Company profile for Granules India Limited

PharmaCompass

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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About

Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value chain—APIs, Formulation Intermediates, & Formulations. With 10 facilities (8 in India, 2 in the US) approved by US FDA, EDQM, EU GMP, WHO GMP, & more, its products reach 300+ customers in 80+ countries. Granules has offices in India, the US, & the UK, ensuring a strong global presence.

Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.

CONTACT DETAILS

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Country
Country
India
Address
Address
2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500 081 (TG)
Telephone
Telephone
+91 4069043500
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YouTube
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CORPORATE CONTENT #SupplierSpotlight

    https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-48360.pdf

    https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-37474.pdf

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DATA COMPILATION #PharmaFlow

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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.   

Impressions: 7112

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

NEWS #PharmaBuzz

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https://www.indianpharmapost.com/news/granules-india-acquires-swiss-senn-chemicals-to-foray-into-peptide-and-cdmo-business-16813

INDPHARMAPOST
22 Feb 2025

https://granulesindia.com/wp-content/uploads/2025/01/Granules-Strengthens-ADHD-Portfolio-with-FDA-Approval-for-Lisdexamfetamine-Dimesylate-Capsules.pdf

PRESS RELEASE
30 Jan 2025

https://granulesindia.com/wp-content/uploads/2025/01/Press-Release-Q3-FY25.pdf

PRESS RELEASE
27 Jan 2025

https://www.business-standard.com/companies/news/granules-india-expects-fda-nod-for-drug-from-gagillapur-facility-by-fy26-124122900434_1.html

BUSINESS STD
29 Dec 2024

https://granulesindia.com/wp-content/uploads/2024/12/Granules-India-Limited-Announces-FDA-Approval-for-ADHD-Treatment-Addressing-Drug-Shortages-in-the-U.S.pdf

PRESS RELEASE
17 Dec 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219258

FDA
16 Dec 2024

USDMF

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FDF Dossiers

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01

Brand Name : ACETAMINOPHEN

Granules India Limited

Dosage Form : TABLET, EXTENDED RELEASE...

Brand Name : ACETAMINOPHEN

Dosage Strength : 650MG

Packaging :

Approval Date : 2019-04-16

Application Number : 211544

Regulatory Info : OTC

Registration Country : USA

Granules India

02

Brand Name : N/A

Granules India Limited

Dosage Form : Extended Release Tablet

Brand Name :

Dosage Strength : 650MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US, CA

Registration Country : India

Granules India

03

Brand Name : N/A

Granules India Limited

Dosage Form : Immediate Release Tablet

Brand Name :

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, UK, EU, ROW, SA

Registration Country : India

Granules India

04

Brand Name : ARTHRITIS PAIN RELIE...

Granules India Limited

Dosage Form : TABLET (EXTENDED-RELEASE...

Brand Name : ARTHRITIS PAIN RELIEF

Dosage Strength : 650MG

Packaging :

Approval Date :

Application Number : 2519631

Regulatory Info :

Registration Country : Canada

Granules India

05

Brand Name : N/A

Granules India Limited

Dosage Form : Rapid Release Gelcaps

Brand Name :

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

06

Brand Name : N/A

Granules India Limited

Dosage Form : Immediate Release Tablet

Brand Name :

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, EU

Registration Country : India

Granules India

07

Brand Name : ACETAMINOPHEN, ASPIR...

Granules India Limited

Dosage Form : TABLET;ORAL

Brand Name : ACETAMINOPHEN, ASPIRIN AN...

Dosage Strength : 250MG;250MG;65MG

Packaging :

Approval Date : 2021-02-23

Application Number : 214039

Regulatory Info : OTC

Registration Country : USA

Granules India

08

Brand Name : N/A

Granules India Limited

Dosage Form : Immediate Release Tablet

Brand Name :

Dosage Strength : 250MG; 250MG; 65MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

09

Brand Name : BUTALBITAL AND ACETA...

Granules India Limited

Dosage Form : CAPSULE;ORAL

Brand Name : BUTALBITAL AND ACETAMINOP...

Dosage Strength : 300MG;50MG

Packaging :

Approval Date : 2019-11-22

Application Number : 213115

Regulatory Info : RX

Registration Country : USA

Granules India

10

Brand Name : N/A

Granules India Limited

Dosage Form : Immediate Release Capsul...

Brand Name :

Dosage Strength : 300MG; 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India
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FDA Orange Book

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KEY PRODUCTS

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Inspections and registrations

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FDA

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01

FDA Audited

USA

Granules India Limited

City : Qutbullapur Mandal, Ranga...

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-03-13

Granules India

02

FDA Audited

USA

Granules India Limited

City : Bonthapally, Medak Distri...

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-06-13

Granules India

03

FDA Audited

USA

Granules India Limited

City : Visakhapatnam

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-06-14

Granules India

04

FDA Audited

USA

Granules India Limited

City : Hyderabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-05-08

Granules India

05

FDA Audited

USA

Granules India Limited

City : Qutbullapur Mandal, Ranga...

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-09-13

Granules India

06

FDA Audited

USA

Granules India Limited

City : Bonthapally, Medak Distri...

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-11-22

Granules India

07

FDA Audited

USA

Granules India Limited

City : Qutbullapur Mandal, Ranga...

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-11-12

Granules India

08

FDA Audited

USA

Granules India Limited

City : Hyderabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-03-06

Granules India
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EDQM

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01

GMP Certified

EU

Granules India Limited

Type : GMP Certificates

Number : FT022/MH/00...

EudraGMDP Key : 40343

Country : India

Issue Date : 2017-02-24

Post Code : 500043

NCA Ref : FT022

City : Ranga Reddy District

Granules India

02

GMP Certified

EU

Granules India Limited

Type : GMP Certificates

Number : FT052/S1/MH...

EudraGMDP Key : 31856

Country : India

Issue Date : 2015-10-26

Post Code : 500 055

NCA Ref : 104621298632...

City : Hyderabad

Granules India

03

GMP Certified

EU

Granules India Limited

Type : GMP Certificates

Number : HMP/PT/221/...

EudraGMDP Key : 28131

Country : India

Issue Date : 2014-11-19

Post Code : 500055

NCA Ref : A0372917466

City : HYDERABAD, ANDHRA PRADE...

Granules India

04

GMP Certified

EU

Granules India Limited

Type : GMP Certificates

Number : FI21/01/201...

EudraGMDP Key : 25980

Country : India

Issue Date : 2014-10-27

Post Code : 502313

NCA Ref : 104721298997...

City : Medak District

Granules India

05

GMP Certified

EU

Granules India Limited

Type : GMP Certificates

Number : FI22/01/201...

EudraGMDP Key : 21875

Country : India

Issue Date : 2013-12-16

Post Code : 500 043

NCA Ref : 104621298630...

City : Quthbullapur Mandal, Ra...

Granules India

06

GMP Certified

EU

Granules India Limited

Type : GMP Certificates

Number : FI21/01/201...

EudraGMDP Key : 21874

Country : India

Issue Date : 2013-12-16

Post Code : 502313

NCA Ref : 1.04721299e+...

City : Medak District

Granules India
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ABOUT THIS PAGE

Contact Granules India Limited and get a quotation

Granules India Limited is a supplier offers 44 products (APIs, Excipients or Intermediates).

Find a price of Metformin bulk with DMF, CEP, JDMF, WC offered by Granules India Limited

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Find a price of Pantoprazole Sodium bulk with DMF, CEP offered by Granules India Limited

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Find a price of Sorafenib bulk with DMF, CEP offered by Granules India Limited

Find a price of Bupropion Hydrochloride bulk with DMF offered by Granules India Limited

Find a price of Dapagliflozin bulk with DMF offered by Granules India Limited

Find a price of Dasatinib bulk with DMF offered by Granules India Limited

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Find a price of Nilotinib bulk with DMF offered by Granules India Limited

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