Thirty to 40 new bulk drug units, involving huge investments, will be coming up in the country in near future. While majority of these major bulk drug and intermediate manufacturers are either setting up new units or expanding existing facilities, there are also quite a few new bulk drug facilities coming up in Gujarat, Maharashtra, Punjab and Andhra Pradesh.
As per the information available with Pharmabiz, the Environmental Impact Assessment Division (IA) of the Ministry of Environment & Forests has given clearance to about 20 bulk drug projects in the country, since March 2 2006. Another 20 projects are pending for approval with the IA.
Ind-Swift Laboratories has got clearance for expanding its bulk drug unit at the village of Bhagwanpur in Patiala with a capacity production of 405 tonnes per annum with an additional investment of Rs 18.35 crore. The unit is to manufacture Clarithromycine, Azithromycine, Roxithromycine, Letrozole, Anastrazole, Rosuvastatin Calcium, Fexofenadine Hydrochloride, Fax -10, Atorvastatin Calcium, AT-1 Pure, A-3 from A-2, T-4, Clopi-6, Clopidogrel Bisulphate, T-4, A-3, Pentazocine, Pentazocine-5, Venlaflazine Hydrochloride, Ropinerole, Pioglitizole Hydrochloride, Acamprosate Calcium, Azamine and Clari Granules. The company is also expanding its manufacturing facility at Samba village in Jammu with Rs.10.36 crore to manufacture Roxithromycine (30 TPA), Pentazocine (1.2 TPA), Nitazoxzamide (24 TPA), Azithromycine (18 TPA), and Ezetimbe (0.6 TPA), Atorvastatin Calicium (9 TPA), Clopidogrel Hydrogen Sulphate (36 TPA) and Clarithromycine (12 TPA).
Another bulk drug major Aarti Drugs Limited is expanding its manufacturing facility at Palghar in Thane district of Maharashtra by spending about Rs 1.82 crore. Production capacity after expansion will be 60MTPM of Tinidazole, 35 MTPM of Nimesulide, 15 MTPM of Imidazole intermediates, 200 MTPM of 2-Methyl, 4,5, Nitro immidazole and 1600 MTPM of Ammonium sulphate. In the existing unit, the company is manufacturing Tinidazole, 2 Methyl imidazole sulphate (2-MES), 2-MNI(2-methyl, 5-nitro immidazole sulphate (2-MIS), 2-MNI(2-methyl,5-nitro immidazole), Liquor ammonia and ammonium sulphate. Meanwhile, the Environment Ministry is yet to clear two pending applications from Aarti Drugs Ltd to set up two bulk drug manufacturing plants at MIDC, Tharapur near Thane.
Cipla, the third largest drug maker in India, is also expanding its bulk drug manufacturing facility at MIDC Industrial area at village Kurkumbh in Pune. The production capacity of the existing unit is 56.6 MPTA for manufacturing of 9 products. To this, 30 more products will be added. Four existing products - Nabumetone, Propanolol hydrochloride, Lamotrigine and Estramustine sodium phosphate will be removed. The plant will manufacture 160 MPTA of Ciprofloxacin hydrochloride, Fluconazole, Meloxicam, Norfloxacin, Salbutamol sulphate, Fliticasone propionate, Celecoxib olanzapine, Ondansetron hydrochloride, Pamidronic acid/disodium, Pioglitazone hydrochloride, Rammipril, Carvedilol, Alendronate sodium trihydrate, Sertraline hydrochloride, Rofecoxib, Natexiglinide, Zolpidem tartrate, Losartan potassium, Pramipexole dihydrochloride, Paroxetine hydrocloride, Mometasone furoate, Formoterol fumarate, Loteprednol etabonate, Budesonide, Famciclovir, Lamivudine, Citalopram hydrobromide, Rizatritfan benzoate, Clopidogrel bisulphate, Ziprasidone hydrochloride, Aripiprazole, Beclomethasone dipropionate, Quetipine fumerate and Sibutramine hydrochloride. All the 35 products will not be manufactured at a time. Land area of the project is 16.0 ha. of which 12.0 ha has been earmarked for green belt development. Cost of the expansion project is Rs. 25 crores.
Lupin, another drug major, is expanding capacities of its two bulk drug plants in Madhya Pradesh and Maharashtra. Lupin's plant at village Pasthal in Palghar near Thane will be expanded with an investment of Rs.20 crore. Plans are to manufacture Pravastatin, Compactin, Simvastatin, Lansoprazol, Pentaprazol, Zolpidem tartarate, Venlafaxin, Setraline, Refaximin and Rifapentene at this plant. Lupin also has got clearance to expand the capacity of its bulk drug unit at Mandideep, in Madhya Pradesh from the existing capacity of 285 TPA to 814 TPA with an investment of Rs.19.75 crore. The unit manufactures Cephalexin, Cefadroxil, Lisinopril, Cefixime Trihydrate, Cefdinir, Cefpodoxime Proxetil, Ceftiofur Sodium and Cefproxil Monohydrate.
Vedant Drugs and Fine Chemicals Pvt. Ltd. got clearance to set up a new bulk drug unit at Ambernath in Maharashtra with an investment of Rs.12 crore. Plans are to manufacture Parahydroxy phenyl acetamide, Clarithromycine, Roxythromycin, Orthro nitro benzaldehyde, Avobenzane and Octyl methoxy Cinnomate.
Emmellen Biotech Pharmaceuticals Ltd. (EBPL) also got clearance for expanding production capacity of Ephedrine hydrochloride from 200 MTPA to 500 MTPA and Pseudo Ephedrine Hydrochloride from 100 MTPA to 300 MTPA at its plant in Mahad Industrial Estate of Raigad district, Maharashtra. The expansion will be carried out with a total cost of Rs. 12 crore.
Hindustan Latex Limited got clearance to set up a new bulk drug plant at village Kanagala in Belgaum of Karnataka to manufacture 1000 kg/annum of Centchroman. The unit will be set up within the existing premises of HLL and investment on the unit is Rs.3.70 crore. Mahima Exports Pvt Limited got clearance to set up a bulk drug plant at Sonepat in Haryana with a total capacity of 2701 TPA. Investment is to the tune of Rs.40 lakhs. Similarly, Tristar Pharmaceuticals Pvt Limited is setting up a new bulk drug unit at Panchkula in Haryana to manufacture 6 TPA of Vitamin B2-5 phosphate sodium with an investment of Rs. 81.99 lakh.
Varahi Pharmachem is setting up a new plant at Ankleshwar in Gujarat to manufacture 30 PM of magnesium hydroxide (IP), 54 MTPM of Magnesium hydroxide paste, 30TPM of dried Aluminium hydroxide Gel (IP) and 54 TPM of Aluminium hydroxide Gel (IP) with an investment of Rs.45 lakhs. Hem Deep Organics Pvt Limited in Ankleshwar is setting up a bulk drug unit to manufacture 10MTPM of Acyclovir, 10MTPM of Tinidazole, 2.5 MTPM of Tizanidine, 7.0 MTPM of oxyclonazide and 20.0 MTPM of furosemide and the project cost is about Rs. 1.17 crore.
Kalvik Laboratories Pvt. Ltd got clearance to set up a new bulk drug unit to manufacture 300kg/m of 3-Hydroxy-2-Methyl-4-Pyrone and 500kgs/m of 3-Hydroxy-2-Ethyl-4-Pyrone at Medak in Andhrapradesh with an investment of Rs.1.87 crore. Similarly, Biochemical and Synthetic Products Limited will set up a new bulk drug unit at Jeedimetla village in Rangareddy district of Andhra Pradesh to manufacture Bacteriological Peptone with an investment of about Rs. 86 lakhs.
Lakshmi Organics Pvt Limited is expanding its bulk drug unit at Krishna district in Andhra Pradesh with an investment of about Rs.85 lakhs. The clearance is to manufacture fluconazole CIS Bromo Bezoate, 3-Benzoyl Acrylic acid, Tramadol Hydrochloride, Ketoconazole, 2-Chloro Methyl-4-Methoxy-3, Di-methyl Pyridine and Cis- Tosylate.
Proposals for 20 bulk drug manufacturing facilities are being scrutinised by the Environmental Impact Assessment Division (IA) of the Ministry of Environment & Forests. Main among them is the proposal from Dr.Reddy's lab to set up four new facilities at its Unit 4 in Jeedimetla, Srikakulam(Unit-6), Peddadovallapalli village in Nalgonda(unit-5) and S.V. Co-operative Industrial Estate Bollaram in Medak (unit-2&3). As pharmabiz reported, investment in these units would be to the tune of Rs.100 million. Among the other drug majors, WockHardt Limited has plans to expand its bulk drug unit at Bharuch in Ankleshwar and Ranbaxy Laboratories Ltd is planning to set up a bulk drug plant at Lalru in Patiala district of Punjab.
The other applications include Vijaya Lakshmi Drugs and Chemicals' unit at Ranga Reddy in AP, Legend Industries's unit at Ahmedabad, Amishi Drugs and Chemicals Ltd.'s unit at Chacharwadi near Ahmedabad, Chennai based drug maker Apex Laboratories Ltd's unit at Ankleshwar, Dharuhera Pharmaceuticals Pvt. Ltd.'s unit at Dharampura in Rewari, expansion of bulk drug unit by Apotex Pharmachem India Pvt. Ltd. at Bangalore, Pharma Base India Pvt. Ltd.'s new unit at Ambernath near Thane, Elixir Chemicals Pvt. Ltd.'s new unit at Tarapur in Thane, Sohan Healthcare Pvt. Ltd's unit at Kurkumbh near Pune, expansion of the existing plant by Nectar Life Sciences Ltd. at Patiala in Punjab and DSM Anti Infective India Ltd.'s plans to expand its unit at Nawanshar etc.
With sales of $2bn in 2005, the Indian API manufacturing industry is the third largest in the world and is expected to make sales of $4.8bn by 2010, with an average yearly growth rate of 19.3 per cent, according to some estimates. As per a recent Chemical Pharmaceutical Generic Association (CPA) analysis, India is well positioned, thanks to low labour and environmental costs, the size and dynamism of its economy and incentives provided by the Indian government, may in the long term threaten the dominance of China as top API producer.