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Strategic sale of Hindustan Antibiotics, Bengal Chemicals Cleared
New Delhi: The Cabinet on Wednesday decided to close down State-owned Indian Drugs and Pharmaceutical Ltd (IDPL) and its subsidiary Rajasthan Drugs and Pharmaceuticals Ltd (RDPL) and put two others — Hindustan Antibiotics Ltd (HAL) and Bengal Chemicals and Pharmaceuticals Ltd (BCPL) — on strategic sale. “While the IDPL and RDPL will be closed and their land will be sold, strategic sale will be carried in HAL and BCPL,” said Information and Broadcasting Minister Prakash Javadekar. The sale and closure will be as per the revised guidelines of the Department of Public Enterprises and a Committee of Ministers will be constituted to take decisions relating to their closure/ strategic sale, including the sale of assets and clearance of outstanding liabilities. A sum of Rs. 330 crore from the funds raised would be spent on paying salary arrears and offering VRS to employees of these companies, he said. According to an official statement, these public sector units have more than 1,000 employees. While the funds required to compensate HAL employees are around Rs. 280 crore, IDPL and RDPL would need Rs. 6.5 crore and Rs. 43.7 crore respectively, the statement said. The decision assumes significance because the government has been trying to monetise the assets of these sick public sector pharma companies since December 2016, but could not do so. This was because workers in many of these units legally challenged the decision to sale the surplus land belonging to these firms to other government agencies. Even though the government issued tenders more than once, it could not get buyers for the same. Instead of strengthening these state-owned pharm companies, which have been supplying medicines at cheaper rates to government hospitals, the government wants to close them down to please private pharma companies, both domestic and foreign, said a trade union leader based in Delhi.

 


 
Zydus' Nesher Pharmaceuticals Receives USFDA Approval for ADHD Drug
Zydus' Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the USFDA to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate, Extended- Release Capsules (US RLD ADDERALL XR), 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 60 mg. The drug is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) which is a brain disorder characterized by an ongoing pattern of inattention and, or hyperactivity, impulsivity that interferes with functioning or development. It will be manufactured at Nesher Pharmaceuticals' manufacturing facility located at St. Louis, MO, USA.

 
Strides Announces Successful Completion of US FDA Inspection at Its Flagship Facility in Bangalore
Strides Pharma Science Limited (Strides) recently announced that its formulations facility in Bangalore recently underwent a USFDA inspection that ended on November 2, 2018. The inspection was completed successfully with Zero 483 observations. The facility (KRS Gardens) in Bangalore is the largest facility for the company and has capability in several dosage formats including tablets, capsules (both hard gelatin and soft gelatin), ointments, creams and liquids. The facility supports several important current and future submissions for the US Market. Shares of Strides Pharma Science Ltd was last trading in BSE at Rs.419.8 as compared to the previous close of Rs. 424.5. The total number of shares traded during the day was 74032 in over 1459 trades. The stock hit an intraday high of Rs. 434 and intraday low of 417.3. The net turnover during the day was Rs. 31442140.

 


 
Indoco Announces USFDA Clears Their Goa Plant II & III
Indoco Remedies announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for their sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa. The inspection was held from 27th May, 2019 to 4th June, 2019, where the Company had received 4 observations (483s). Commenting on this positive development, Ms. Aditi Kare Panandikar, Managing Director – Indoco Remedies Ltd. said, “We are happy to receive the EIR in less than two months from the date of inspection. This is encouraging, as the site has been endorsed with the VAI status twice this year, by the US Regulators. The recent inspection was a Pre-Approval Inspection for 3 ANDAs of injectable products filed through our partners.” The Company has 33 ANDAs pending for approval, out of which, 17 are for ophthalmics, 5 are for injectables and 11 are for solid dosages from the site.

 


 
Alvotech and Cipla Gulf Enter Into a Partnership for the Commercialization of Key Biosimilar in Select Emerging Markets
Reykjavik, Iceland & Mumbai: Biopharmaceutical company Alvotech and Cipla Gulf FZ LLC (“Cipla Gulf”), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited (BSE: 500087; NSE: CIPLA EQ; hereafter referred to as "Cipla"), today announced that Alvotech and Cipla Gulf have entered into an exclusive partnership for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets. AVT02 is a mAb biosimilar to AbbVie’s HUMIRA®, which is a leading drug indicated for the treatment of several autoimmune diseases, including (but not limited to) Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Plaque Psoriasis (PP), Psoriatic Arthritis, Ulcerative Colitis (UC), and Crohn’s Disease (CD). It neutralizes the Tumor Necrosis Alpha (TNF-α) involved in systemic inflammation and the above-mentioned diseases. AbbVie’s HUMIRA® recorded sales of about US$20 billion in 2018, making it the largest-selling blockbuster medicine worldwide. Under the partnership, Alvotech will be responsible for development and supply of the product, while Cipla Gulf will be responsible for registration and commercialization. Alvotech’s AVT02 is in Phase-3 clinical development ahead of filing with the European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) by early 2020. Robert Wessman, Alvotech’s founder and Chairman said: “We are very proud to announce our strategic alliance with Cipla, a leading global company with over 84 years of history. By partnering with Cipla, Alvotech gains access to Cipla’s strong commercial network in select emerging markets and deep market experience, which will ultimately benefit patients who will get better access to high-quality biosimilars.” Nishant Saxena, CEO, International Business (Europe & Emerging Markets), Cipla, said: “This is a significant addition to our portfolio of offerings in the global biosimilars space which includes trastuzumab, bevacizumab, etanercept and pegfilgrastim. Adalimumab is the highest-selling pharmaceutical product in the world and the preferred anti-inflammatory treatment option for several autoimmune diseases. We look forward to partnering with Alvotech and leveraging our own strong commercial strengths and capabilities to make this highly effective treatment option available to patients in several countries.”

 


 
Ion Exchange inaugurates its new R&D Centre in Patancheru, Telangana
Hyderabad & Mumbai: Leaders in water and environment management solutions, Ion Exchange (India) Limited, today announces the launch of its new Research & Development Centre at Patancheru in Telangana. The centre will focus on the company’s Chemicals, Resins and Membranes business. It will also provide technical and scientific support to the company’s existing technology and engineering segments for designing new processes and products. With an investment of around INR 300 million, the R&D Centre will develop new resins, membranes, polymers and speciality chemical technologies related to water, waste water treatment, process separation and purification, speciality process application and catalysis. The microbiology lab within the centre will lay emphasis on enzyme research and application specifically for the textile and food & beverage industry. Many of these products will be import substitutes with very large potential for enhancing the company’s exports. This state-of-the-art R&D centre is spread over 24,000 sq ft and certified by the Department of Scientific and Industrial Research (DSIR). It includes latest analytical instruments and is manned by a team of highly qualified and experienced researchers. Speaking during the inauguration of the R&D centre, Mr. Rajesh Sharma, Chairman and Managing Director, Ion Exchange (India) Limited said, “Ion Exchange has been in the forefront of R&D in water and waste water management since 1965. Being pioneers in this industry we have been investing a significant portion of our revenues in research and new technology development thereby maintaining our leadership in markets we serve. Our new R&D centre which is an expansion of our current research and development facility in Hyderabad and Navi Mumbai and will provide an impetus to enhance our competitiveness not only in India but globally. Through our innovations and R&D initiatives we will continue to ‘Make in India’ cutting edge sustainable solutions for industries, institutions, homes and communities”. With continued innovations, the new R&D centre will offer newer solutions to Ion Exchange customers in India and across geographies it serves.

 


 
Pharma Exports Soar 26%
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.

 


 
Sartorius Stedim Biotech Launches New Services for Mammalian Cell Bank Manufacturing
GOETTINGEN, Germany and GLASGOW, UK (B3C newswire): Sartorius Stedim Biotech (SSB), a leading partner of the biopharmaceutical industry, recently announced the launch of new services for mammalian cell bank manufacture under GMP conditions. These services are offered by its subsidiary, Sartorius Stedim BioOutsource, an experienced contract testing organization (CTO) based in Glasgow, UK, and in Cambridge, Massachusetts, USA. Based on these new services, Sartorius Stedim Biotech now offers the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells. This activity will be conducted in a custom-designed 260 m2 GMP cleanroom facility that has been audited and approved in 2018 by the Medicine and Healthcare Products Regulatory Agency (MHRA) according to the latest guidelines. Exclusively dedicated to mammalian suspension cell lines, the facility uses selected equipment that enables closed-system manufacture of GMP-compliant cell banks, from vial thaw to automated filling. For maximum process reliability and assurance of sterility, this entire manufacturing service is offered as a fully qualified broth technology platform. The GMP manufacture of master cell banks is a critical step during the development of biopharmaceutical drugs where time is always key. To ensure the best possible timelines, Sartorius Stedim Biotech cell bank manufacturing is offered in a package along with cell bank characterization services that the company has been providing for more than ten years. The combination of its new manufacturing services and its established characterization service for mammalian cell banks allows clients to work with SSB as a single-source provider from vial thaw to released cell banks. Up to 500 cell bank vials are produced during a manufacturing run, followed by full characterization, genetic stability assessment in compliance with EU and FDA guidelines, and release by the respective qualified person. The cell bank vials produced are then shipped to the client or transferred to a long-term storage facility. In addition, these cell bank manufacturing and characterization services are a perfect match for the cell line development services based on Sartorius Stedim Cellca’s CHO expression platform. With all three services combined – cell line development, cell bank manufacturing, and cell bank characterization – Sartorius Stedim Biotech supports clients as a total solutions provider from DNA to released GMP cell bank within a 10-month timeline. “We’re really proud that we now offer even more comprehensive services that can be easily combined with those for CHO cell line development and biosafety. As a result, we provide our clients with an integrated package that saves considerable time and minimizes risks. Furthermore, they will benefit from client-focused customer service with a single point of contact throughout their entire development and manufacturing projects,” stated Lucia Rieger, Product Manager for Protein Expression Systems.

 


 
Cadila Pharma Bags TISS Leap Vault CLO Awards in Two Categories
Ahmedabad: Cadila Pharmaceuticals bagged two TISS LeapVault CLO awards under the categories of ‘Program for Sales Enablement’ and ‘Social Media Based Learning Program’. Tata Institute of Social Science-Leapvault CLO Summit and Award is a prestigious event, which brings together leaders from human resource, corporate learning, coaching, organisation and leadership development. This award was conferred on the Learning and Development (L&D) team of Cadila Pharma for their initiative of training the field force using WhatsApp.
When the world is trying to build specialized apps for specific functions, Cadila’s L&D team thought of an idea of using the existing platform of Whatsapp to increase their reach. Hence, the team merged e-learning with social media for the training of the field force. The L&D team of Cadila Pharmaceuticals began its training program in January 2019. The objective of the training is to build customer-centric capabilities of its diversified field force using new-age learning tools. The company adopted a mix of classroom teaching and e-learning using WhatsApp as a tool to ensure the application of the key learnings. The L&D team trained 1,999 employees across 13 locations in ten days. For the remainder of the training program, the team used WhatsApp to ensure a regular connect was maintained with the teams. Through innovative weekly campaigns of selfies, audio and vide
Dr. Sunil Singh, the Chief Human Resource Officer of Cadila Pharmaceuticals and Mr. Ajay Tyagi, Chief Learning Officer of Cadila Pharma were the brains behind this creative solution. “We observed 30% adoption among our colleagues, which is higher than the standard 20-25% usually seen in e-learning. This initiative is one more step towards our vision of becoming a progressive, transformative and a caring organization.” Dr Singh said in a statement.
This recognition comes recently after two awards won by Cadila Pharmaceuticals for the “Best Warehouse Workforce Award” at the Second Annual Future Warehouse Summit Awards 2019 in the month of July 2019 and a WorldStar Packaging Award in May 2019. Cadila Pharma has been making bold moves to ensure a culture of excellence. With multiple initiatives like four-day summer break, leave on first Saturdays and flexi timings, Cadila Pharma has remained committed towards breaking the age-old practices of manufacturing industry. Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. Being a care-focused, research-driven company, we are committed to complying with the highest ethical standard in clinical research and medical practice.

  

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