Tadalafil | Zydus Lifesciences | FDA Orange Book | Finished Dosage Forms

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 713 NEWS #PharmaBuzz

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INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
713 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

250 All APIs, 196 USDMF, 48 CEP/COS, 7 JDMF, 90 EU WC, 102 KDMF, 26 NDC API, 1 VMF, 82 Listed APIs

250 All APIs
196 USDMF
48 CEP/COS
7 JDMF
90 EU WC
102 KDMF
26 NDC API
1 VMF
82 Listed APIs

DEVELOPMENTS

128 Drugs in Development

128 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1256 FDF Dossiers, 1074 FDA Orange Book, 182 South Africa

1256 FDF Dossiers
1074 FDA Orange Book
182 South Africa

INSPECTIONS & REGISTRATIONS

20 FDA, 14 EDQM, 28 WHO-GMP, 7 GDUFA

inspections
20 FDA
14 EDQM
28 WHO-GMP
7 GDUFA

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About

Zydus Cadila is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin...

CPhI Worldwide, MilanCPhI Worldwide, Milan

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08-10 October, 2024

Fiera Milano, Italy
KY/TN Water Profession...KY/TN Water Professionals

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08-11 September, 2024

Louisville, KY
Pharmaconex 2024Pharmaconex 2024

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08-10 September, 2024

Egypt International Exhibition Centre

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Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr....

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INTERVIEW #SpeakPharma

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“Topscience’s expertise in producing pharma-grade sodium hyaluronate has made it a leader in China”

This week, SpeakPharma interviews Fu Qiang, Deputy General Manager of Shandong Topscience Biotech, one of China’s leading producers of sterile sodium hyaluronate. Fu discusses the company’s focus on pharmaceutical and high-end applications, the intricacies of aseptic production, and the promising future of the sodium hyaluronate market. 🔑 HIGHLIGHTS// leading producers of sterile sodium hyaluronate/ focus on pharmaceutical and high-end applications China is a major player in the global biotechnology industry. How is Topscience Biotech positioned to compete in this dynamic market? Shandong Topscience Biotech was founded in 2005 and entered the hyaluronic acid industry in 2008. With a history of 16 years in this market, sometimes called a “red ocean” by industry insiders because of the intense competition, Topscience Biotech has carved a distinctive niche for itself within the highly competitive Chinese biotechnology landscape. The sodium hyaluronate market doesn’t have a long development history, nor is it monopolized. There are many “players” in the market. But most of them aren’t technically very strong. They are primarily focused on low-tier applications in food and cosmetics and have no means or ability to achieve high-quality, high-tech products. In contrast, Topscience Biotech has decisively adopted a strategic approach by avoiding the over-competitive, low-end market and focusing on pharmaceutical and high-end application fields with higher technical barriers and fewer competitors. Sodium hyaluronate is currently one of the company’s core products, encompassing food grade, cosmetic grade, medical device grade, and pharmaceutical grade variants. Globally, there are only a handful of companies in the pharmaceutical sector capable of producing pharmaceutical grade sodium hyaluronate, with an even smaller number based in China. We are among the five or six companies competing on the global stage. We have created a competitive barrier by concentrating on the pharmaceutical grade field, which demands higher technical expertise, and by leveraging our aseptic production technology. 🔑 HIGHLIGHTS// avoiding the over-competitive low-end market/ leveraging aseptic production technology/ created a competitive barrier Topscience Biotech is known for its commitment to quality standards. Can you talk about the company's approach to maintaining the highest quality control measures? Topscience Biotech’s reputation for quality is foundational to its success. A crucial aspect of Topscience Biotech’s quality strategy is its mastery of aseptic production technology for pharmaceutical grade sodium hyaluronate, a field in which it is a leading Chinese company. This strategy enables us to avoid price competition and sustain our market dominance. Our approach is in harmony with the national industrial development objectives. It fosters advancements in new quality productivity. We invested significantly in building a robust quality management system that encompasses every stage of the production process, from raw material sourcing and production to final product release. The production of sterile sodium hyaluronate imposes exceptionally high standards on the entire production environment and process flow. Aseptic production, particularly the later purification stages, necessitates stringent control over impurities and endotoxins and demands an exceptionally clean production environment. The construction of the entire system, including personnel, equipment, material management, document control, clean control, and other aspects, is subject to rigorous standards. This is a systematic undertaking. To realize this vision, we engaged a professional organization to design the workshop interior and collaborated with expert manufacturers on research. The resulting system was meticulously designed to optimize the production process. It’s important to note that the investment in this specialized production line far surpasses that of conventional ones. 🔑 HIGHLIGHTS// robust quality management system/ stringent control over impurities and endotoxins Can you elaborate on the specific advantages of STERILEHYA, compared to other sodium hyaluronate products available in the market? The advantage of sterile sodium hyaluronate, such as STERILEHYA, lies not only in the control of the process and aseptic production but also in the fact that it provides new possibilities for product development downstream. Unlike traditional non-sterile sodium hyaluronate, which requires subsequent sterilization, aseptic preparation is the initial step in our production process. Sodium hyaluronate is sensitive to high temperatures, which can cause it to break down. This presents a challenge for those requiring sterile materials. STERILEHYA offers a solution by providing pre-sterilized sodium hyaluronate, eliminating the need for customers to perform their own sterilization processes. This not only saves time but also reduces experimental costs and avoids the risk of degradation during sterilization. STERILEHYA is particularly useful for sterile medicinal products and medical devices that cannot undergo final container sterilization, as it can be incorporated directly into these products without further sterilization steps. This technology has gained widespread recognition in the international market, particularly within ophthalmic surgery and injection applications. As the domestic pharmaceutical industry continues to advance, the demand for sterile sodium hyaluronate, such as STERILEHYA, is steadily increasing within the Chinese market. 🔑 HIGHLIGHTS// new possibilities for product development downstream/ saves time and reduces experimental costs/ ophthalmic surgery and injection applications Biotechnology research is fast-paced. Can you elaborate on Topscience Biotech’s specific strategies for staying ahead of the curve? Topscience Biotech’s core competitiveness stems from its continuous technological innovation, driven by a formidable team of technical experts dedicated to new product development. It has persistently expanded its product line with a spirit of excellence and innovation. Our R&D team has a deep understanding of the properties of sodium hyaluronate and continuously explores its potential interactions with other chemical substances. In recent years, we have introduced a series of sodium hyaluronate derivatives to the market, such as sodium acetylated hyaluronate and zinc hydrolyzed hyaluronate, which are now being used by well-known multinational companies Besides this, we have made significant investments in R&D to expand our product line beyond sodium hyaluronate, such as chondroitin sulfate sodium and alpha-arbutin. This diversification demonstrates the company’s commitment to exploring new opportunities within the biotechnology sector. Facing a complex and changing market environment, Topscience Biotech has chosen to stick to its development strategy. We focus on making raw materials, making them refined and specialized, better serving customers, and empowering them to do what they want to do. From food grade to cosmetics grade, medical device grade, pharmaceutical grade, and then to sterile grade, Topscience Biotech’s product line continues to extend to the high-end, confirming the growth logic of “specialized and new” enterprises. The company boasts of a robust R&D team comprising numerous doctors, with over 40 employees holding intermediate professional titles or higher, all committed to innovation. To foster a synergistic research environment, Topscience Biotech has forged strong industry-university-research collaborations with renowned institutions such as Jiangnan University and Shandong University. 🔑 HIGHLIGHTS// formidable team of technical experts/ expand product line beyond sodium hyaluronate What are some of the most exciting opportunities you see for Topscience in the coming years? We maintain a cautiously optimistic outlook on the future of the sodium hyaluronate industry. Opportunities and challenges coexist. While the sector currently faces certain policy and market challenges, the long-term trajectory is promising, driven by increasing market demand and technological advancements. The aging population, with its growing need for orthopedic and ophthalmic care, presents a broad market opportunity for sodium hyaluronate products. Beyond this, the burgeoning medical beauty market offers immense potential for sodium hyaluronate-based products. More and more consumers are beginning to pay attention to the quality and safety of medical beauty products, for which sodium hyaluronate is a critical ingredient. This trend creates significant growth prospects for high-quality raw material suppliers, like Topscience Biotech. Our technological edge and robust supply capacity have positioned us as a preferred partner for numerous medical beauty companies in the high-end market. In today’s uncertain global economy, companies like Topscience Biotech, specializing in niche markets and driving innovation, offer invaluable models for China’s manufacturing sector to emulate. Topscience Biotech remains an irreplaceable component of the international industrial chain due to its inherent advantages. It is imperative that we optimize our role within this chain to elevate and expand our industry’s influence. We anticipate continued breakthroughs from Topscience Biotech, bringing more surprises and disruption to the pharmaceutical industry. 🔑 HIGHLIGHTS// aging population with growing need for orthopedic and ophthalmic care/ broad market opportunity for sodium hyaluronate products/ burgeoning medical beauty market/ technological edge and robust supply

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DATA COMPILATION #PharmaFlow

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US drug shortages hit record high in Q1 2024, impacts cancer, ADHD drugs; Lilly, Novo ramp up production

Drug shortages are threatening healthcare systems the world over. Be it the US, Canada, Europe or Africa, drug scarcities are straining healthcare systems and costing lives.In the US, the first quarter (Q1) of 2024 saw a staggering 323 drug shortages, the highest number recorded since the American Society of Health-System Pharmacists (ASHP) began tracking such data in 2001. However, Q2 2024 saw active drug shortages reduce to 300 drugs.While the shortages span a wide range of medications, five categories have been severely impacted in the US — central nervous system drugs, antimicrobials, hormone agents, injectable fluids and electrolytes, and chemotherapy drugs. Other critical medications in short supply include drugs to treat attention deficit hyperactivity disorder (ADHD).View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)Chemo scarcities spark concerns; vaccine shortage hampers mpox response in AfricaIn the US, shortage of at least 21 chemotherapy drugs has impacted cancer treatments. A survey undertaken by the National Comprehensive Cancer Network found 89 percent of participating centers reporting shortages of at least one critical systemic anticancer therapy. These included drugs like vinblastine, etoposide and topotecan. Since early 2023, supply issues have led to what’s now known as the “carboplatin shortage”, a key platinum-based chemo drug that is impacting cancer treatment. Carboplatin is crucial for treating various cancers, including ovarian, lung, and breast cancer.The good news is that there has been a reduction in shortages of platinum-based chemo drugs such as carboplatin and cisplatin. In fact, the FDA website now mentions the shortage of cisplatin as resolved. However, the shortage of carboplatin persists.Meanwhile, Africa is facing an acute shortage of diagnostic kits, treatments and vaccines to fight the outbreak of monkeypox (mpox). The Africa Centers for Disease Control and Prevention estimates it would need 10 million vaccines to stop the outbreak. Bavarian Nordic’s Jynneos is currently the only widely approved mpox vaccine, and countries like the US, Spain, France and Germany have pledged doses of Jynneos to help Africa fight the outbreak.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Drug shortages impacts ADHD patients in US; Canada implements tiered systemThe US Food and Drug Administration (FDA) first reported a shortage of Adderall, a common ADHD treatment, in October 2022. Since then, the shortage has spread to other crucial medications like Ritalin, Vyvanse, and Focalin. This is a significant issue for the roughly 10 million adults and six million children in the US who rely on such drugs to manage their ADHD symptoms.An already concerning shortage of ADHD medications in the US has the potential to worsen due to some recent events. The Centers for Disease Control and Prevention (CDC) issued a health advisory in June, warning that the arrest of two telehealth executives from Done Global, a digital health company, could exacerbate the ADHD medication shortage. Done Global was accused of illegally distributing Adderall online. The arrests could disrupt care not only for Done Global patients but also for those who use other telehealth services.Meanwhile, Canada has implemented a tiered system for addressing drug shortages, with tier 3 shortages being those with the greatest potential impact on the country’s drug supply and healthcare system. Currently, there are 20 drugs listed under tier 3.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) GLP-1 drug shortages create US$ 1 bn shadow industry; Lilly, Novo expand capacitiesThe shortage of glucagon-like peptide-1 (GLP-1) receptor agonists, such as Ozempic, Saxenda, Trulicity, Victoza, Mounjaro, and Zepbound, has been grabbing headlines. These drugs are used in the treatment of diabetes and in weight management.The shortage of these drugs has led to a surge in demand for compounded versions of these medications, creating both opportunities and significant risks. While the FDA’s Food, Drug, and Cosmetic Act allows it to turn a blind eye to pharmacists producing and selling non-approved compounded versions under certain circumstances, this practice has led to a billion-dollar shadow industry of compounded GLP-1 drugs.Eli Lilly has discovered compounded drugs advertised as tirzepatide (Mounjaro and Zepbound) with significant safety, sterility, and efficacy issues. In response to the safety risks, Lilly has taken legal action against several wellness centers, medical spas, and other sellers in the US.To address the supply issues, Lilly has announced its largest manufacturing investment yet, investing an additional US$ 5.3 billion at its Indiana site. Similarly, Novo Nordisk’s parent company is acquiring Catalent for US$ 16.5 billion to increase Wegovy production. Novo is also investing US$ 4.1 billion to develop a new manufacturing facility in Clayton, North Carolina (US).The FDA website continues to list Novo and Lilly’s GLP-1 drugs as “Currently in Shortage”, even though the drugmakers say otherwise. The EMA website says the shortage of Novo’s Wegovy has been resolved but Lilly’s Trulicity and Novo’s Saxenda continue to be in shortage.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) FDA works closely with cancer drugmakers; France introduces roadmap to address drug shortagesApart from pharma companies, health authorities and governments are also taking steps to reduce drug shortages. FDA is working closely with five cancer drug manufacturers to increase production capacities. It has also facilitated the re-entry of a previously discontinued cisplatin product into the market.On the legislative front, the US Senate Finance Committee has proposed a draft of a policy that would incentivize generic drug manufacturers to prioritize production of essential medications. These incentives include minimum three-year contracts with stable pricing, contingency contracts with alternate manufacturers, transparency in quality control issues, and modifications to the Medicaid Drug Rebate Program. France, like most European nations, is also facing shortages of medicines like insulin and anti-cancer drugs. But most problematic are its shortages of antibiotics, paracetamol and corticoids. The French government has introduced a new three-year "roadmap" (from 2024 to 2027) to address these shortages. A significant step in this direction is the planned opening of the first European paracetamol factory in Toulouse in 2025, which will help reduce Europe’s dependence on China, India, and the US for this widely used medication.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Our viewThe global drug shortages underscore the fragility of pharmaceutical supply chains and the urgent need for reform. Longstanding drug shortages, particularly those affecting cancer treatments, antibiotics, and essential medications often stem from the low profitability of generic drugs.While investments in manufacturing capacity and regulatory measures are steps in the right direction, a more comprehensive, concerted global approach is needed to resolve the deep-seated systemic issues in the pharmaceutical industry.