ANI Pharmaceuticals Inc DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

SPI Pharma has been solving formulation challenges using superior functional materials.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 142 News #PharmaBuzz

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Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
142 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

1 All APIs, 1 USDMF

1 All APIs
1 USDMF

DEVELOPMENTS

60 Drugs in Development

60 Drugs in Development

FINISHED DOSAGE FORMULATIONS

439 FDF Dossiers, 439 FDA Orange Book

439 FDF Dossiers
439 FDA Orange Book

SERVICES

API & Drug Product Development

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API & Drug Product Development
- 1 API Development

INSPECTIONS & REGISTRATIONS

8 FDA, 1 GDUFA

inspections
8 FDA
1 GDUFA

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About

An emerging leader in the specialty pharmaceuticals industry, ANI Pharmaceuticals develops, manufactures and markets top quality prescription pharmaceuticals, made in the U.S.A. In two facilities with combined manufacturing, packaging and laboratory capacity exceeding 170,000 sq. ft., ANI develops and manufactures liquid, powder and oral solid dose products, including those requiring containment. ANI also performs contract ma...

CPhI South East AsiaCPhI South East Asia

Not Confirmed

Not Confirmed

16-18 July, 2025

MITEC, Kuala Lumpur, Malaysia
The Aesthetic ShowThe Aesthetic Show

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Not Confirmed

26-29 June, 2025

Wynn Las Vegas
Specialty & Agro Chemi...Specialty & Agro Chemical

Not Confirmed

Not Confirmed

29 June-01 July, 2025

Savannah, Georgia

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CONTACT DETAILS

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Country

U.S.A

Address

210 Main Street West Baudette, MN 56623

Telephone

+1 302.482.8644 / 218.634.3500

enquiries@pharmacompass.com

Website

https://www.anipharmaceuticals.com/

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INTERVIEW #SpeakPharma

[Sponsored by another company]

Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

Impressions: 1233

VLOG #PharmaReel

[Sponsored by another company]

Providing RSMs & API to Global Pharma Companies

This PharmaReel showcases Allsino Pharmaceutical, a company that provides GMP-certified RSMs and APIs to global pharma companies, specializing in peptides, oligonucleotides, and small molecule CDMO services. Allsino has a presence in the US, EU, China and Japan.

Impressions: 1198

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

J&J’s Intra‑Cellular buyout, BMS’ oncology gambit, Sanofi’s Blueprint acquisition drive mega deals in H1 2025

The pharmaceutical industry has witnessed a wave of mergers, acquisitions, and strategic partnerships so far in the first half (H1) of 2025, with deal values exceeding US$ 170 billion.PharmaCompass’ data shows oncology alone accounted for nearly US$ 47 billion in deal value, followed by US$ 18 billion each in immunology and psychiatry, US$ 17 billion in nutrition/weight loss and US$ 7 billion in neurology.Pharma majors such as Johnson & Johnson and Bristol Myers Squibb led with two deals worth over US$ 10 billion each. Sanofi executed a series of deals in the immunology and neuro-inflammation space. And Eli Lilly stood out for its aggressive dealmaking, which spanned oncology, pain, RNA therapies, and AI-driven oligonucleotides. In all, it signed seven deals worth over US$ 1 billion each. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available)H1 records several mega deals as J&J buys Intra-Cellular, BMS ties up with BioNTech, Sanofi acquires BlueprintJohnson & Johnson dominated headlines with its US$ 14.6 billion acquisition of Intra-Cellular Therapies in January 2025. This marks the largest biopharma deal since Novo Nordisk’s US$ 16.5 billion acquisition of Catalent in February 2024. This acquisition positions J&J as a formidable player in the neuroscience space. Bristol Myers Squibb entered into a US$ 11.1 billion partnership with BioNTech. The deal structure — US$ 3.5 billion in unconditional payments and up to US$ 7.6 billion in milestone payments — demonstrates BMS’ confidence in BNT327, a next-generation bispecific antibody in phase 3 trials for treating extensive stage small cell lung cancer and non-small cell lung cancer.Sanofi acquired Blueprint Medicines for US$ 9.5 billion in order to enhance its rare disease portfolio. The French drugmaker is also creating a comprehensive immunology portfolio. The company signed a US$ 1.9 billion deal for Dren Bio’s DR-0201 bispecific antibody for autoimmune diseases. Sanofi also acquired Vigil Neuroscience for US$ 470 million for its phase 2-ready Alzheimer’s disease candidate. Additionally, the drugmaker secured a US$ 1.84 billion global license agreement with Earendil Labs for two next-generation bispecific antibodies.Pfizer’s US$ 6.05 billion partnership with 3SBio provides it global licensing rights (excluding China) for SSGJ-707, a bispecific antibody currently undergoing multiple clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Obesity gold rush sees Roche, AbbVie, Sciwind ink deals; Novo pledges over US$ 5 bn across three dealsThe obesity therapeutics market has triggered intense competition among pharmaceutical giants. Roche’s US$ 5.3 billion partnership with Zealand Pharma is focused on petrelintide, an amylin analog designed to preserve lean mass better than existing GLP-1-based treatments. The collaboration combines petrelintide with Roche’s dual GLP-1/GIP receptor agonist CT-388, creating a differentiated obesity treatment.Market leader Novo Nordisk has promised over US$ 5 billion across three major obesity deals in 2025. The US$ 2.2 billion Septerna collaboration targets oral small molecule medicines for obesity and cardiometabolic diseases.Novo signed a separate US$ 2 billion agreement with China’s United Biotechnology for UBT251, a triple agonist for GLP-1, GIP, and glucagon receptors in phase 2 clinical development for obesity, type 2 diabetes, and other diseases. The company’s third major deal, a US$ 1 billion partnership with Lexicon Pharmaceuticals, provides it access to LX9851, a molecule in preclinical development for obesity and associated metabolic disorders.Sciwind Biosciences secured a US$ 2.5 billion global licensing and collaboration agreement with Verdiva Bio Limited for the global development and commercialization of a portfolio of metabolic diseases therapies. AbbVie entered the amylin arena through its US$ 2.2 billion Gubra partnership for GUB014295, a candidate in phase 1 trials for treating obesity. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Molecular glue degraders draw investments; Lilly signs seven deals over US$ 1 billion eachMolecular glue degraders have emerged as a transformative therapeutic modality, attracting significant investment across multiple partnerships. AbbVie’s US$ 1.64 billion collaboration with Neomorph leverages the biotech’s leading molecular glue discovery platform for oncology and immunology applications.Genentech’s potential US$ 2.1 billion partnership with Orionis Biosciences focuses on small-molecule monovalent glue medicines for novel and challenging oncology targets. This is the second partnership between the two companies, following their initial 2023 collaboration.Eli Lilly has collaborated with Magnet Biomedicine, utilizing Magnet’s TrueGlue discovery platform for oncology applications. The deal could be worth up to US$ 1.3 billion.Eli Lilly has emerged as one of 2025’s most active dealmakers, with approximately seven deals exceeding US$ 1 billion each. The company’s US$ 2.5 billion Scorpion Therapeutics acquisition provides access to STX-478, an experimental oral therapy in early-stage trials for breast cancer and advanced solid tumors, potentially addressing 30 to 40 percent of hormone-positive breast cancer patients.On June 17, Lilly announced the acquisition of gene-editing startup Verve Therapeutics for US$ 1.3 billion. Lilly’s US$ 1 billion SiteOne acquisition announced in May brings STC-004, a phase 2-ready non-opioid chronic pain treatment to its pipeline. Other partnerships announced by Lilly include a US$ 1.4 billion capsid licensing deal with Sangamo for central nervous system disease genomic medicines and a US$ 1.3 billion collaboration with South Korean company Rznomics for RNA-based hearing loss treatments. Lilly has also strengthened its oligonucleotide pipeline through a potential US$ 1 billion collaboration with Creyon Bio for AI-designed oligonucleotide therapies targeting RNA. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Merck KGaA acquires SpringWorks for US$ 3.9 bn; Novartis buys out Anthos for US$ 3.1 bnAstraZeneca signed a US$ 5.3 billion AI-led research agreement with China’s CSPC Pharmaceuticals Group to advance the discovery of novel oral candidates for immunological diseases. Merck KGaA acquired SpringWorks for US$ 3.9 billion in April, which gave it access to two FDA-approved therapies — Ogsiveo (nirogacestat), the first and only approved therapy for adult patients with progressing desmoid tumors requiring systemic treatment, and Gomekli (mirdametinib), the first and only FDA-approved therapy for adults and children with neurofibromatosis type 1-associated plexiform neurofibromas.Novartis’ US$ 3.1 billion Anthos Therapeutics acquisition centered around abelacimab, a potential first-in-class monoclonal antibody currently in three phase 3 studies for stroke and systemic embolism prevention in atrial fibrillation patients.GSK’s US$ 2 billion acquisition of Boston Pharmaceuticals’ efimosfermin targets steatotic liver disease (fatty liver disease). The medicine is also in clinical development for MASH treatment. GSK’s second major deal involved the US$ 1.15 billion acquisition of US biotech IDRx, strengthening its gastrointestinal cancer portfolio.The pharma industry also drew some private equity interest as Bain Capital acquired Japan’s Mitsubishi Tanabe Pharma from Mitsubishi Chemical Group for US$ 3.3 billion. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Our viewDespite an uncertain geopolitical environment, the year has seen a surge in M&As and dealmaking in the first half of 2025. However, a sizable chunk of the acquisitions were bolt-on transactions, indicating that companies are not ready to take on risks, and are buying out smaller players who strategically fit into their operations. Going forward, there are indications that M&A activity will stay strong throughout 2025.