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Cadila Pharma wins ‘Observe Now Future of Workplace Award’
Ahmedabad: Cadila Pharmaceuticals was awarded a ‘ObserveNow Future of Workplace Award’ and a certificate of recognition at a glittering ceremony at Noida on Wednesday, September 11, in the presence of 50+ Chief Human Resources Officers and HR Heads from various organizations. Cadila Pharmaceuticals and its HR leader was selected by the esteemed jury members as one of the winners of the ObserveNow Future of Workplace series. The awardees were finalized after a rigorous selection process. “The selection was made on the basis of the technologies used in the company, HR policies, and initiatives taken to make the organization an employee friendly futuristic workplace,” Cadila Pharmaceuticals said in a release.

 


 
Pharma Wants A Booster Fund to Push Innovation
Ahmedabad, Mumbai: The Indian Pharmaceutical Alliance, a group of top research-based pharmaceutical companies, has urged policy think tank Niti Aayog and the Department of Pharmaceuticals to set up a large fund to boost technological innovation in pharma and healthcare startups. “We have approached the government to set up dedicated funds to boost innovation and startups in the pharma space in India,” said Sudarshan Jain, secretary-general, IPA. Last month, the IPA submitted its Vision 2030 document that highlights opportunities and challenges in the Indian pharma sector. The document seeks to promote innovation backed by risk capital to further boost pharma and health technology innovation in India. “IPA is advocating and advising the government to set up a startup VC fund to boost innovation in pharma,” said Pankaj Patel, CMD of Cadila HealthcareNSE 1.20 %, one of the top five pharma companies in India in terms of revenue. Patel, who is also former IPA president, said the sector has to innovate to grow faster.

 


 
Pharma Body Wants Certainty, Predictability in Price-Control Mechanism
New Delhi: While the pharma industry supports the government’s initiatives to offer medicines at affordable prices, it wants certainty and predictability in the price control mechanism, the Organisation of Pharmaceutical Producers of India (OPPI) has said. The industry body said it aims to make sure that innovative drugs that are available in the rest of the world are made available in India as soon possible. “The certainty and predictability of price control mechanism is very important for us. What we want is clarity and stable policies so that we can plan and anticipate in advance,” OPPI President and Glaxo SmithKline Pharmaceuticals MD India & Vice-President South Asia A Vaidheesh told PTI. OPPI is not against any of the government initiatives to give medicines at affordable prices to the people, he said. “As a body we also want to understand how to provide medicines at affordable price through healthcare financing mechanism,” Vaidheesh said. He further said the industry is evaluating how to participate in Ayushman Bharat to make sure that common people gets access to the latest products through financing schemes. “We also want that drugs that are already very cheap should not be in the price control mechanism,” Vaidheesh said. He pointed out that it is essential to maintain the quality of generic medicines.

 


 
Indoor Air Pollutants Can Decrease the IVF Success Rate
Bengaluru: Air quality in healthcare facilities is crucial, especially in critical areas like OT, ICUs, NICUs and IVF labs. Air quality in IVF labs can have significant effects on embryo development. IVF laboratories demand technical and operational requirements to maintain clean air. AAF (American Air Filter), a Daikin group company, the world’s largest clean air solution provider recommends employing a high-efficiency air filtration system to limit airborne contaminants in IVF labs. With the combination of particulate air filter and chemical filters, airborne particulates and VOCs (Volatile Organic Compound) can be effectively removed in IVF labs. According to a recent study, ART lab design and construction of the HVAC system and operational practices play a vital role, in optimizing air quality to minimize physicochemical risks to the embryo. Unlike outdoor pollutants, indoor pollutants like micro-organisms (bacteria, fungi and viruses) and VOCs are harmful to IVF processes and embryo development. VOCs are gases released from the materials used in laboratory construction and finishing (flooring, adhesives, paints, sealants, etc.). These VOCs may react with the lab conditions, resulting in poor IVF outcomes. VOCs can be efficiently removed by adopting a suitable chemically impregnated carbon filter. Also, micro-organisms can attach themselves to airborne particles such as skin cells, hair, clothing fibers. Hence, the implementation of particulate air filter and carbon-activated filters known as chemical filters should be an integral part of IVF cleanrooms. AAF recommends adopting the highest hygiene standards in critical laboratories and centralized built-in air filtration systems with particulate and chemical filters. Customized air filtration solutions could give healthcare facilities a significant benefit to maintain optimum environmental conditions in achieving successful treatments.

 


 
Alembic Pharma Gets USFDA Tentative Approval for Bimatoprost Ophthalmic Solution, 0.01%

Alembic Pharmaceuticals Limited announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bimatoprost Ophthalmic Solution, 0.01%. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), LUMIGAN ophthalmic solution 0.01%, of Allergan Inc. Bimatoprost Ophthalmic Solution, 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost Ophthalmic Solution, 0.01% has an estimated market size of $704mn for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 100 ANDA approvals (88 final approvals and 12 tentative approvals) from USFDA. The current market cap of the company is Rs 9,989.56cr.

 


 
Glenmark Receives Regulatory Nod to Market Combination Drug for Diabetes in India
New Delhi: Glenmark Pharmaceuticals on Monday said it has received regulatory approval to market a combination of Remogliflozin etabonate and Metformin hydrochloride film-coated tablets in India. The drug is indicated for treatment of type-2 diabetes mellitus in adults, Glenmark said in a statement. The approved dosage strengths are 100 mg of Remogliflozin combined with either 500 mg or 1,000 mg of Metformin, it added. "The approval for Remogliflozin and Metformin combination is a testament of our commitment towards revolutionizing diabetes management in India," Glenmark Pharma President India Formulations, Middle East and Africa Sujesh Vasudevan said. This combination is indicated as an adjunct to diet and exercise to improve glycemic control in type-2 diabetes mellitus patients, the statement said. The company will commercialise the product under the brand names 'Remo-M' and 'Remozen-M', it added.

 


 
Unichem Gets USFDA Approval for High Blood Pressure Drug Chlorthalidone
New Delhi: Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure. The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Chlorthalidone tablets USP in the strengths of 25 mg and 50 mg, Unichem Laboratories said in a regulatory filing. The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC. Hygroton tablets is indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension, Unichem Laboratories said. It is also used as an adjunctive therapy in edema, associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy and the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Unichem said the product will be commercialised from its Ghaziabad plant..

 


 
Dr. Reddy's Launches Roche's Avastin Biosimilar in India
New Delhi: Drug firm Dr Reddy's Laboratories on Monday said it has launched a biosimilar of Roche's Avastin in India indicated for the treatment of various types of cancers. The company's biosimilar, Versavo, is available in strengths of 100 mg and 400 mg single use vials, Dr Reddy's said in a statement. Commenting on the launch, Dr Reddy's India and Emerging Markets CEO M V Ramana said: "We regard the good health of our patients as our responsibility and are committed to ensure that they always have access to the medicines they need".

 


 

Shivani Scientific Industries Wins a Historical Case That Classifies ICSI Machines Used in IVF Procedures as Medical Devices
Mumbai: Shivani Scientific Industries Pvt. Ltd., a Mumbai based IVF and ICSI technology provider, has won a litigation that now allows classification of ICSI machines, used in IVF and, as medical equipment. The verdict will help reduce the IGST(Integrated Goods and Service Tax) levied on the machines, and the resultant benefits can be passed over to patients, making the IVF and Male infertility treatment cheaper and affordable. The landmark verdict of the litigation fought and won by Shivani Scientific Industries, is helping bridge this challenge. Shivani Scientific Industries was able to prove the modern usage and significance of Micromanipulator with Microscope, active components of the ICSI machine, as vital medical devices in treatment related to male infertility and was granted a favourable verdict.

 


 
Practo Online Consult Witnesses 88% Growth in Mental Health Queries
According to World Health Organization, one person dies every 40 seconds because of some form of mental disorder and only 10% of patients suffering from mental illness receive treatment in India. Still considered a taboo subject, mental illness is often swept under the carpet and patients who suffer from mental disorders are leading poor quality life in India. In a country like ours, the stigmas attached to mental health and societal pressure has led to hesitancy in seeking timely medical assistance. In light of such statistics, Practo has been striving hard to bridge the gap between the need for medical assistance for mental health and accessibility to the right healthcare professionals in India through technology. Practo’s Online Consult has registered an 88% growth in psychiatric queries since last year. Consumers have increasingly preferred online consultation as it helps in understanding the symptoms via virtual assistance at the initial stage and removes all apprehensions of visiting a doctor for further treatment. Online consult also aids in getting immediate answers to some burning questions about anxiety, depression and more from Medical Council registered quality doctors. Solving for accessibility issue, Practo’s Online Consult is not just helping people from metro cities but also patients from tier 2+ cities and rural areas where the availability of mental health professionals is very limited.

 


 
PET Bottles do Not Leach Cancerous Chemicals: CSIR
Mumbai: Water stored in PET bottles does not cause endocrine disruption, the Council of Scientific & Industrial Research (CSIR) has said in a study. Simply put, the study says that PET does not affect a person’s hormone-secreting glands, which means it is not cancerous. CSIR made its report on PET, or polyethylene terephthalate, based on a comprehensive study on male and female rats. The study was on whether water in PET bottles or food in PET packaging get contaminated with toxic substances like heavy metals (ie, lead and mercury) and phthalates (a chemical found in many plastics). “All specific migrations of such substances into simulants (all types of acidic, alkaline or fatty foods) were found to be not only below their permissible limits, but were found to be even below their detection limits,” the summary of the study report stated. “The equipment used for the study (NMR, or nuclear magnetic resonance, and ELISA, or enzyme-linked immunosorbent assay) are capable of showing the presence of molecules at the minutest levels (units per billion),” said an official. PET Packaging Association for Clean Environment (PACE) approached CSIR in June 2016 for an examination of PET packaging. “Considering the expertise available with CSIR and our constituent Central Food Technological Research Institute (CFTRI), we readily accepted the challenge,” said a senior official from CSIR-CFTRI, Mysuru, in his preface to the study report. According to another senior official from CSIR, the findings are more relevant than standalone tests and would set food packaging quality benchmarks.

 


 
Government to Come Up With List of Over-The-Counter Drugs Soon
New Delhi: The government is set to come up with a list of over-the-counter (OTC) medicines under a separate schedule by making changes in the drug law with stringent regulations on quality, advertisement and pricing of such products. “The move is aimed at promoting self-care and reducing the cost of treatment without compromising patient safety. It will also help us ensure that ‘prescription-only’ drugs are not misused, while other commonly used medicines which are not toxic are easily available to patients,” a senior official told TOI. The decision to have separate provision for OTC under the Drugs and Cosmetics Act was taken in a meeting of the Drugs Consultative Committee (DCC) under the health ministry last month. DCC’s decision is based on recommendations of a sub-committee formed earlier to examine the issue. “The sub-committee is of the opinion that there is an urgent need for defining OTC drugs and to lay down specific provisions for the regulation of OTC drugs in the country,” the DCC noted in its minutes of the meeting. The DCC has directed the sub-committee to identify such list of OTC products along with conditions and frame draft for amendments in the law. At present, there is no definition of OTC medicines and therefore, any medicine that is not a ‘prescription-only’ product, automatically qualifies as OTC. Pharmacists are free to sell such products on their own and patients can buy them without any medical advice or consultation. Commonly used analgesics like paracetamol and ibuprofen and medicines for cough, cold and flu fall under the OTC category. Apart from the advertisement norms and definition, the proposed changes will include basic characteristics of OTC drugs and their classification into OTC-1 and OTC-2 based on safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, supply chain mechanism and socio-economic conditions of the country. It will also define criteria and conditions for any medicine to switch from prescription drugs to OTC category as well as regulation for new OTC drug approval, distribution & sale. Such OTC products can also be advertised, whereas advertisement of prescription drugs is prohibited under the law. “In the absence of a clear definition and legal recognition to OTC products, it is difficult to regulate them. On one hand, these are pharmaceutical products or medicines and hence fall under the drug law. However, since many of them are not listed under Schedule H and X – which are for ‘prescription-only’ products – they circumvent the regulation,” an official said. Companies often also tweak commonly used formulations to bring their popular products out of the prescription-only list and then sell such products as OTC under similar sounding brands. This also helps them circumvent price control at times as the changed combination is unlikely to be part of the price controlled National List of Essential Medicines (NLEM). Similarly, newly launched products are often not part of the Schedule H and X, and companies or chemists are free to sell them as OTC without prescription till the time they are brought under the provisions of the law. The government and the regulator are also concerned about chemists pushing some high-end antibiotics as OTC products, causing potential risk of antimicrobial resistance.

 


 
Mobile App Launched for Locating Outlets and Searching Generic Medicines

Union Minister for Chemicals and Fertilizers, Shri D.V. Sadananda Gowda launched a mobile application “Janaushadhi Sugam” which will enable people to search Janaushadhi generic medicines and the stores at the tip of their fingers. Janaushadhi Sugam” mobile application would have user-friendly options like- to locate nearby Janaushadhi kendra, direction guidance for location of the Janaushadhikendra through Google Map, search Janaushadhi generic medicines, analyse product comparison of Generic vs Branded medicine in form of MRP & overall Savings, etc. The mobile application is available on both Android & iOS platforms. It can be downloaded free of cost by the user from Google Play Store and Apple Store. Along with that health ministry also announced that Jan Aushadhi Suvidha Oxo-Biodegradable Sanitary Napkin will now be available at only One Rupee per pad. The Minister of State Chemicals & Fertilizers, Shri Mansukh L. Mandaviya said that it is that about 28 million girls are reported to be leaving education because of lack of availability of good quality Sanitary Napkin pads at reasonable cost. He said, Department of Pharmaceuticals is determined to provide affordable healthcare to all Indians through ever-increasing network of PMBJP Kendras across country and this had already led to substantial savings to poor on medicines.

 


 
Bangladesh Pharma Exports Soar 26%
Dhaka: Bangladesh’s medicine exports soared 25.60 percent year-on-year to $130 million last fiscal year thanks to continuous improvement of product quality and government support. The sector has built up skilled manpower and improved quality and at the same time more effort is being put to win the global market, said Mizanur Rahman Sinha, managing director of ACME Laboratories. “For this reason, the export volume is increasing. The export figure though is insignificant. But the sector has a good potential in the global market,” he added. Local players dominate Bangladesh’s pharmaceutical industry. Square Pharmaceuticals is the major player with 18.8 percent share, followed by Incepta at 10.2 percent, Beximco 8.5 percent, Opsonin 5.6 percent, Renata 5.1 percent and Eskayef 4.5 percent, according to the Bangladesh Association of Pharmaceuticals Industries (BAPI). Multinational companies Sanofi and Novo Nordisk also have significant presence with their specialised products. According to BAPI, Bangladesh exports pharma products to 144 countries and caters to 97 percent of the domestic market. In 2017, the per capita consumption of medicine in Bangladesh was about $15.36. “Foreign buyers are coming in continuously and visiting our factories to examine the quality of products. More often than not they are placing orders,” Sinha said. Bangladesh mainly exports medicine to Africa and Asia, with some even going to the US and Europe, said Shafiqul Islam, vice-chairman of the Export Promotion Bureau. “I believe within the next 5 to 10 years, our pharma products will enter the US and EU properly and for this reason EPB is helping the sector.” Local consumption of medicine is increasing in line with the rise in population and growing awareness on treatment, he said. Currently, Bangladesh has the ability to produce advanced medicines such as bio-similar drugs, vaccines and oncology products as well as medical devices, said Mohammad Ebadul Karim, managing director of Beacon Pharmaceuticals. “We do export oncology products to Sri Lanka, Nepal, Myanmar, Singapore, Malaysia and African countries. But volume is still low -- we should to grab the regulated market to increase the volume,” he added. According to his estimates the market size of the sector is about Tk 22,000 crore. In 2012, the local market size stood at about Tk 9,390. In 2017, it stood at Tk 18,755.6 crore, according to IMS Health Care Report. Karim also emphasised on upgrading technology and infrastructure to boost exports and enter regulated markets. In 2015, the US Food and Drug Administration gave approval to Square Pharmaceuticals and Beximco Pharmaceuticals after inspecting the oral solid dosage facilities of the two companies. Bangladesh has made commendable progress in pharma sector over the years through policy support from the government, skilled workforce, cost competitiveness, modern infrastructure and cGMP compliance, said Rabbur Reza, chief operating officer at Beximco Pharmaceuticals. The export potential for differentiated products -- such as metered dose inhaler, dry powder inhaler, sterile ophthalmic, injectable -- is high in key emerging and developed markets due to less competition, he added.

 


 
Mark Beaudouin to Retire as Waters General Counsel; Company Promotes Keeley Aleman
MILFORD, Mass.--(BUSINESS WIRE): Waters Corporation (NYSE: WAT) recently announced Mark T. Beaudouin is retiring as Senior Vice President, General Counsel and Corporate Secretary after 16 years leading the Company’s legal team. Current Vice President, Deputy General Counsel and Assistant Secretary, Keeley A. Aleman, will be promoted to Senior Vice President, General Counsel and Corporate Secretary, and a member of the Executive Committee, effective October 1, 2019. Mr. Beaudouin will remain with the company in an advisory role prior to retiring at the end of the year. “On behalf of the board of directors and all Waters employees, I want to personally thank Mark for his immeasurable contributions to Waters’ success over the course of his distinguished career” “On behalf of the board of directors and all Waters employees, I want to personally thank Mark for his immeasurable contributions to Waters’ success over the course of his distinguished career,” said Christopher J. O'Connell, Waters Corporation Chairman and CEO. "Mark has been a trusted, forward-looking advisor to the company throughout his tenure. We wish him all the best in his retirement.” In his time with Waters, Mr. Beaudouin has been instrumental in the Company’s globalization initiatives, governance structure, counseling of Board of Directors and its committees, as well as creation of regulatory and government affairs functions. Mr. Beaudouin was recognized by Massachusetts Lawyer’s Weekly as a “Leader in the Law” in 2011, and honored by the New England Legal Foundation with the John G.L. Cabot award in 2018. Mr. O'Connell added, "I am looking forward to working with Keeley as our next General Counsel. She is a highly talented, experienced and trusted lawyer and leader within Waters. Keeley’s promotion is a reflection of our robust talent development program and succession plan, and her leadership will enable our legal function to continue executing at the highest level. She will be a great addition to the Executive Committee, and will be a trusted advisor to me and our Board of Directors.” Since joining Waters in 2006 as the Assistant General Counsel, Ms. Aleman has held legal roles of increasing responsibilities and focused on business transactions, commercial strategies, international development, compliance, corporate governance and organizational matters. Additionally, she has been an inspirational leader as co-chair of Waters Gender Diversity Network, the company’s first formal diversity engagement initiative fostering a balanced workforce in a supportive environment. Prior to joining Waters, she held corporate associate positions at Goodwin Procter, LLP, and Testa, Hurwitz & Thibeault, LLP. Ms. Aleman holds a Juris Doctorate degree from Boston University School of Law, magna cum laude, and a Bachelor of Arts degree with honors from the University of California at Davis.

 


 
First Vaccine to Protect Against Ebola
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus. “This is an important step towards relieving the burden of this deadly disease,” said Guido Rasi, EMA’s Executive Director. “The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola. Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives.” Ebola virus disease is a rare but severe illness caused by the Ebola virus. Death rates in patients who have contracted the disease have varied from 25% to 90% in past outbreaks. The largest outbreak to date occurred in West Africa in 2014-2016 with more than 11,000 deaths. The current outbreak in the Democratic Republic of Congo (DRC) which is caused by Ebola Zaire, has shown case fatality rates of approximately 67%. More than 3,000 people have been infected with the Ebola virus during the ongoing outbreak, which was declared a public health emergency of international concern by the World Health Organization (WHO) in July 2019.

 


 
First Non-Injectable Treatment for Severe Low Blood Sugar Levels
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Baqsimi (glucagon), the first treatment for severe hypoglycaemia (low blood sugar levels) that can be administered without an injection to patients with diabetes aged four years and older. Severe hypoglycaemia is a serious acute complication of diabetes. It occurs when the level of sugar in the blood drops to a level where the patient becomes confused or unconscious and requires assistance from another person to administer a medicine. If left untreated, severe hypoglycaemia can lead to serious consequences, including seizures, coma, adverse cardiovascular outcomes and even death. Glucagon increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream. It has the opposite effect of insulin, which lowers blood sugar levels. Injectable glucagon is currently the only treatment option for extremely low levels of blood sugar outside of a hospital or emergency medical setting. Its use often requires training as it has to be prepared in several steps before it can be administered to the patient by either subcutaneous or intramuscular injection. Baqsimi provides a novel pharmaceutical formulation of glucagon. The medicine comes in a single-use dispenser which is ready to use and can be administered through the nose by caregivers. Patients do not need to inhale or breathe deeply after dosing, enabling drug delivery even in unconscious patients.

 


 
CPhI Pharmaceutical Machinery Report: ‘Critical Time to Invest in Machinery with Changing Drugs Pipeline’
Amsterdam: Ahead of P-MEC 2019, the only dedicated pharmaceutical machinery event in Europe this year – co-located with CPhI Worldwide in Frankfurt, 5-7 November – the first ever CPhI Pharmaceutical Machinery Report identifies trends impacting the market. The findings highlight how the changing drugs pipeline and the industry’s drive towards more efficient manufacturing is necessitating new investments in pharma equipment. The evolving R&D pipeline of smaller volume drugs, coupled with advanced technologies that remove scale-up challenges – such as single-use equipment and continuous processing – are not only transforming industry attrition rates, but vastly changing the types of machinery used in pharma manufacturing. Moreover, running alongside this pipeline evolution are newer approaches that reduce the number of steps in process development, making production greener and lowering overall cost. Manufacturing is now at a crucial juncture as push and pull drivers – including newer technologies, changing pipelines and demand for lower cost drugs – combine to significantly alter how drugs will be made in the future. The report predicts we are on the cusp of a new age of smart pharma manufacturing, as equipment is set to take centre-stage in the development of advanced medicines. P-MEC 2019 itself is testament to this trend. Exhibitor numbers have doubled in a single year to over 150, as the industry shifts its perspective on new technologies from ‘in an ideal world we would’ to ‘we must have these to grow’. In an industry that has often been dependent on legacy systems and undertaking manufacturing in ‘the same way as before’ for fear of encountering any potential regulatory hurdles, this is a seismic shift. Significantly, this potentially has huge implications for the entire supply chain and CPhI Worldwide – the largest pharma event in the world with more than 45,000 attendees – is seeing changes across all parts of the show from contract services to ingredients, packaging and finished dosage drugs. The report also forecasts how flexibility in product design is now integral to the lifespan of equipment – a consequence of new products often being produced for smaller patient cohorts. For example, new types of delivery systems and dosages, mean new packaging and labelling equipment are needed that can adjust to these individual dosage forms. Reflecting industry drivers, the agenda at P-MEC 2019 explores the implications of patient centricity, evolving equipment for an eco-friendly age, and how new devices used in the biologics industry are affecting equipment considerations and the implications for filling machines. In another key trend, regulators are striving to make manufacturing processes increasingly standardized and controlled – with technologies that improve quality risk-based methodologies (QRM), Quality by Design (QbD), process analytical technology (PAT) and continuous manufacturing encouraged. A potential implication of seeking greater control in process methods will be the need for an increased use of real-time monitoring. Significantly, methods from raman and infrared spectroscopy, chromatographic separation to faster technologies such as ultra-performance liquid chromatography (UPLC) or ultra-high performance LC (UHPLC) are proliferating alongside nuclear magnetic resonance (NMR). However, the big challenge that continues to remain is how to build these into commercial production for real-time analysis in enclosed systems, single use technologies, and continuous rigs. Finally, the report ponders how digital technologies may improve production and machinery as an ‘unknown variable’. For example, the impact that digital technologies will play in reducing downtime and increasing process efficiency through AI. One solution could see the use of connected machines to reduce the need for pharma customers to audit contract manufacturers or ingredient suppliers in person – with real-time product updates supplied automatically, essentially a natural evolution of PAT guidelines. Orhan Caglayan, Brand Director - CPhI Worldwide & P-MEC, said: “From the optimization of old legacy manufacturing sites to the increased use of testing facilities and equipment, there is genuine excitement around the pharmaceutical machinery industry. This is mirrored by a 50% increase in exhibitors at this year’s P-MEC event, with over 150 confirmed exhibitors so far. What’s more, P-MEC is taking place in Frankfurt, Germany – a hub of manufacturing and Europe’s largest pharma market – and it’s the only pharmaceutical machinery exhibition this year in Europe. So it’s an unmissable opportunity for any company looking to explore the latest technologies to transform the way they work both today and in the future.”

 

  

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