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Company Tracker: Pfizer turns to acquisitions as Covid products’ sales nosedive

Over the last five years, a lot has changed for Pfizer Inc, one of the world’s leading pharmaceutical companies based on pharma sales revenue. From entering into an agreement with German biotechnology company BioNTech SE in August 2018 for joint research and development of mRNA-based influenza vaccines to merging its off-patent branded and generic drug business, known as Upjohn, with Mylan to form Viatris and launching Covid-19 vaccine Comirnaty and antiviral drug Paxlovid during the pandemic, the New York-headquartered pharma giant has witnessed substantial transformation in the recent past.The launch of Covid products was undoubtedly the biggest event for the 174-year-old drugmaker, propelling it to the number 1 slot in 2021 with a turnover of US$ 81.3 billion, surpassing competitors such as AbbVie, Johnson & Johnson, Novartis, Roche, Bristol Myers Squibb, Merck, and several others. In 2022, Pfizer further consolidated its position, with revenues exceeding US$ 100 billion, largely due to the success of its Covid products. This success of Covid products filled Pfizer’s coffers, allowing it to expand through the acquisition of smaller companies. Pfizer’s new brand identity and logo, unveiled in 2021, signaled the company's shift from "commerce to science".Pfizer commercially operates through two segments — Biopharma, or its innovative science-based biopharmaceutical business that posted revenues worth US$ 98.98 billion in 2022, and Pfizer CentreOne (PC1), a global contract development and manufacturing organization as well as a leading supplier of specialty active pharmaceutical ingredients (APIs) with US$ 1.3 billion in 2022 revenues.Pfizer’s core therapeutic areas are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines and anti-infectives.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel)Pfizer in acquisition overdrive: Buys Seagen for US$ 43 bn, Biohaven for US$ 11.6 bnPfizer has been utilizing its war chest generated during the pandemic in acquiring companies that would help grow the business when Covid is behind us and its other best-selling drugs (such as Ibrance, Vyndaqel/Vyndamax, Xeljanz and Xtandi) face expiration of patents. In November 2021, Pfizer snapped up Trillium Therapeutics for US$ 2.22 billion. Trillium is a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. In March 2022, Pfizer acquired Arena Pharmaceuticals for US$ 6.7 billion, a company that develops novel therapies to treat immune-inflammatory ailments. Then, in Oct 2022 it completed the US$ 11.6 billion buyout of migraine specialist Biohaven. This brought Biohaven’s leading oral migraine drug in the US – Nurtec ODT (rimegepant) – into Pfizer’s fold. In June 2022, Pfizer completed the acquisition of ReViral Limited, gaining access to its experimental drugs used to combat respiratory syncytial virus (RSV) infections. In October, Pfizer paid US$ 5.4 billion for blood disorder drugmaker Global Blood Therapeutics (GBT). Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – to its portfolio.And this month, Pfizer announced it will acquire Seattle-based cancer specialist Seagen for US$ 43 billion, its biggest acquisition in the recent past. “We are not buying the golden eggs,” Albert Bourla, CEO of Pfizer, said post the announcement. “We are acquiring the goose that is laying the golden eggs.”The Pfizer-Seagen deal is also the largest biopharma acquisition since 2019, when BMS bought Celgene for US$ 74 billion. Seagen is a leader in antibody-drug conjugate (ADC) technology. This deal will bring four commercial medicines (Adcetris, Padcev, Tukysa and Tivdak) and a deep pipeline of ADC candidates to Pfizer’s fold.Seagen is likely to post US$ 2.2 billion in revenues this year, which is expected to grow to over US$ 10 billion (risk-adjusted) by 2030. Earlier this year, Bourla had said the company has planned to use its “extraordinary firepower” to buy products that will deliver US$ 25 billion in incremental revenue by 2030. While Seagen will bring in US$ 10 billion, another US$ 10.5 billion will come from Arena, Biohaven, GBT and ReViral.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Diminishing demand for Covid products, expiring patents to drag turnover downPfizer’s turnover has nearly doubled since 2018, when it was at US$ 53.6 billion. In July 2019, Pfizer had announced the plan to combine Upjohn with Mylan to form a new company — Viatris. With the separation of the Upjohn business and the formation of a consumer healthcare joint venture with GSK in 2019, Pfizer transformed into a more focused player in innovative medicines and vaccines. However, this restructuring measure also led to a drop in its turnover to US$ 51.8 billion in 2019 and to US$ 41.9 billion in 2020. From the number three slot in 2018 (behind J&J and Roche), Pfizer’s ranking fell to eight in 2020. However, Covid turned its fortunes yet again and its turnover increased to US$ 81.3 billion in 2021.When we split Pfizer’s 2022 revenues of US$ 100.3 billion, we notice that its portfolio has 10 products with sales greater than US$ 1 billion. These include the Covid-19 vaccine Comirnaty with US$ 37.8 billion in revenues, Paxlovid with US$ 18.9 billion, anticoagulant Eliquis with US$ 6.5 billion, and the Prevnar family of pneumococcal vaccines with US$ 6.3 billion in revenues. Pfizer's partner BMS recorded sales of US$ 11.8 billion for Eliquis in 2022.With a drop in Covid cases, demand for Comirnaty and Paxlovid has decreased significantly. In 2023, Comirnaty’s revenue is likely to drop 64 percent to around US$ 13.5 billion, and Paxlovid’s revenue is likely to plummet by around 58 percent to around US$ 8 billion.Pfizer expects its 2023 revenues to be between US$ 67 billion and US$ 71 billion, reflecting an operational decline of over 30 percent. However, when we exclude the revenues of Covid products, we are likely to see a growth in revenues of around 7 to 9 percent, coming primarily from new product launches, recently acquired products and Pfizer’s in-line portfolio.“Pfizer expects 2024 sales of Covid products to stabilize, then starting in 2025 and continuing in 2026 and beyond, it expects to see an increase in Covid-19 vaccination rates, assuming the successful development and approval of a Covid-flu combination product,” said Bourla. Last December, Pfizer and BioNTech received fast track designation from the US Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and Covid-19, which aims to help prevent two respiratory diseases with a single injection.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Stars in Pfizer’s pipeline — RSV, pneumococcal and meningococcal vaccinesIn 2022, Pfizer spent US$ 11.4 billion in research and development, up 12 percent from its R&D spend in 2021. It has a power-packed pipeline with 110 programs, including 72 new molecular entities. Out of the 110 programs, 33 are in oncology, 23 in inflammation and immunology, 19 in vaccines, 15 in internal medicines, 12 in rare diseases and eight in anti-infectives.However, the stars in Pfizer’s pipeline are its vaccine candidates. Pfizer’s RSV vaccine candidate RSVpreF is being developed for pregnant women (to help protect their babies from RSV after birth) and individuals 60 years of age or older for the prevention of lower respiratory tract disease caused by RSV. The vaccine recently received support from the FDA's advisory committee, and a decision on its use for older adults is expected by May 2023.The agency has also granted priority review to the maternal RSV vaccine, with an action date of August 2023. If approved, it would be the first vaccine for pregnant women to help protect against the complications of RSV disease in infants from birth through six months.Recently, FDA also designated Prevnar 20 for priority review in children aged six weeks through 17 years. Six months ago, Merck’s Vaxneuvance had received pediatric approval. The Merck vaccine defends against 15 serotypes, as compared to 13 strains covered by Pfizer’s Prevnar. However, Merck’s edge could be short-lived as Prevnar’s next-generation vaccine protects against 20 serotypes. The US regulatory agency has also accepted the BLA (biologics license application) review of Pfizer’s pentavalent meningococcal vaccine candidate — MenABCWY — in adolescents with the PDUFA date of October 2023. Moreover, the company has announced positive top-line results from a phase 3 study of its hemophilia B gene therapy candidate, fidanacogene elaparvovec.Besides this vaccines and therapies, FDA is going to decide on several other Pfizer drugs in 2023, such as ritlecitinib for alopecia, elranatamab for multiple myeloma, etrasimod for ulcerative colitis, and Abrilada, a biosimilar of AbbVie’s blockbuster Humira (adalimumab).View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Our viewAs of today, the sweet spot of US$ 100.3 billion in 2022 revenues posted by Pfizer surely looks like a one-off. Though the drug behemoth’s vaccine pipeline looks promising, its shopping list reflects a huge reliance on oncology for future growth.While only time can tell which of those bets will work and which won’t, it looks like Pfizer has capitalized on the lead the pandemic granted it to race ahead of competition.(All financial and drug pipeline-related information has been taken from the Pfizer website.)

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23 Mar 2023

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Top 100 pharma & biotech deals in 2022

The pandemic years haven’t been great for dealmaking. Our analysis of top 10 biopharma M&A transactions shows that after a blockbuster 2019, when the combined value of top 10 biopharma M&A transactions had hit US$ 207 billion, M&A activity decreased in the next two pandemic years, with the combined value of top 10 deals dropping to US$ 97 billion in 2020 and to US$ 53 billion in 2021.In 2022, the combined value of the top 10 M&A transactions reached US$ 69 billion. However, our analysis shows that total M&As increased only marginally — from US$ 93.6 billion in 2021 to US$ 98.7 billion in 2022. In fact, the total M&As by upfront cash dropped from US$ 77.6 billion to US$ 76.3 billion. Our data does not include deals in medical devices, diagnostics and animal health.Industry watchers had predicted 2022 to be the year of M&As, as Big Pharma were expected to spend the booty amassed during the pandemic on acquisitions. But record inflation, a looming recession, the ongoing Russia-Ukraine war, volatile stock markets and some regulatory moves (such as the US Inflation Reduction Act) deterred companies from loosening their purse strings.The result was another lackluster year for M&As. The top 10 M&A deals in 2022, selected based on upfront cash paid, include Amgen’s Horizon takeover (US$ 27.8 billion), Pfizer’s purchase of Biohaven (US$ 11.6 billion) and Global Blood Therapeutics (US$ 5.4 billion), and BMS’ purchase of Turning Point Therapeutics (US$ 4.1 billion).View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available)Amgen buys Horizon in 2022’s biggest deal; picks up ChemoCentryx for US$ 3.7 bnThe year began on a sluggish note with M&A activity picking up in the second half. The biggest deal of the year — Amgen’s acquisition of Horizon Therapeutics — came in December.Last November, Horizon Therapeutics had said it had drawn buyout interest from players like Amgen, Sanofi and Johnson & Johnson. Just weeks before Christmas, Amgen announced its US$ 27.8 billion takeover of Horizon. The Irish firm develops medicines for rare autoimmune and severe inflammatory diseases mostly sold in the US. Once complete, the deal will give Amgen access to Horizon’s two best-selling drugs – thyroid eye disease drug Tepezza and gout treatment Krystexxa. Owing to the Amgen-Horizon deal, the rare diseases therapeutic area attracted the highest amount of M&As (by deal size). The second largest was neurology, with Pfizer taking over Biohaven and UCB Pharma acquiring Zogenix.In August, Amgen had picked up Californian biotech ChemoCentryx for US$ 3.7 billion to help broaden its portfolio of inflammation and kidney drugs. The deal brought ChemoCentryx’s potential blockbuster treatment for inflammatory disorders — Tavneos (avacopan) — into Amgen’s fold, along with three early-stage drug candidates that target ulcerative colitis, skin conditions and cancer.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Pfizer acquires Biohaven for US$ 11.6 bn, Global Blood Therapeutics for US$ 5.4 bnThe pandemic brought huge revenue gains for Pfizer and the drug behemoth decided to use the cash by cherry-picking companies that would strengthen its portfolio. In May, Pfizer notched up New Haven-based Biohaven Pharmaceuticals for US$ 11.6 billion. The deal gave Pfizer the rights to Nurtec ODT, a leading oral migraine drug in the US and a potential blockbuster. Biohaven has six other migraine drugs in development and Pfizer expects them to top US$ 6 billion in annual sales. Biohaven is Pfizer’s largest purchase since 2016, when it bought Medivation for US$ 14 billion.Later in the year, Pfizer acquired blood disorder drugmaker Global Blood Therapeutics (GBT) for US$ 5.4 billion with the intention of expanding its sickle cell disease portfolio. Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – into its portfolio. Pfizer expects all these blood disorder drugs to contribute US$ 3 billion in peak sales.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) BMS buys Turning Point for its oncology pipeline; Takeda acquires Nimbus LakshmiIn June, Bristol Myers Squibb acquired California-based drug developer Turning Point Therapeutics for an upfront cash amount of US$ 4.1 billion to bolster its cancer drug pipeline. The deal gives BMS access to Turning Point’s star candidate, repotrectinib, in trials to treat non-small cell lung cancer (NSCLC) along with other advanced solid tumors. BMS expects repotrectinib to be approved in the US in the second half of 2023 and become a standard-of-care therapy for certain patients with NSCLC.In December, Takeda Pharmaceutical acquired US-based Nimbus Lakshmi, a subsidiary of Nimbus Therapeutics that works on TYK2 programs, for US$ 4 billion in upfront payment. Through the deal, Takeda won Nimbus’ experimental psoriasis drug TAK-279. Takeda will make two milestone payments of US$ 1 billion each to Nimbus if TAK-279 achieves annual net sales of US$ 4 billion and US$ 5 billion.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) GSK enters pneumococcal vaccine race with Affinivax deal; UCB buys ZogenixGSK – one of the world’s largest vaccine makers by sales – is set to compete for a share of the lucrative pneumococcal vaccine market with its purchase of Affinivax for a potential US$ 3.3 billion. Through the deal, the British drugmaker has gained access to the Boston-based biopharma’s 24-valent pneumococcal vaccine candidate, along with its vaccine development technology platform MAPS (Multiple Antigen Presenting System) and other assets. GSK believes the vaccine candidate will help it challenge market leader Pfizer’s blockbuster Prevnar range of vaccines.GSK also paid US$ 1.9 billion for American drug developer Sierra Oncology and gained access to the latter’s targeted therapies for the treatment of rare forms of cancer. Sierra’s lead candidate momelotinib is being developed to address the unmet medical needs of anemic myelofibrosis patients. GSK believes the drug will work better at treating anemia than the currently approved JAK inhibitors on the market. FDA will decide on the drug’s approval by June 2023.Belgian biopharma UCB paid US$ 1.9 billion for Zogenix, expanding its portfolio of treatments for specific and rare forms of epilepsy drugs. The acquisition will help UCB deepen its foothold in the epilepsy market, adding to its existing line of four products, including Vimpat and Briviact.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Merck inks deal with Kelun Biotech; Regeneron buys rights to Sanofi’s cancer drugSeveral drugmakers announced collaborations where milestone payments took precedence over upfront payments. In one such deal, Merck entered into a potential US$ 9.3 billion licensing and collaboration agreement with China’s Kelun Biotech that will give it rights to seven early-stage antibody-drug conjugate candidates against oncology targets. Merck paid a relatively small sum of US$ 175 million upfront to Kelun as part of the deal.After partnering with Sanofi for seven years, Regeneron Pharmaceuticals acquired the global rights to cancer drug Libtayo from the French drugmaker for an upfront payment of US$ 900 million. Regeneron paid another US$ 100 million to Sanofi after FDA approved the drug as a first-line treatment for adult patients with advanced NSCLC (to be administered in combination with platinum-based chemotherapy). As part of the deal, Sanofi will receive a royalty of 11 percent on worldwide net sales of Libtayo and will get another potential US$ 100 million in sales-related milestone payments over the next two years.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Biocon acquires Viatris’ biosim business; Biogen sells stake in Samsung Bioepis Biocon Biologics, a subsidiary of Indian drugmaker Biocon, acquired US-based Viatris’ biosimilars business for US$ 3.34 billion. The deal expanded Biocon’s biosimilar portfolio of 20 treatments – including 11 that were with Viatris – by adding therapies for treating diabetes, tumors and autoimmune diseases. According to Biocon, Viatris’ biosimilar portfolio is expected to generate over US$ 1 billion in 2023.Samsung Biologics shelled out US$ 2.3 billion to take over partner Biogen’s stake in Samsung Bioepis, which the duo had set up in 2012 to develop and manufacture biosimilars. Biogen, however, retained the commercial rights to both Byooviz (a biosimilar of Novartis’ eye drug Lucentis) and the investigational candidate SB15 (a biosimilar of Regeneron’s Eylea) along with the biosimilars of Enbrel, Humira and Remicade.View Top 100 Pharma & Biotech Deals in 2022 by Deal Size (Free Excel Available) Our viewGlobally, M&As slowed down substantially across all industries in 2022 as companies confronted challenges such as rising interest rates, a pullback in leveraged finance, bond-market jitters and the possibility of a recession. According to Refinitiv, the total value of deals announced globally fell 37 percent last year — the biggest year-over-year percentage drop since 2001.Going by these statistics, the pharmaceutical industry didn’t fare badly. In its latest ‘Pharmaceutical & life sciences: US Deals 2023 outlook’ report, PricewaterhouseCoopers has predicted a more active 2023, with “M&As to more closely resemble prior years” with a total deal value in the US$ 225 billion to US$ 275 billion range across all sub-sectors.The new year has begun on a positive note, with three M&A deals worth over US$ 4 billion being announced at last month’s JP Morgan Healthcare Conference. A series of patent expirations are going to put global prescription sales at risk through 2026. Therefore, it seems plausible that the recent momentum in M&A activities will continue throughout 2023.

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23 Feb 2023

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DMF submissions rise 12.1% in 2022; India sees 10.6% drop in Type II filings

In 2022, the world finally began to emerge out of Covid-related restrictions. Though 2020 and 2021 saw several travel-related curbs, there was no let up in the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA). In the four years between 2018 and 2021, the number of Type II DMF submissions (i.e. submissions for drug substance, drug substance intermediate, and material used in their preparation, or drug product) remained steady at over 630 per year.In 2022, the DMF submissions rose at an impressive pace of 12.1 percent. A total of 1,024 DMFs (Types II, III, IV and V) were submitted in 2022, as opposed to 913 in 2021.Last year, Type II DMF submissions increased by 7.2 percent — a total of 715 Type II DMFs were submitted in 2022 as opposed to 667 in 2021. However, of the 715 DMFs filed with the FDA, only 190 (26 percent) had their reviews completed.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) DMF submissions from India dip 10.6%, China’s filings increase 45%As always, DMFs filed from India and China were significantly higher than DMFs from other countries. However, the year saw DMF submissions from India drop by 10.6 percent. Overall DMF submission from India stood at 336, as opposed to 376 in 2021. In comparison, China’s DMF filings increased by 45 percent to 231 in 2022, as opposed to 159 in 2021. Interestingly, FDA had issued 31 Form 483s in 2022 out of which 15 were issued to Indian drugmakers. Out of 15, seven Form 483s were issued to manufacturing units belonging to four Indian API manufacturers — Lupin, Aurobindo Pharma, Torrent and Biocon Biologics.While DMFs are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products, a Form 483 is a notification sent by the FDA to a drugmaker regarding objectionable conditions at a facility. A Form 483 is issued at the conclusion of an inspection, when an investigator finds regulatory violations and/or non-compliance of good manufacturing practices. January 2023 saw a spate of Form 483s issued to Indian drugmakers, raising concerns within the pharma industry.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) India’s Metrochem API tops DMF submissionsIndia’s Metrochem API led the list of companies with the highest number of DMF submissions at 19. MSN Labs stood second with 16 submissions.Other top Indian companies were Aurobindo Pharma (15), Biophore India (15), Hetero Group (11) and Cipla (10), followed by two Chinese companies — BrightGene Bio-Medical Technology and Changzhou Pharmaceutical Factory — with 9 submissions each.The maximum number of DMF filings were for elagolix sodium (11), empagliflozin (eight), tofacitinib citrate (six), revefenacin (six), apixaban (five), brivaracetam (five), cannabidiol (five), followed by mirabegron (five) and tafamidis (five).A total of 79 DMFs were filed for the first time for 64 products, of which 28 had their GDUFA (Generic Drug User Fee Amendments) review completed. These include revefenacin (six), migalastat hydrochloride (three), cupric sulfate (three), ivosidenib (two), upadacitinib (one) and voxelotor (one). Revefenacin is losing its marketing exclusivity this year.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) Our viewIn our last (H1 2022) review of DMF submissions, we had mentioned that less than half of the 350 Type II DMFs filed by the FDA had been reviewed, as the user fee program had not been reauthorized.FDA published the New GDUFA III fee structure at the eleventh hour — on September 30, 2022. GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality and affordable generics.With the GDUFA III, the US government has made clear its intent to lower generic drug prices. In future, more drugs are likely to go off-patent and we are likely to see the number of DMF submissions rise even further.In the second quarter of 2022, FDA resumed unannounced inspections in India. The regulator has also stepped up onsite inspections. FDA wants cheaper drugs, but not at the cost of quality. There are no short-cuts for generic and bulk drug manufacturers wanting to export to the US.(This article has been updated to accurately reflect the information on Metrochem API and MSN Labs.)

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