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    September is Gynecologic Cancer Awareness Month

    07 Sep 2022

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    Clay Ganesha Idols Distributed at Lee Pharma Units

    31 Aug 2022

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    Lee Pharma celebrated the 76th Independence Day

    16 Aug 2022

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    Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

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    Lee Pharma Ltd, established in 1997, is a research-driven pharmaceutical company focused on developing, synthesizing, and commercializing high-quality APIs, intermediates, and finished formulations. We manufacture APIs, pellets, granules, and finished dosage forms using innovative, cost-effective processes. Our world-class manufacturing facilities are certified with USFDA, EU GMP, WHO GMP, ISO 9001:2008, and ISO 14001:2004, meeting the highest international standards. With a commitment to excellence, global reach, and consistent regulatory compliance, we serve healthcare markets across more than 50 countries.

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    SY. No. : 257 & 258/1, Door No : 11-6/56-C, Opp : IDPL Factory, Moosapet, Bala...
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    Product List 2025

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    GMP Certificate 2025

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    DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions

    DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions

    The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.
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    15 May 2025
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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
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    September is Gynecologic Cancer Awareness Month
    September is Gynecologic Cancer Awareness Month

    07 Sep 2022

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    https://www.leepharma.com/post/september-is-gynecologic-cancer-awareness-month-what-everyone-should-know

    PRESS RELEASE
    07 Sep 2022
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    Clay Ganesha Idols Distributed at Lee Pharma Units
    Clay Ganesha Idols Distributed at Lee Pharma Units

    31 Aug 2022

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    https://www.leepharma.com/post/clay-ganesha-idols-distributed-at-lee-pharma-units-to-protect-the-environment

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    31 Aug 2022
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    Lee Pharma celebrated the 76th Independence Day
    Lee Pharma celebrated the 76th Independence Day

    16 Aug 2022

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    https://www.leepharma.com/post/76th-independence-day-celebrated-with-patriotic-fervour-and-colour

    PRESS RELEASE
    16 Aug 2022
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    Meno-D, A Novel Formulation For The Treatment Of PCOS.
    Meno-D, A Novel Formulation For The Treatment Of PCOS.

    10 Aug 2022

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    https://www.leepharma.com/post/meno-d-a-novel-formulation-for-the-treatment-of-pcos

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    10 Aug 2022
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    Menocycle Softgel Capsule launched
    Menocycle Softgel Capsule launched

    01 Apr 2022

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    https://www.leepharma.com/post/menocycle-softgel-capsule-launched

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    01 Apr 2022
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    Lee Health develops Enzymeact to treat digestive disorders
    Lee Health develops Enzymeact to treat digestive disorders

    11 Nov 2021

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    https://www.leepharma.com/post/lee-health-develops-enzymeact-to-treat-digestive-disorders

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    11 Nov 2021
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    Drugs in Development

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    Virtual BoothLee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

    Hyderabad Pharma Firm Gets UAE Nod to Market Joint Support Supplement

    Details:

    Smoothwalk Tablet is a dietary supplement containing collagen II and glycosaminoglycans (GAG) as its main constituents, used as a preventive treatment for the arthritis patients.


    Lead Product(s): Collagen Type II,Glucosamine Hydrochloride,Curcumin

    Therapeutic Area: Immunology Brand Name: Smoothwalk

    Study Phase: Approved FDFProduct Type: Protein

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 04, 2023

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    Lee Pharma

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    CPhI WW Frankfurt
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    Lead Product(s) : Collagen Type II,Glucosamine Hydrochloride,Curcumin

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Hyderabad Pharma Firm Gets UAE Nod to Market Joint Support Supplement

    Details : Smoothwalk Tablet is a dietary supplement containing collagen II and glycosaminoglycans (GAG) as its main constituents, used as a preventive treatment for the arthritis patients.

    Product Name : Smoothwalk

    Product Type : Protein

    Upfront Cash : Inapplicable

    November 04, 2023

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    Meno-D, a Novel Formulation for The Treatment of Pcos

    Details:

    Myo-Inositol is a sugar-alcohol compound that acts to regulate a number of hormones in the body, used for patients with Polycystic Ovarian Syndrome.


    Lead Product(s): Inositol,Metformin

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Meno-D

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 09, 2022

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    Lee Pharma

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    Virtual BoothLee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

    Lead Product(s) : Inositol,Metformin

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Meno-D, a Novel Formulation for The Treatment of Pcos

    Details : Myo-Inositol is a sugar-alcohol compound that acts to regulate a number of hormones in the body, used for patients with Polycystic Ovarian Syndrome.

    Product Name : Meno-D

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    August 09, 2022

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    Virtual BoothLee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

    Lee Pharma Develops Natural Product for Post Viral Infections Like Coronavirus

    Details:

    Actokin is a blend of potent nutraceutical ingredients like collagen, curcumin complex, and boswellia serrata extract, used for post viral infections symptoms.


    Lead Product(s): Collagen,Curcumin,Boswellia Serrata Extract

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Actokin

    Study Phase: Approved FDFProduct Type: Protein

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 28, 2021

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    Lee Pharma

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    Virtual BoothLee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

    Lead Product(s) : Collagen,Curcumin,Boswellia Serrata Extract

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lee Pharma Develops Natural Product for Post Viral Infections Like Coronavirus

    Details : Actokin is a blend of potent nutraceutical ingredients like collagen, curcumin complex, and boswellia serrata extract, used for post viral infections symptoms.

    Product Name : Actokin

    Product Type : Protein

    Upfront Cash : Inapplicable

    December 28, 2021

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    Lee Health Unveils Supplement for Spine Disorders

    Details:

    Spinocart is a dietary supplement designed to support spinal health and address issues related to the spine and intervertebral discs.


    Lead Product(s): Collagen Type II,Glucosamine,Curcumin

    Therapeutic Area: Neurology Brand Name: Spinocart

    Study Phase: Approved FDFProduct Type: Protein

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 03, 2021

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    Lee Pharma

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    Booth #11.1C68
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    Virtual BoothLee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

    Lead Product(s) : Collagen Type II,Glucosamine,Curcumin

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lee Health Unveils Supplement for Spine Disorders

    Details : Spinocart is a dietary supplement designed to support spinal health and address issues related to the spine and intervertebral discs.

    Product Name : Spinocart

    Product Type : Protein

    Upfront Cash : Inapplicable

    December 03, 2021

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    Lee Health Develops Enzymeact to Treat Digestive Disorders

    Details:

    Enzymeact is a unique pancreatic enzyme blend, available in the form of delayed release capsules, which is indicated for the treatment of digestive disorders.


    Lead Product(s): Amylase,Protease,Lipase

    Therapeutic Area: Gastroenterology Brand Name: Enzymeact

    Study Phase: Approved FDFProduct Type: Enzyme

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 11, 2021

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    Lee Pharma

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    Virtual BoothLee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

    Lead Product(s) : Amylase,Protease,Lipase

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lee Health Develops Enzymeact to Treat Digestive Disorders

    Details : Enzymeact is a unique pancreatic enzyme blend, available in the form of delayed release capsules, which is indicated for the treatment of digestive disorders.

    Product Name : Enzymeact

    Product Type : Enzyme

    Upfront Cash : Inapplicable

    November 11, 2021

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    Lee Health Launches 'smoothwalk' Tablets for Osteoarthritis

    Details:

    Smoothwalk Tablet is a dietary supplement containing collagen II and glycosaminoglycans (GAG) as its main constituents, used as a preventive treatment for the Osteoarthritis patients.


    Lead Product(s): Collagen Type II,Glucosamine Hydrochloride,Curcumin

    Therapeutic Area: Musculoskeletal Brand Name: Smoothwalk

    Study Phase: Approved FDFProduct Type: Protein

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 01, 2021

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    Lee Pharma

    India
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    CPhI WW Frankfurt
    Booth #11.1C68
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    Virtual BoothLee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.

    Lead Product(s) : Collagen Type II,Glucosamine Hydrochloride,Curcumin

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lee Health Launches 'smoothwalk' Tablets for Osteoarthritis

    Details : Smoothwalk Tablet is a dietary supplement containing collagen II and glycosaminoglycans (GAG) as its main constituents, used as a preventive treatment for the Osteoarthritis patients.

    Product Name : Smoothwalk

    Product Type : Protein

    Upfront Cash : Inapplicable

    July 01, 2021

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    Lee Pharma is a supplier offers 85 products (APIs, Excipients or Intermediates).

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