Top Five Indian Pharmaceutical Manufacturers in United States Pharmaceutical Market

India is the one of the biggest supplier of generic medicines to USA. India and USA are strong relationship while we talk about pharmaceutical and healthcare sector. India is second largest supplier of generic medicines to USA where as USA add 40 percent in total revenue of top four Indian Pharmaceutical manufacturers.

In recent time, due to change of US import policy has impacted Indian Pharmaceutical Exporter to USA. US administration’s policy of reducing import has created trouble for these exporters. Although these manufacturers have their own plants in USA but there major revenue portion come from importing medicines from India. After change in import policy of USA, Indian Pharmaceutical Companies has to change its policies and has to increased acquisition and merger of USA Pharmaceutical Companies or setting-up more manufacturing facilities in USA to keep their presence into US pharmaceutical Market.

Top Five Indian Pharmaceutical Manufacturers who has their own plants in USA:

1. Sun Pharma
Sun Pharma is 4th largest Speciality Generic Pharmaceutical Company in world having its operation in More than 150 countries and 5 continents. Sun Pharma is also largest Indian Pharma Company in the US. The Company was established by Dilip Shangvi in 1983. The company has strong presence into American Generic Market and has become Brand in US. Sun Pharma has 45 (API and Finished Goods) manufacturing unit across world. These manufacturing units are located in India, the US, Brazil, Canada, Egypt, Hungary, Israel, Bangladesh, Mexico, Romania, Ireland, Morocco, Nigeria, South Africa and Malaysia. In US, Sun Pharma has 7 own finished goods manufacturing units and one API manufacturing unit. These units are located in Philadelphia, Detroit, Wilmington, Chicago, Cranbury, New Brunswick, North Brunswick and API unit is located in Chattanooga. Sun Pharma first created its presence in US pharma market in 1996.

2. Lupin

Lupin Pharmaceuticals, Inc. entered the U.S. generic pharmaceutical market in 2003 with the ANDA approval for Cefuroxime Axetil Tablets. Since then Lupin has received more than 75 FDA approvals and have become one of the fastest growing pharmaceutical companies in the US. Lupin Limited, has its headquartered in Mumbai, India founded by Desh Bandhu Gupta.
The United States remains Lupin’s largest and most important market with 48% share of total revenues. In March 2016, the Company completed its acquisition of US-based GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS). The Somerset, New Jersey is the Company’s first manufacturing site in the US. In FY 2017 Lupin’s US revenues surpassed the USD 1 billion mark, closing at USD 1,207 million, a growth of 37% over FY 2016 revenues of USD 883 million. The revenues from Lupin’s Brands business were USD 78 million, while the Generics business clocked in revenues of USD 1,129 million. 

Dr. Reddy’s Laboratories is a Hyderabad, Telangana based Indian multinational pharmaceutical company founded in 1984 by Dr. K. Anil Reddy. Dr Reddy’s supplies Generic medicines to more then 80 countries world wide. In the year 1997, Dr. Reddy filled first ANDA with the United States Food and Drug Administration for Ranitidine. Dr. Reddy became the first Indian company to win 180-day exclusivity for a generic drug in the US. Also, Dr. Reddy launched their first generic product, Ranitidine, in the US market. In the year 2003, Dr. Reddy launched Ibuprofen, first generic product to be marketed under the ‘Dr. Reddy’s’ label in the US. During the year 2010-11, the company acquired GlaxoSmithKline’s (GSK) oral penicillin manufacturing facility located in Tennessee, USA. Dr. Reddy has its three manufacturing units in USA located at Shreveport (Louisiana), Bristol (Tennessee) and Middleburgh (New York). Dr. Reddy’s Laboratories Inc. has its American office located in Princeton, New jersey.

4. Cipla
Cipla is an Indian Multinational Pharmaceutical having its headquarter in Mumbai, India founded by Dr. Khwaja Abdul Hamied as The Chemical, Industrial and Pharmaceutical Laboratories in 1935 which is then shorted to Cipla ltd in 1984. Cipla has its presence in more than 100 countries. Cipla USA Inc., the US subsidiary of Cipla Limited, is based in Miami, FL. Cipla started US market in 1985, when Cipla became the first Indian company to receive US FDA approval. Cipla has place in top fifteen generic pharmaceutical companies in USA. Cipla completed acquisition of InvaGen Pharmaceuticals Inc. and Exelan Pharmaceuticals Inc. in USA to increase its presence.  InvaGen has 3 manufacturing units with ~350,000 sq.ft. manufacturing and R&D area and about 500 employees specialized in different fields. 

Aurobindo Pharma Limited is an Indian Pharmaceutical having its headquarter in HITEC city, Hyderabad, India founded in 1986 by P.V. Ramprasad Reddy and K. Nityananda Reddy. Aurobindo Pharma USA Inc. operates as a subsidiary of Aurobindo Pharma Limited manufactures generic pharmaceutical drugs. The company was incorporated in 2004 and is based in Dayton, New Jersey.  Aurolife is a 100% owned subsidiary of Aurobindo Pharma USA Inc (APUSA) has 100,000 square feet state-of-the-art US FDA approved cGMP compliant manufacturing facility. 

Hope above information is Helpful to you…
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Pharmaceutical Companies have to be registered under IPDMS system

NPPA is developing an Integrated MIS application for capturing Form 1-5 of DPCO, 2013 on line from Pharmaceutical Manufacturer/ Marketing/ Importer/ Distributor Companies. The system would only be accessed by authorised users. Each company is provided a login id and password on the basis of registration information.

National Pharmaceutical Price Authority (NPPA) has issued a notice to all pharmaceutical associations. NPPA warns that it will constrained to take appropriate action against their member companies who have yet to register in the Integrated Pharmaceutical Database Management system (IPDMS).

IPDMS is a system which aims at facilitating online submission of mandatory returns/reports under the DPCO 2013 by manufacturers, including companies which make, import and market drugs for distribution or sale in the country. IPDMS has been developed by DPCO with collabration with National Infomatic Centre.

NPPA will be launching this system shortly. NPPA has urged the associations to impress upon their members companies to register themselve with IPDMS immediately. From top 100 companies, 59 companies have not yet registered for this. NPPA issued notice dated May 1 and has alerted to take appropriate actions against non-registered pharma companies under provision of DPCO 2013 read along with the Essential Commodities Act, 1955.

Nearly 300 pharma companies has been registered with this system covering more than 20000 formulation packs. Well known companies like cadila pharma, Dr Reddy’s lab, Mankinkind pharma, MSD, Cipla etc are not registered yet for IPDMS.

According to NPPA, “Availability of reliable database is a necessary pre-requisite for carrying out the functions of price fixation and price revision with respect to scheduled drugs; price fixation with respect to new drugs; monitoring the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulations; and monitoring the prices of non-scheduled formulations.”

Online Registration under IPDMS includes company details, head office/corporate office address, contact person details, product source details and product details etc.

As per the IPDMS, pharma manufacturers have register online which has been initiated by the NPPA. The initial target date for implementation of the system was by October last year.

Indian Pharmaceutical Market March Review

One of my friend send me following detail through whats app… It was interesting so I decide to share it with you about Indian Pharmaceutical Market:

IPM clocked 7389 Crs in March 2015 and grew at 20.9% in March 2015
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Leading Companies:
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For the month of March 2015, among the top 10, Lupin grew by 32.4% followed by Macleods at 31.7% & Mankind at 28.7%
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22 co’s crossed the growth of IPM in March 2015 among top 50
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Among the top 50 Co’s, Akumentis has the highest growth of 74.0% followed by Wockhardt at 44.0% & Allergan at 39.3 %
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46 Co’s showed growth of more than 10% among the top 50
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Among the 11-20 ranked Co’s Aristo has the highest growth of 36.9% followed by Sanofi at 30.8% & Torrent at 30.5%
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Among the 40-50 ranked Co’s, Allergan has the highest growth at 39.3% fllowed by Apex at 19.0% & Hetero at 18.2%.
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Among the 51-60 ranked Co’s Eli Lilly grew at 40.3% followed by Troikaa at 32.2% & Systopic at 30.4%
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Among the 61-70 ranked Co’s, Fresenius Kabi grew at 117.7% followed by Boehringer grew by 101% followed by UCB at 36.1%
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GSK enters the 3000 Cr Club as on MAT 2015
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Indian V/S MNCs:
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Indian companies have grown at 21.0% versus 20.9% for MNCs in March 2015
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Among the top 50 in MNCs Allergan grew by 39.3% followed by Sanofi at 30.8% & Merck at 30.6%
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Under the Non-NLEM category Indian Co’s grew at 15,6% whereas MNCs grew at 22.1%
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DPCO, Non DPCO & Non-Scheduled Para 19 Market:
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The DPCO containing molecules market grew at 1.6 % whereas the non DPCO market grew by 21.7% & Non -Sch Para 19 Market at 15.6% resulting in an overall growth of 20.9% for March 2015.
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NLEM & Non – NLEM Category showed unit growth at 9.5% and 13.0% respectively. The Non-Sch Para 19 Market grew at 13.2% from units perspective
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The DPCO 2013 portfolio for Pfizer grew at 25.6%, Ranbaxy at 27.6%, GSK at 12.2% & Abbott 15.5%
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Therapy Areas:
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From therapy perspective 8 therapies have outgrown the IPM growth & all therapies have double digit growths
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Respiratory Market grew at 27.8%, Gastrointestinal market grew at 23.4% , Pain & Analgesics market grew at 16.5% whereas Anti-infectives grew at 22.0%
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Anti-diabetic market grows at 32.9% & Cardiac at 19.1% in chronic business
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Derma market grew by 19.2% & Urology Market at 29.5%
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Regional Dynamics:
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From regional perspective 13 regions have outgrown the IPM growth
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UP East market grew the highest at 35.5% followed by Tamil Nadu market at 29.7% & North East Market at 28.9%
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No regions had negative growth in March 2015

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Molecules:
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Amoxycillin + Clavulanic Acid Market grew at 27.9% whereas Glimepiride + Metformin grows at 21.9% at No 2.
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Paracetamol grew at 26.7%, Atorvastatin – 17.5%, Probiotic Microbes at 21.3%, Cefixime – 28.7%, Pantoprazole – 17.7%, Montelukast + Levocetrizine at 35.0%, Glimepiride + Metformin + Pioglitazone at 26.7%, Vitamin-D at 36.7%, Hydroquinone + Mometasone + Tretinoin at 15.4%, Voglibose + Metformin + Glimepiride at 65.7%, Rosuvastatin at 24.7%, Protein Supplements at 26.5%
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Brands:
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Mixtard continues to lead the pack with 36 Crs for the Month of Mar -15
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Monocef grew at 60.2%, Augmentin at 42.5%, Glycomet-GP grew at 33.3%, Mixtard at 28.7% & Becosules at 24.1% among the top 10 Brands
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Few Brands who have gained ranks include Pentaxim (+454), Electral Powder (+158), Januvia (+68), Janumet (+59), Spasmoproxyvon Plus (+53), Panderm Plus (+51), Monocef – O (+44), Shelcal (+41), Jalra-M (+36), Tonact (+24), Dolo (+10), Taxim (+9), among top 100 Brands over Mar -14
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New Launches in IPM:
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Total 185 Brands & 313 SKUs launched in March 2015
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Top New Brands for March are Variped, Yondelis & Ozurdex.