, 2013 and 2014 Brand Trust Reports, Ranbaxy was ranked 161st, 225th and 184th respectively among India’s most trusted brands.

On 7 April 2014 India based Sun Pharmaceutical and Japan based Daiichi Sankyo jointly announced the sale of the entire 63.4% share from Daiichi Sankyo to Sun Pharmaceutical in a $4 billion all-share deal. Under these agreements, shareholders of Ranbaxy, were to receive a 0.8 share of Sun Pharmaceutical for each share of Ranbaxy. After this acquisition, the partner Daiichi-Sankyo was to hold a stake of 9% in Sun Pharmaceutical.

Subsidiaries of Ranbaxy Labs:

As Sun Pharma has effectively acquired Ranbaxy Labs, its subsidiary companies are: 

Popular Pharmaceutical Products of Ranbaxy

The top products of Ranbaxy, with their therapeutic areas:

Abiraterone acetate* Anti-Cancer
Acamprosate Calcium CNS Stimulant
Acitretin Dermatology
Adapalene  Retinoid agent
Adefovir Dipivoxil AntiViral
Alendronate Sodium Anti-Osteoporosis
Amifostine Trihydrate* Radioprotective agent
Amisulpride Anti-Psychotic
Amorolfine Hydrochloride Dermatology
Amoxicillin Trihydrate Antiinfective
Anastrozole Anti-Cancer
Aripiprazole* Anti-Psychotic
Asenapine Maleate* Anti-Psychotic
Atazanavir Sulfate AntiViral
Atomoxetine HCl* ADHD Therapy
Atorvastatin Calcium Amorphous Cardiovascular
Atorvastatin Calcium Crystalline Cardiovascular
Atosiban Acetate Oxytocin Antagonist
Azacitidine Anti-Cancer
Benazepril Hydrochloride Cardiovascular
Bendamustine* Anti-Cancer
Bicalutamide Anti-Androgen
Bivalirudin* Anti-Coagulant
Bortezomib* Multiple Myeloma
Bosentan Monohydrate Cardiovascular
Budesonide Anti-Inlammatory Steroid
Buprenorphine HCl Analgesic
Bupropion HCl Anti-Depressant
Calcipotriol Anhydrous Psoriasis
Calcitonin (Salmon) Anti-Osteoporosis
Candesartan cilexetil Cardiovascular
Capecitabine Anti-Cancer
Carboplatin Anti-Cancer
Carvedilol Anti-Hypertensive
Cefaclor Antiinfective
Cefdinir Antiinfective
Cefpodoxime proxetil Antiinfective
Cefprozil Antiinfective
Cefuroxime Axetil Antibiotic
Celiprolol Hydrochloride Cardiovascular
Cephalexin Antiinfective
Cilastatin sodium sterile Antiinfective
Cilazapril Cardiovascular
Cinacalcet HCl* Calcimimetic
Ciprofloxacin Antiinfective
Ciprofloxacin Hydrochloride Antiinfective
Cisplatin Anti-Cancer
Citalopram Hydrobromide CNS
Clarithromycin Antiinfective
Clarithromycin Granules 27.5% Antiinfective
Clarithromycin Granules 43.75% Antiinfective
Clomipramine HCl Anti-Depressant
Clonazepam Anti-Epileptic
Clopidogrel Bisulphate Anti-Thrombotic
Clorazepate Dipotassium Anxiolytic
Colesevelam* Bile acid Sequestrant
Dabigatran Etexilate Mesylate* Anti-Coagulant
Decitabine Myelodysplastic Syndrome
Deferasirox* Iron Chelator
Desloratadine Anti-Histaminic
Desmopressin Acetate Vasopressin Analogue
Desvenlafaxine Fumarate Anti-Depressant
Divalproex Sodium Anti-Epileptic
Dobutamin HCl Cardiovascular
Donepezil HCl Anti-Alzheimer
Doripenem Antiinfective
Dothiepin HCl Anti-Depressant
Doxercalciferol* Hyperparathyroidism
Doxycycline Antiinfective
Doxycycline Hyclate Antiinfective
Dronedarone Anti-Arrhythmic
Drospirenone Oral Contraceptive
Duloxetine Anti-Depressant
Dydrogesterone Hormone Replacement Therapy
Edaravone Neuroprotective
Emtricitabine AntiViral
Entecavir AntiViral
Epinastine HCl Anti-Histaminic
Epinephrine Neurotransmitter
Epoprostenol Sodium Prostaglandin
Eptiibatide* Anti-Thrombotic
Escitalopram Oxalate Anti-Depressant
Esomeprazole Magnesium (Amorphous) Gastrointestinal
Esomeprazole Sodium Proton pump inhibitor
Eszopiclone Hypnotic
Exemestane Anti-Cancer
Exenatide * Anti-Diabetic
Febuxostat Form G Antigout
Fesoterodine Fumarate* Overactive bladder
Fexofenadine Hydrochloride Antihistamine
Finasteride Anti-Testosterone for BPH
Fingolimod Hydrochloride* Immuno modulator
Flupirtine Maleate Analgesic
Flurbiprofen NSAID
Fluticasone Propionate Anti-Allergic
Fluvastatin sodium Cardiovascular
Fluvoxamine Maleate Anti-Depressant
Fosamprenavir Calcium AntiViral
Fosinopril sodium Cardiovascular
Fosphenytoin Sodium Anti-Epileptic
Fulvestrant Anti-Cancer
Gabapentin Anti-Epileptic
Galantamine Hydrobromide CNS
Ganirelix Acetate* GnRH Antagonist
Gemcitabine HCl Anti-Cancer
Granisetron HCl Anti-Emetic
Ibandronate Sodium Anti-Osteoporosis
Imatinib Mesylate * Anti-Cancer
Imipenem Antiinfective
Irbesartan Cardiovascular
Irinotecan Anti-Cancer
Isotretinoin Dermatology
Lacosamide* Anti-Epileptic
Lamivudine AntiViral
Lansoprazole Gastrointestinal
Lenalidomide* Anti-Cancer
Lercanidipine HCl Anti-Hypertensive
Letrozole Anti-Cancer
Leuprolide Acetate Anti-Cancer
Levalbuterol HCl Anti-Asthmatic
Levalbuterol Tartrate* Anti- Asthmatic
Levetiracetam Anti-Epileptic
Levocetirizine di HCl Anti-Histaminic
Levofloxacin Antiinfective
Levosulpiride Anti-Psychotic
Linagliptin * Anti-Diabetic
Liothyronine Sodium Hormone Replacement Therapy
Lisinopril Cardiovascular
Lopinavir AntiViral
Loratadine Antihistaminic
Lorazepam CNS
Losartan Potassium Anti-Hypertensive
Loteprednol Etabonate Corticosteroid
Lubiprostone * Laxative
Lurasidone HCl Schizophrenia
Magnesium Valproate Anti-Epileptic
Meloxicam NSAID
Memantine HCl Anti-Alzheimer
Meropenem Antiinfective
Mesalazine/Mesalamine Anti-Inlammatory
Metadoxine Alcohol Abuse
Metformin HCl Anti-Diabetic
Methyl Phenidate HCl CNS Stimulant
Metoprolol Succinate Anti-Hypertensive
Metoprolol Tartrate Anti-Hypertensive
Midazolam CNS
Mifepristone Abortifacient
Milnacipran Hydrochloride CNS
Mirtazapine Hemihydrate Anti-Depressant
Montelukast Sodium Anti-Asthmatic
Naloxone HCl Opioid Antagonist
Naltrexone HCl Opioid Antagonist
Naratriptan HCl Anti-Migraine
Nevirapine AntiViral
Octreotide Acetate Anti-Cancer
Ofloxacin Antiinfective
Olanzapine Anti-Psychotic
Olopatadine HCl * Anti-Allergic
Omeprazole Magnesium CNS
Ondansetron Base Anti-Emetic
Ondansetron HCl Anti-Emetic
Orlistat Antiobesity
Oxaliplatin Anti-Cancer
Oxcarbazepine Anti-Epileptic
Oxetacaine Local-Anaesthetic
Paliperidone* Anti-Psychotic
Pamidronate Disodium Anti-Osteoporosis
Pantoprazole Sodium Sesquihydrate Proton pump inhibitor
Paroxetine HCl Anti-Depressant
Pemetrexed Disodium* Anti-Cancer
Pentazocine CNS
Pentoxifylline Anti-Anginal
Phentermine HCl Appetite Suppressant
Pioglitazone Hydrochloride Antidiabetic
Pramipexole Di HCl Anti-Parkinsons
Pramlintide Acetate Anti-Diabetic
Prasugrel Hydrochloride* Anti-Platelet
Pregabalin* Anti-Epileptic
Quetiapine Fumarate Anti-Psychotic
Quinapril Hydrochloride Cardiovascular
Rabeprazole sodium Gastrointestinal
Ramipril Cardiovascular
Ranitidine Hydrochloride Antihistaminic
Ranolazine Anti-Angina
Rasagiline Mesylate* Anti-Parkinsons
Repaglinide Antidiabetic
Rifaximin Anti-bacterial
Riluzole Amyotrophic lateral sclerosis
Risedronate Sodium Anti-Osteoporosis
Risperidone Anti-Psychotic
Ritonavir AntiViral
Rivastigmine Base Anti-Parkinsons
Rivastigmine Tartrate Anti-Parkinsons
Rizatriptan Benzoate Anti-Histamine
Rosuvastatin Calcium* Lipid lowering agent
Sertraline Hydrochloride Form I CNS
Sevelamer Carbonate* Hyperphosphatemia
Sevelamer HCl* Hyperphosphatemia
Simvastatin Cardiovascular
Sodium Valproate Anti-Epileptic
Solifenacin Succinate Antimuscarinic
Sumatriptan Succinate Anti-Migraine
Tadalafil Others
Tamsulosin Hydrochloride Urology
Telmisartan Cardiovascular
Temozolomide Anti-Cancer
Tenofovir Disoproxil fumarate AntiViral
Teriparatide Anti-Osteoporosis
Terlipressin Acetate Vasopressin Agent
Testosterone Cypionate Hormone Replacement Therapy
Tiagabine HCl Anti-Epileptic
Tizanidine HCl Muscle Relaxant
Tolterodine tartrate Antimuscarinic
Topiramate Anti-Epileptic
Tramadol HCl Opioid Analgesic
Valacyclovir Hydrochloride AntiViral
Valgancyclovir Hydrochloride (Amorphous Grade) AntiViral
Valgancyclovir Hydrochloride (Crystalline Grade) AntiViral
Valproic Acid Anti-Epileptic
Valsartan Cardiovascular
Venlafaxine Hydrochloride CNS
Voglibose Antidiabetic
Voriconazole Antifungal
Zoledronic Acid Anti-Osteoporosis
Zolmitriptan Anti-Migraine
Zolpidem Tartrate CNS
Zonisamide Anti-Epileptic

Product Recalls and Lawsuits

  1. In March 2015, Ranbaxy Laboratories Ltd was sued in a district court in the United States for allegedly manipulating U.S. Food and Drug Administration rules for years to keep rival generic drugs out of the market. The suit alleged that Ranbaxy filed “grossly inadequate” applications seeking approval for its drugs and deceived the FDA into granting approvals and giving the company market exclusivity. 
  2. In May 2013, Ranbaxy pleaded guilty to federal drug safety violations and paid $500 million in fines to resolve claims that it sold subpar drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India.
  3. In 2012, Ranbaxy issued a voluntary retail-level recall for Atorvastatin calcium tablets (Lipitor) because it contained glass particles. Class action lawsuits were filed in New Jersey, United States. 
  4. In 2014, Ranbaxy issued a recall for Atorvastatin calcium after a pharmacist found a 20-milligram tablet in a sealed bottle marked for 10-milligram tablets, the U.S. Food and Drug Administration (FDA) said on its website.
  5. In 2015, Ranbaxy Laboratories Ltd. recalled nearly 30,000 packages of an allergy relief medication – loratadine and pseudoephedrine sulphate packages – that made its way to the United States in February. The U.S. Food and Drug Administration noted that the product was recalled as the result of defective packaging.
  6. In 2015, Ranbaxy’s parent company Sun Pharma voluntarily recalled 200 vials of its cancer drug, gemcitabine, in the United States. This was because of lack of assurance of sterility of the vials. 

Litigation Settlements

  1. In 2010, Ranbaxy Laboratories Limited and Ranbaxy USA agreed to settle a whistleblower lawsuit and will pay a record $500 million in fines and penalties. This is the largest financial penalty levied against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act. The violations revolve around safety violations that occurred at Ranbaxy USA, a subsidiary of the generic pharmaceutical manufacturer Ranbaxy Laboratories. They generic drug manufacturer is accused of allowing tainted drugs from two manufacturing facilities in India to be distributed within the United States market. As part of the settlement, Ranbaxy agreed to pay to a fine and forfeiture of $150 million, as well as an additional $350 million penalty to settle the civil claims that they submitted false statements to Medicaid, Medicare and other government healthcare programs. Approximately $49 million of the penalty will go to the whistleblower.
  2. In 2014, Ranbaxy Laboratories paid $39.75 million in tranches to the state of Texas in the U.S. to settle the litigation concerning its participation in the Texas Medicaid Program.
  3. In 2013, Ranbaxy paid around $420,000 to the U.S. state of Idaho as part of a $500-million settlement that the drug firm had signed with U.S. authorities.
  4. In 2017, Ranbaxy Laboratories agreed to settle lawsuits accusing it of accepting payments from pharmaceutical company Cephalon Inc to delay the release of a generic version of the latter’s wakefulness drug Provigil.
  5. In 2008, Ranbaxy settled with pharma giant AstraZeneca in an agreement that will keep Ranbaxy’s generic copies of the blockbuster heartburn drug Nexium off the U.S. market until 2014.
  6. In 2009, Ranbaxy Laboratories was been slapped with tough penalties by the US Food and Drug Administration (FDA) after it was repeatedly caught falsifying data from one of its four Indian manufacturing plants.

Sources:

https://www.cnbc.com/id/100261384

https://www.abrahamwatkins.com/blog/2012/11/ranbaxy-pharmaceuticals-drug-recall.shtml

https://www.nature.com/news/2009/090302/full/news.2009.130.html

https://www.wsj.com/articles/SB120824391214015579

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=878399

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.