Hyderabad - Biotech & Pharmaceutical Hub Updates

[kailash9999]

Originally Posted by Prodigist

Hyderabad hailed as pharma capital in UN report on cities


Source: The Asian Age

+infinity !!!

[kailash9999]

India Gets Its Biggest Isotope Labelling Unit

Source: Med India, Author: Bidita Debnath, Dated: November 24, 2012 at 3:42 PM



Asia's leading drug discovery research and development organisation, GVK Biosciences, has set up the largest isotope labelling facility in India.

Isotope labelling is a technique used to track the passage of an isotope, or an atom with a variation, through a reaction.

The Hyderabad-based company has also received approvals from the Atomic Energy Regulatory Board (AERB) to carry out 3H and 14C synthesis activities.

> This Good Laboratory Practice (GLP) compliant facility has state-of-the-art equipment to meet the requirements of companies engaged in the fields of drug discovery and development, agro and veterinary chemicals, cosmetics, perfumery and specialty studies, said a company statement here Monday.

"Several of our customers requested us to extend our chemistry services to include isotope labelling services. We listened to our customers and set up this state-of-the art facility, the largest such facility in India," said Manni Kantipudi, CEO, GVK BIO.

GVK BIO's diverse portfolio of nearly 200 customers includes some of the world's largest pharmaceutical, biotechnology, agro, life-sciences companies and leading academic and research institutions.

Source-IANS

[Gudavalli]

AP to focus on building pharmacy as most preferred professional educational brand

With a view to attract more students to take up pharmacy education as a serious profession, the 51st National Pharmacy Week celebrations that was conducted recently in Andhra Pradesh focused on building pharmacy as the most preferred professional educational brand in the state.

The event that was jointly organised by the Indian Pharmacy Graduates' Association (IPGA), in association with All India Drugs Control Officers' Confederation (AIDCOC), the Indian Pharmaceutical Association (IPA), Pharmaceutical Export Promotion Council of India (Pharmexcil) and Organisation of Pharmaceutical Manufacturers (OPM) at NIPER, Hyderabad, focused on the importance of pharmacists in public health and role of pharmacists as community pharmacists.

Experts from the industry pointed out that though pharmacy courses like B. Pharm and M. Pharm provide a wide scope of job opportunities and career growth, these professional courses have not yet been able to acquire the intended brand recognition among the students, because of which the pharmacy as a profession is regarded as the third in line profession after medicine and engineering. They point out that pharmacy education in the state is seriously lagging behind to attract the top meritorious students into its fold; this in turn is impacting on the future growth prospects. Lack of innovative thinking and unavailability of efficient human resources are clear reflections of declining research and development in the field of pharmacy.

Kondru Murali Mohan, minister for medical education and health and family welfare AP, while addressing the event assured to extend all the possible support to the pharma professionals and industry in the state. He urged the young graduates of pharmacy to take up job in the community retail pharmacy profession and help the needy patients by counselling regularly. He also requested the pharma educational institutions to impart all the best expertise and knowledge to the budding pharmacists so as to make them employable in the industry.

G Dharma Data, president, IPGA, and Dr B Prabha Shankar, honorary secretary, IPGA stressed on creating more awareness among the public about the role of pharmacist in the healthcare management and even urged them to organise campus recruitment drives in colleges to help young pharmacists get job within the industry. To which the industry argued that even pharmacy colleges should also take steps to prepare their training programme in consultation with the industry to match it with the changing trend so that they can be easy absorbed accordingly. They pointed out that today there is a huge shortage of pharmacists in the retail pharmacies and marketing segment.

Dr M Venkata Reddy, former director of Andhra Pradesh Drug Control Administration was awarded with the IPGA NATCO eminent pharmacy graduate award during this event for his huge contribution in the pharmcy field.

[Gudavalli]

PCB all set to lift ban on 11 bulk drug makers

HYDERABAD: Despite stiff opposition from environmentalists, 11 major bulk drug manufacturing units in the city are likely to be 'freed' from the 15-year-old ban on expansion in the Patancheru-Bollaram industrial belt. And it's all thanks to the chairman of the state Pollution Control Board (PCB), Janaki Kondapi, says officials from within the department who do not wish to be named.

The PCB chief known for being 'industry-friendly' is pushing to drop the ban even as other senior officials of the board, including member secretary M Ravi Chandra, is said to be in disagreement with their boss, highly-placed sources said.

In fact, sources said that Kondapi is currently faced with severe criticism for recommending lifting of the ban, which they believe will spell doom for the already polluted pocket of the city. "Even in the past, she (Kondapi) has issued similar objectionable orders and sanctioned industries in mangrove-thick zones. Even then, she had met with serious opposition from not just environmentalists but also government officials," said a source. While Kondapi's pursuance may come as a huge relief for pharma biggies, who are looking at expansion of their plants, but it would spell disaster for ecology and environment in the state, activists told TOI.

The Patancheru-Bollaram zone has been previously declared as one of the 24 "most critically polluted areas" of India by the Central Pollution Control Board. It is for this reason that the Supreme Court too, in 1998, seconded the ban that has been in place ever since. "But the current board of the PCB is unfortunately very industry-friendly. They do not want to upset the big firms who have been pestering the board to lift the ban for quite some time now," said the source.

The latest PCB board meeting was held on December 4. It was during this meet that the lifting of the ban was discussed and a letter subsequently forwarded to the state government. A technical report drawn up by a group of senior scientists giving a clean chit to the industries, has also been attached with the letter, sources added.

At present, the matter is awaiting clearance from legal experts working for the state government. "Even if the ban is lifted, it will only hold good for a few drug manufacturing units. Those promising zero liquid discharge and with international affiliations alone will be exempted from the ban," said a senior officer of the state government, clearly indicating that the move is being made to benefit major players. "Smaller units with no facility to treat its effluents or new units coming up in the area will not be excused," he said.

Such disparities clearly fail to amuse either environmentalists or those concerned about the 'health' of the choking industrial belt. "It is the major units that are in fact killing the environment. The zero liquid discharge is nothing but a farce. Many of them have been caught red-handed in the past too. Even then if the government favours them, it's shameful," a PCB insider said.

It was only four months ago that 12 units belonging to Aurobindo Pharma Ltd, Hetero Drugs Ltd, Krishna Pharmaceuticals Ltd, among others were slapped with closure notices for violating PCB's environmental norms. The PCB chief was not available for a comment and several attempts to reach her failed.

[Gudavalli]

World pharma trade centre planned at Hyderabad

Andhra Pradesh industry minister J Geeta Reddy on Saturday said the state government was actively working on establishing a world pharmaceutical trade centre in Hyderabad, an important hub for pharmaceutical companies in the country.

The move was aimed at business development in the domestic pharmaceutical sector as a dedicated global trade centre would provide further impetus for local industry to grow through buyer-seller meets. Global companies would also come to establish their facilities including in areas of drug discovery, she said.

The proposed trade centre is likely to be located at Rayadurg near the city's IT hub and the foundation stone is expected to be laid in March, according to the minister.
In another development, the Government of India has agreed to include some parts of Andhra that are closer to Tamil Nadu and Bangalore into the proposed Chennai-Bangalore industrial corridor, according to the minister.

About 73 industrial projects with an investment of Rs 1.2 lakh crore are under implementation while 10 industrial units with a total investment of Rs 3,126 crore have started operations, she said, explaining the status of the MoUs signed during the investment summit held in January this year.

[amby_1986]

About the bengaluru ---chennai industrial corridor ...they have to include AP or else most of the corridor would be in tamil nadu ............
I think three states should be equally beneficial .....not one state garnerning largest share ....

[Gudavalli]

Aurobindo gets final approval for Abacavir tablets

Aurobindo Pharma has received final approval from the US Food and Drug Administration (FDA) to manufacture and market the earlier tentatively approved abacavir tablets USP 300 mg. Abacavir tablets is the generic equivalent of ViiV Healthcare Company's Ziagen tablets 300 mg and is is indicated as part of antiretroviral (ARV) combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children. The annual sales o the product is approximately US$ 88 million.

The product has been approved out of Unit III formulations facility in Hyderabad. Aurobindo now has a total 167 ANDA approvals (141 final approvals including two from Aurolife Pharma LLC and 26 tentative approvals) from US FDA.

[Gudavalli]

Aurobindo wins FDA nod for generic anti-HIV drug

Aurobindo Pharma has won the final FDA approval to manufacture and market its generic anti-Human Immunodeficiency Virus (HIV) drug, Abacavir Tablets USP 300mg.

Abacavir, the generic version of ViiV Healthcare Company's Ziagen Tablets 300mg, is used to treat HIV infected adults and children as a part of antiretroviral (ARV) combination therapy.

The product that has been approved out of its Hyderabad Unit III formulations facility is ready for launch, according to the company.

Each Ziagen tablet contains abacavir sulfate equivalent to 300mg of abacavir as active ingredient in addition to inactive ingredients such as colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

[Gudavalli]

Thrust on capacity building of drug testing facilities during 12th Plan: Azad

The Government is planning large scale capacity building of drug testing in the country during the 12th Plan including upgradation of existing labs, setting up of new labs, setting up of mini labs at ports of entry, commissioning of mobile labs, special labs for medical devices and cosmetics.

Disclosing this in the Parliament recently, Union Health Minister Ghulam Nabi Azad said the Government has given special attention to strengthening and upgrading the infrastructure of States drug regulatory system which plays major role in enforcement of provisions of the Drugs & Cosmetics (D&C) Act and hence in checking the problem of spurious drugs.

“A new Centrally Sponsored Scheme to help them during the 12th Five Year Plan has already been envisaged. The scheme includes strengthening of both the physical infrastructure and human resources. A new budget line has been opened and an initial token provision of Rs.2 crores has been made in 2012-13 budget,” he said.

Referring to the spurious drugs, he said the media and some organisations were been projecting the problem of spurious drugs in the country in a manner which does not provide a balanced perspective and has, therefore, caused serious apprehensions. “These are unsubstantiated reports. For example, on the basis of an alleged WHO report, the media frequently reports that 35 per cent of fake drugs produced in the world come from India. However, when enquired, the WHO has denied its authenticity. A survey conducted by the Government in 2009 to assess the extent of spurious drugs revealed that the extent of drugs found spurious was 0.046 per cent only. ASSOCHAM’s report is not based on substantiated facts. The Government has taken a number of measures to check the problem of spurious and adulterated drugs in the country in the past in this regard and is also active in this direction,” he said.

Two Sub-zones of CDSCO (Hyderabad and Ahmedabad) have been upgraded to full zones and three new sub-zones (Bangalore, Chandigarh and Jammu) have been created to effectively cover the entire country under the active supervision of the CDSCO. The Central Drugs Testing Laboratories have been strengthened with new sophisticated testing equipments. A new laboratory at Hyderabad has been constructed, he said, while listing out the steps taken by the Government.

“The scheme of regular overseas Inspection of manufacturing facilities situated abroad has been initiated to ensure proper compliance of manufacturing facilities before registering them for Import of Drugs from overseas. Two such inspections in China have already been completed,” he said.

[rockystone]

MSN labs to invest Rs.150 cr for API, formulations & CRAMS unit in Hyderabad

MSN Laboratories Ltd, a fast growing active pharmaceutical ingredients and formulations company of India is planning to invest Rs.150 crore for setting up an API, formulations and CRAMS (Contract Research and Manufacturing Services) unit in Hyderabad.

Started small with a single unit in the year 2003, today the Hyderabad based MSN Labs has established 8 units across India of which 6 are manufacturing units catering to APIs, 1 unit for formulations and 1 research and development centre. Out of the 6 manufacturing units 3 units are US FDA certified while the remaining 3 are catering to ROW (Rest of the World) and Indian markets.

While sharing his views with Pharmabiz, MSN Reddy, CMD of MSN group of companies, revealed his expansion plans and said that the MSN group is planning to invest a total of Rs.150 crore in the first phase to set up an exclusive API, Formulations and CRAMS unit in Hyderabad. “We are a vertically integrated company and our main focus is global markets. At present we are growing consistently with a year-on-year growth of 30-40 per cent. Our major strength is our people and a focused R&D system,” said Reddy.

The year 2012 was a great year for the MSN Labs. The company achieved a growth target of 40 per cent. The overall turnover of the company by March 2012 was set at Rs.600 crore and by the end of the financial year march 2013 it is expected that the company will cross Rs.1000 crore. So far the company has filed 148 Drug Master Files (DMFs) globally of which 74 DMFs are filed in USA and other 74 are filed in EU.

Airing his future plans MSN Reddy said, “We are planning to launch 2 important molecules in EU and USA by 2015. Our research is mainly focused on the development of molecular base and not on therapeutics. At present we are having 3-4 potential molecules which can give us a competitive advantage and our success lies in winning new markets with new molecules.”

The MSN group of companies has been recognized globally and has been approved and certified by all countries as the quality and safety complier. Very soon the group is planning to develop a Green field facility for its formulations unit in a plot of over 40 acres in Hyderabad. The company is already having a patient portfolio of 150 drugs in different countries. It is also planning to file 35 more patients in USA and 40 patients in EU in the coming days.

[rockystone]

deleted

[Gudavalli]

GVK BIO enters into research collaboration with Endo Pharmaceuticals

HYDERABAD, INDIA — GVK Biosciences (GVK BIO), Asia’s leading drug discovery research and development CRO announced today that it has entered into a collaboration agreement with U.S. based Endo Pharmaceuticals focused on discovering novel small molecules targeting an exciting protein. Under this agreement GVK BIO will use its discovery expertise to deliver a clinical candidate and Endo will develop and commercialize the product arising out of this collaboration. This collaboration arose out of a newly launched concept at GVK BIO named Early Discovery Assets (EDA™).

Manni Kantipudi, CEO of GVK BIO commented, “We are delighted to partner with Endo as it continues to build its discovery pipeline through external collaborations. This collaboration also confirms the value of our differentiated EDATM concept, conceived to collaborate with pharmaceutical partners on discovery projects, from target to clinical candidates.”

Dr. Sandeep Gupta, Endo’s Senior Vice President of Drug Discovery and Early Development stated “We are pleased to initiate this discovery collaboration with GVK BIO. With their world class infrastructure and an experienced scientific team, I have no doubt that they will execute on the program goals and add to our portfolio of development candidates that provide novel treatment options for the patients”.

[Gudavalli]

Govt of AP and Gangwon Techno Park from South Korea sign MoU to share knowledge and technology

Government of Andhra Pradesh and Gangwon Techno Park from South Korea have signed a memorandum of understanding (MoU) to share knowledge and technology in the field of biotechnology on the second day of BioAsia being held in Hyderabad.

The MoU was inked between InKyo Kim, president of Gangwon Technopark and T Satyanarayana Rao, in-charge managing director of Andhra Pradesh Industrial Infrastructure Corporation (APIIC). Pradeep Chandra, principal secretary, Industry and Commerce, government of Andhra Pradesh was also present on the occasion witnessing the important agreement.

The main objective of the MoU is to exchange and share ‘know-how’ knowledge and information in field of biotechnology and related areas and to facilitate emerging companies and educational institutes to provide education and training which would further enhance co-operation and growth of business among the two states.

“The potential of biosimilar products is very high and if it can be tapped in the right direction the industry can reap to a tune of five to ten billion dollars in the coming days. The MoU will help in fine tuning the opportunities with technology and marketing facilities in the two Asian countries. The collaboration is beneficial to both the partners as they can engage together to explore optimum Biotech resources and products in the state,” said Pradeep, speaking on the occasion.

Andhra Pradesh has a well established biotechnology park at Genome Valley in Hyderabad and it has all the facilities available for the pharma and biotechnology companies engaged in research and development. InKyo Kim said that the objective was to take advantage of the resources and facilities being offered by the APIIC to promote biotech sector and enhance the contribution of their products by 30 per cent to the overall industrial GDP.

With this, overall BioAsia 2013 has witnessed two important MoUs signed, one is between Department of Biotechnology (DBT), government of India and Spain and the second one is between APIIC and Techno Park from south Korea.

[sriece19]

RS panel to visit Hyderabad, Mumbai to probe charges of prevalence of spurious drugs

Committee on Petitions of the Rajya Sabha will take fact-finding field visits and hold interactions with the stakeholders in Andhra Pradesh and Maharashtra, as part of a probe initiated based on a petition that sought steps to check on the manufacture of spurious drugs in the country.

The panel headed by Bhagat Singh Koshyari will visit Hyderabad on February 13 and 14 and then move to Mumbai for an on-the-spot study on February 15 and 16. The committee will visit manufacturing units, testing laboratories and hold meetings with the industry representatives.

At Hyderabad, the committee will visit the units in and around the city, besides holding interactions with various stakeholders including representatives of medical practitioners, drug manufacturers, association of pharmacies, apart from those from Departments of health and pharmaceuticals in the State.

Similar meetings and visits to the units will also be held in Mumbai. The Ministry of Health and Family Welfare has organized the visits to Indian Immunological Ltd, Dr Reddy’s Laboratories and Sipra Labs in Hyderabad. In Mumbai, the panel will visit Sandoz Pvt Ltd and Sitech Lab.

The visit is part of the probe initiated following a petition by one Rahul Gaur sometime back to the Committee, praying to put a check on manufacture of spurious drugs in the country and other related issues. He had pointed out that around 35 per cent of world’s spurious drugs were produced by India.

In his petition, Gaur has said that the manufacturers are free to produce any drug duly approved by the Drug Control Authority. But due to advancement of technology and relaxation in the norms by the government, the spurious drug industry is becoming well established in India. Quoting a WHO 2001 statistics, Gaur said that 35 per cent of the world's spurious drugs are produced in India, followed by Nigeria at 23 per cent. By all accounts the magnitude of this problem would have only increased in the last few years. It has been widely reported in the media that one out of five strips sold in North India is a spurious one.

The petitioner in his petition has demanded that the spread of use of spurious drugs in the Indian market should be controlled immediately through upgradation of appropriate laws. The recommendations of Dr Mashelkar Committee, specifically mentioning spurious drugs an offence under IPC and making the offence non- bailable and cognizable and recommending a maximum of death penalty for this offence, should be implemented.

[Gudavalli]

Vivimed Labs to acquire Finoso Pharma

The deal to cost around Rs 15 crore of cash, stock, deffered payment, to be debt free

Hyderabad-based Vivimed Labs Limited today said that it has proposed to acquire city-based Finoso Pharma Private Limited, a pharmaceutical development services company focused on formulations product development efforts for multiple markets and develops globally accepted dossiers.

The proposed acquisition will be done for a total consideration of Rs 15 crore comprising cash, stock and deferred payment, and will be debt free, according to a company press release.

With a state-of-the-art facility in Alexandria Techno Park in Hyderabd, Finoso had recorded a revenue and EBITDA of Rs 5.2 crore and Rs 1.6 crore respectively in the last financial year.

After acquisition, Finoso will become Vivimed’s research and development (R&D) unit to support innovators, generics and licensing efforts. RK Kumar, founder of Finoso, will enter into appropriate management contracts and employment agreements on completion of the transaction, the release said.

The company's scrip is currently trading at Rs 317.35 on BSE, down 3.34 per cent over the previous close of Rs 328.30.

[sandeeprai99]

The United States Pharmacopeia (USP), that formulates standards for the quality of medicines, food ingredients, and dietary supplements, has drawn up major expansion plans for Hyderabad development centre.
USP India Private Limited, which recently moved into a 1.2 lakh square feet office in Shameerpet, has also acquired a 5.5 acre plot of land adjacent to its existing office to set up a Centre for Biological Medicine and Centre for Chemical Medicine, sources said.
These two projects, which are slated to be completed in the next two-and-ahalf years, entail an investment of close to $30 million. While USP will be injecting $20m in the Centre for Biological Medicine, it would be investing $8million for the Centre for Chemical Medicine.
The Hyderabad centre is among USP’s five global sites and supports its international programmes to set public standards for medicine and food supplements. USP’s drug standards are followed in the United States by the US Food and Drug Administration and as well as regulators in 140 other countries. USP is also mulling creating a Herbal Medicine Compendium (HMC), on the lines of its Dietary Supplements Compendium (DSC), to help set standards for manufacturing and consumption of herbal products as well as traditional medicines and the Hyderabad centre will be playing a major role in this initiative.
When contacted, USP officials said, “We will soon launch the new Herbal Medicines Compendium (HMC) sometime this spring. The HMC is USP’s free, online resource that provides standards for herbal articles used in traditional medicines. Its purpose is to help ensure that herbal articles that qualify for inclusion in the compendium conform to the represented identity and are of good quality by providing up-to-date, relevant monographs with allied reference materials.” USP has already formed an expert panel in South Asia comprising mostly Indian experts that will review herbal medicine monographs for articles approved in India for inclusion in the HMC. An expert panel meet in this regard was held in January where delegates from countries such as China, Malaysia and other South Eastern countries along with domestic and international players participated to chart out the future course of action.
The HMC monographs will be available for adoption without charge or prior permission from USP by any interested party including manufacturers, suppliers, purchasers, national pharmacopeias and regulatory authorities, USP said.
The main idea behind the HMC is to boost public health by establishing the quality norms in herbal products and traditional medicines that can in turn help the manufacturers and the regulators to perform quality checks. Once the standard quality norms are established, it will also boost the prospects of the players that are into manufacturing of such products as it will open the doors of global markets.

[Prodigist]

Wonderful news.. Unfortunately Genome Valley is in a quaint little corner of the city for people to know it's significance. Not many people track the area in and around Turkapally but there are a lot of significant private biotech R&D centers around.

The only people who know about it are those who are in the pharma/biotech sector or those who visit Karimnagar.

Here's a list of the firms here.



These are Google Earth screenshots from 2003 and 2011. The difference is there for you to see
2003


2011

[Prodigist]

This place has been marked as Medtech Valley on wikimapia. It's huge and next to the ORR. I think they have created a layout and are constructing a few buildings(utility buildings) here.

There have been no investments by any private companies so far. It's an industrial park for manufacturing medical devices I think. Does anyone know more about this?

[sandeeprai99]

Genome Valley has witnessed an increase in investments of various leading global companies. With the availability of excellent support infrastructure and dynamics of the cluster, life science companies and labspace developers among others have committed/started development of their facilities in the cluster.

• Celon Labs, a fully integrated pharmaceutical company is developing its R&D campus in Genome Valley. The proposed development would help Celon Labs in strengthening its research & development activities.
• Indian Immunologicals, a leading biopharmaceutical company is developing a state-of-the-art R&D campus in a 50-acre land, with an investment of INR 100 crores

[sriece19]

SISA brings in advance shoulder surgery techniques to Hyderabad

Hyderabad based Sai Institute of Sports Injury & Arthroscopy (SISA) has brought in some of the advanced shoulder surgery techniques to Andhra Pradesh which may give a big relief to patients suffering from painful shoulder joint related problems in the state.

Three renowned shoulder surgery specialists, Dr Hannes Jonker from South Africa, Dr Raghuveer Reddy from SISA, Hyderabad and Dr Sachin Tapasvi from Pune demonstrated various advanced shoulder surgeries viz., Knotless Technology, Double row Technique and Reverse shoulder arthroplasty, which are all used to relieve patients from incapacitating and painful shoulder joint related problems.

Thanks to SISA for it has made available the much needed advanced technology and latest techniques in shoulder surgeries as this is going to give a big boost to serve especially patients from the sports and athletic community. The Knotless Technology, Double row technique & reverse shoulder arthroplasty are some of the most acclaimed latest shoulder surgeries techniques.

The ever increasing incidences of shoulder problems, in all age groups, have their origin in modern lifestyles. Due to the complex nature of the shoulder joint and lack of expertise in its management, patients were left to endure the pain and live with it. However, with SISA’s initiative it has given the much desired respite for all such silent sufferers by bringing in the most advanced techniques to Andhra Pradesh.

The new techniques now available for shoulder ailments, in the City at SISA, Shoulder Stabilisation Surgery with Knotless Technology is a technique used to repair repeated shoulder dislocations seen in young and those in productive age groups. This repair is done through an arthroscopy (key hole surgery). The technique permits speedy recovery and returning to their demanding work faster.

The Reverse shoulder arthroplasty technique addresses the irreparable rotator cuff tear with advanced stage shoulder arthritis in very elderly people. “Patients can now get their shoulder ailments rectified here in Hyderabad, by experts using the latest available techniques in shoulder joint management,” said Dr K Raghuveer Reddy, Shoulder & Knee Surgeon, SISA.