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    Company profile for Symbiotec Pharmalab

    Symbiotech Pharmalab-PSE
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    Symbiotec Pharmalab Files Papers to Raise Rs 2180 cr via IPO

    22 Dec 2025

    // BIOSPECTRUM

    Symbiotec Pharmalab Annual Report Symbiotec 2024-25

    11 Nov 2025

    // PRESS RELEASE

    Symbiotec Pharmalab plans IPO to boost specialty pharma market

    25 Jun 2025

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    Symbiotec Pharmalab

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    Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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    About

    Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovation, it operates a state-of-the-art facility inaugurated in 2004. Certified by WHO-GMP, ISO, US FDA, and EU GMP, Symbiotec is a trusted provider known for quality, adaptability, efficiency, and competitive pricing in global healthcare. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    385, Pigdamber, Rau, Indore, MP, 453331
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    +91 7316676405
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    symbiotec@symbiotec.in
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    VLOG #PharmaReel

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    ReelPharmaPurity Meets PurposePurity Meets Purpose

    Purity Meets Purpose
    Purity Meets Purpose

    reelPurity Meets Purpose

    This PharmaReel highlights Symbiotec, a leading API manufacturer, specializing in corticosteroids and steroid hormones, with expertise in fermentation, and biotransformation, certified by US FDA and EDQM, and known for quality, adaptability, efficiency, and competitive pricing in global healthcare.

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2025

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    API Product List 2025

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    Intermediates Product List 2025

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    Products Under Development 2025

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    GMP Certificate 2024

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    Regulatory Filing

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    DATA COMPILATION #PharmaFlow

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    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA 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.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    NEWS #PharmaBuzz

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    Symbiotec Pharmalab Files Papers to Raise Rs 2180 cr via IPO
    Symbiotec Pharmalab Files Papers to Raise Rs 2180 cr via IPO

    22 Dec 2025

    // BIOSPECTRUM

    https://www.biospectrumindia.com/news/16/27105/symbiotec-pharmalab-files-drhp-with-sebi-for-ipo-aggregating-upto-rs-2180-cr.html

    BIOSPECTRUM
    22 Dec 2025
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    Symbiotec Pharmalab Annual Report Symbiotec 2024-25
    Symbiotec Pharmalab Annual Report Symbiotec 2024-25

    11 Nov 2025

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    https://symb.connectbizora.com/uploads/1767168398145-992951151.pdf

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    11 Nov 2025
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    Symbiotec Pharmalab plans IPO to boost specialty pharma market
    Symbiotec Pharmalab plans IPO to boost specialty pharma market

    25 Jun 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/markets/ipos/fpos/symbiotec-pharmalab-plans-ipo-to-boost-specialty-pharma-market/articleshow/122058256.cms?from=mdr

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    25 Jun 2025
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    Symbiotec Pharmalab Annual Report Symbiotec 2023-24
    Symbiotec Pharmalab Annual Report Symbiotec 2023-24

    28 May 2025

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    https://www.symbiotec.in/wp-content/uploads/2024/11/ESG-Report-2023-24-Signed.pdf

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    28 May 2025
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    Symbiotec eyes IPO to give exit to PE investors
    Symbiotec eyes IPO to give exit to PE investors

    17 Oct 2024

    // VCCIRCLE

    https://www.vccircle.com/symbioteceyes-ipo-to-give-exit-to-pe-investors-can-it-command-a-high-valuation

    VCCIRCLE
    17 Oct 2024
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    Symbiotec Pharmalab Annual Report Symbiotec 2022-23
    Symbiotec Pharmalab Annual Report Symbiotec 2022-23

    19 Jan 2024

    // PRESS RELEASE

    https://symb.connectbizora.com/uploads/1767168978578-560500724.pdf

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    19 Jan 2024
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    ALL APIs

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    01

    Clobetasol Propionate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Booth #5F3
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    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-11

    Pay. Date : 2012-12-31

    DMF Number : 20821

    Submission : 2007-08-29

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 229MF10086

    Registrant's Address : 385/2, Pigdamber, Off. A. B. Road, Rau, Indore 453331 (M.P.) India

    Initial Date of Registration : 2017-04-25

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0006

    Start Marketing Date : 2017-12-13

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : GlaxoSmithKline Inc.

    Registration Date : 2021-11-10

    Registration Number : 20121126-93-E-103-07(A)

    Manufacturer Name : Symbiotec Pharmalab Pvt. Limited

    Manufacturer Address : 385/2 Gram Pigdamber, Near Hotel Mashal, Off AB Road, Rau, Indore-453 331 (MP) India

     VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    02

    Betamethasone

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-13

    Pay. Date : 2014-04-29

    DMF Number : 25197

    Submission : 2011-08-10

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0030

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    03

    Betamethasone Dipropionate

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-02

    Pay. Date : 2016-02-12

    DMF Number : 25798

    Submission : 2012-02-16

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0028

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    04

    Betamethasone Valerate

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-01

    Pay. Date : 2014-04-29

    DMF Number : 22062

    Submission : 2008-10-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0005

    Start Marketing Date : 2017-12-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    05

    Deflazacort

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-11-05

    Pay. Date : 2021-11-02

    DMF Number : 24691

    Submission : 2011-03-02

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0027

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    06

    Desoximetasone

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-23

    Pay. Date : 2012-12-31

    DMF Number : 22400

    Submission : 2009-01-12

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0008

    Start Marketing Date : 2010-02-17

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2024-07-17

    Registration Number : 20240717-211-J-1663

    Manufacturer Name : Symbiotec Pharmalab Pvt. Limited

    Manufacturer Address : 385/2 Gram Pigdamber, Near Hotel Mashal, Off AB Road, Rau, Indore-453 331 (MP) India

     VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    07

    Methylprednisolone

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
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    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-21

    Pay. Date : 2013-12-17

    DMF Number : 27783

    Submission : 2013-11-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0029

    Start Marketing Date : 2011-08-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Daeshin Muyak Co., Ltd.

    Registration Date : 2023-01-11

    Registration Number : 20210715-209-J-1022(2)

    Manufacturer Name : Symbiotec Pharmalab Private Limited

    Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. Dhar - 454 774(MP), India

     VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    08

    Mometasone Furoate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-01

    Pay. Date : 2014-04-29

    DMF Number : 20684

    Submission : 2007-07-12

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0002

    Start Marketing Date : 2017-12-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    09

    Prednisolone

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24630

    Submission : 2011-02-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0052

    Start Marketing Date : 2020-09-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Symbiotec Pharmalab

    10

    Prednisolone Sodium Phosphate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-10

    Pay. Date : 2016-05-27

    DMF Number : 23899

    Submission : 2010-06-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 22552-0051

    Start Marketing Date : 2020-05-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
    Symbiotec Pharmalab
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    USDMF

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    01

    16a-hydroxy Prednisolone (intermedia...

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29224

    Submission : 2015-03-30

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    17-a Hydroxyprogesterone (intermedia...

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29030

    Submission : 2015-01-20

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Beclomethasone Dipropionate Usp (mic...

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28137

    Submission : 2014-03-20

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Betamethasone Acetate Usp

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-10-25

    Pay. Date : 2023-10-05

    DMF Number : 36086

    Submission : 2022-07-21

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Betamethasone Dipropionate

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-06-02

    Pay. Date : 2016-02-12

    DMF Number : 25798

    Submission : 2012-02-16

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Betamethasone Sodium Phosphate Usp

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-10-25

    Pay. Date : 2023-10-03

    DMF Number : 37466

    Submission : 2022-09-09

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Betamethasone Valerate, Usp (microni...

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-05-01

    Pay. Date : 2014-04-29

    DMF Number : 22062

    Submission : 2008-10-07

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Betamethasone, Usp (micronized)

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-10-13

    Pay. Date : 2014-04-29

    DMF Number : 25197

    Submission : 2011-08-10

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Clobetasol Propionate Usp

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-04-11

    Pay. Date : 2012-12-31

    DMF Number : 20821

    Submission : 2007-08-29

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Deflazacort Micronized

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-11-05

    Pay. Date : 2021-11-02

    DMF Number : 24691

    Submission : 2011-03-02

    Status : Active

    Type : II

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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    EU WC

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    01

    Abiraterone Acetate USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-08-31

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0162Amended

    Address of the Firm : Plot No. 5,6,7 & 8, Special Ec...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Abiraterone Acetate USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161A2

    Address of the Firm : 385/2, Gram Pigdamber, Rau, In...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Abiraterone Acetate USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-07-23

    Valid Till : 2025-02-07

    Written Confirmation Number : WC-0162n

    Address of the Firm : Plot No-5,6,7 & 8, Special Eco...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    04

    Beclomethasone Dipropionate ...

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm : 385/2, Gram Pigdamber, Rau , I...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Beclomethasone Dipropionate ...

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161n

    Address of the Firm : PLOT NO.385/2, Gram Pigdamber,...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Betamethasone BP/EP/USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2025-09-03

    Valid Till : 2028-09-02

    Written Confirmation Number : WC-0161

    Address of the Firm : 385/2, Gram Pigdamber, Rau , I...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Betamethasone BP/EP/USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161n

    Address of the Firm : PLOT NO.385/2, Gram Pigdamber,...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Betamethasone BP/EP/USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161A2

    Address of the Firm : 385/2, Gram Pigdamber, Rau, In...

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    09

    Betamethasone BP/EP/USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-08-31

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0162Amended

    Address of the Firm : Plot No. 5,6,7 & 8, Special Ec...

    Symbiotec Pharmalab

    Product
    Web Link

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    #PipelineProspector

    Market
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    10

    Betamethasone BP/EP/USP

    India
    arrow
    CPhI Milan
    Booth #5F3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

    Symbiotec Pharmalab

    Date of Issue : 2022-07-23

    Valid Till : 2025-02-07

    Written Confirmation Number : WC-0162n

    Address of the Firm : Plot No-5,6,7 & 8, Special Eco...

    Symbiotec Pharmalab

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    KEY PRODUCTS

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    Services

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    API Manufacturing

    Discover their expertise for : API Manufacturing

    Inspections and registrations

    Check the inspections & registration from this company

    FDA

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    01

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-09-30

    Symbiotec Pharmalab

    City : Pithampur

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-09-30

    Symbiotec Pharmalab

    Product
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    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-22

    Symbiotec Pharmalab

    City : Mhow

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-22

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
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    Data Compilation
    #PharmaFlow

    03

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-09-13

    Symbiotec Pharmalab

    City : Mhow

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-09-13

    Symbiotec Pharmalab

    Product
    Web Link

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    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-12

    Symbiotec Pharmalab

    City : Mhow

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-12

    Symbiotec Pharmalab

    Product
    Web Link

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    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-12

    Symbiotec Pharmalab

    City : Mhow

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-12

    Symbiotec Pharmalab

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-05

    Symbiotec Pharmalab

    City : Pithampur

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-05

    Symbiotec Pharmalab

    Product
    Web Link

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    #PipelineProspector

    Data Compilation
    #PharmaFlow

    07

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-05

    Symbiotec Pharmalab

    City : Pithampur

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-05-05

    Symbiotec Pharmalab

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    08

    FDA Audited

    USA
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    CPhI Milan
    Booth #5F3

    District Decision : No Action Indicated

    Inspection End Date : 2015-04-10

    Symbiotec Pharmalab

    City : Pithampur

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2015-04-10

    Symbiotec Pharmalab

    Product
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    09

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #5F3

    District Decision : No Action Indicated

    Inspection End Date : 2015-04-10

    Symbiotec Pharmalab

    City : Pithampur

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-04-10

    Symbiotec Pharmalab

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    10

    FDA Audited

    USA
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    CPhI Milan
    Booth #5F3

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-25

    Symbiotec Pharmalab

    City : Mhow

    State :

    Country/Area : India

    Zip :

    District :

    Center :

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-25

    Symbiotec Pharmalab

    Product
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    #PipelineProspector

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    #PharmaFlow

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    01

    GMP Certified

    EU
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    CPhI Milan
    Booth #5F3

    Symbiotec Pharmalab

    Type : GMP Certificates

    Number : DE_BY_04_GM...

    EudraGMDP Key : 167889

    Country : India

    Issue Date : 2024-02-22

    Post Code :

    NCA Ref : 170891125836...

    City : Pithampur

    Symbiotec Pharmalab

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    02

    GMP Certified

    EU
    arrow
    CPhI Milan
    Booth #5F3

    Symbiotec Pharmalab

    Type : GMP Certificates

    Number : DE_BY_04_GM...

    EudraGMDP Key : 160829

    Country : India

    Issue Date : 2023-04-21

    Post Code :

    NCA Ref : PL0585

    City : Indore

    Symbiotec Pharmalab

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