Company profile for Alchem International Private Ltd

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Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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About

Alchem International, established in 1935, is a pioneer in phytochemicals, providing plant-derived active pharmaceutical ingredients to the pharmaceutical, cosmetic and nutraceutical industries. With over 75 years of experience, Alchem has established a global presence, selling its products in more than 35 countries. Alchem has three manufacturing sites spread across 62 acres in India and four international divisions with offices in India, Europe, Hong Kong and the US. Alchem has two divisions – Phytoceuticals and EpiQue – that provide healthcare and cosmetic products to the Indian market and employs over 1,000 people worldwide.

CONTACT DETAILS

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Country
Country
India
Address
Address
201, Empire Plaza, Mehrauli - Gurgaon Road, Sultanpur, New Delhi-110 030
Telephone
Telephone
+91 1126809882
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Twitter

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CORPORATE CONTENT #SupplierSpotlight

    https://www.pharmacompass.com/pdf/party/content/alchem-international-private-ltd-party-content-75699.pdf

    https://www.pharmacompass.com/pdf/party/content/alchem-international-private-ltd-party-content-1604146223.pdf

    https://www.pharmacompass.com/pdf/party/content/alchem-international-private-ltd-party-content-1633932351.pdf

DATA COMPILATION #PharmaFlow

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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. 

Impressions: 11483

https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

#PharmaFlow by PHARMACOMPASS
21 Nov 2024

NEWS #PharmaBuzz

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https://www.pharmacompass.com/pdf/news/prof-dr-serhat-nal-tells-things-to-consider-in-the-influenza-covid-spiral-55169.pdf

WINALLY
17 Dec 2022

https://www.prnewswire.com/news-releases/sales-focus-inc-expands-sales-outsourcing-services-into-the-healthcare-industry-with-six-new-clients-301664530.html

PR NEWSWIRE
01 Nov 2022

https://www.phillyvoice.com/alchem-life-usa-and-stevenson-advocacy-llc-donation-immunity-boosting-supplement-0599962/

PHILLYVOICE
14 Oct 2021

https://health.economictimes.indiatimes.com/news/pharma/aiims-patna-confirms-efficacy-of-alchemlifes-phytorelief-to-combat-moderate-cases-of-covid-19/83401825

ECONOMICTIMES
10 Jun 2021

https://www.prnewswire.com/news-releases/university-researcher-analyzes-herbal-supplements-potential-against-covid-19-301233869.html

PR NEWSWIRE
23 Feb 2021

https://www.prnewswire.com/in/news-releases/alchemlife-s-phytorelief-cc-being-used-in-eminent-indian-hospitals-as-an-immunity-booster-845237627.html

PR NEWSWIRE
08 Dec 2020

01

Digoxin

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

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CEP/COS arrow-down JDMF arrow-down EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
Alchem

02

Atropine Sulfate

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

USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
Alchem

03

Colchicine

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

USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF CN arrow-down AUDIT
Alchem

04

Hyoscine Butyl Bromide

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

USDMF CEP/COS arrow-down JDMF arrow-down EU-WCarrow-down NDC KDMF arrow-down VMF Others AUDIT
Alchem

05

Nicotine

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

USDMF arrow-down CEP/COS arrow-down JDMF EU-WCarrow-down NDC arrow-down KDMF VMF TPMF arrow-down AUDIT
Alchem

06

Enoxolone

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

USDMF CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
Alchem

07

Methscopolamine Bromide

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

USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
Alchem

08

Scopolamine

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

USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
Alchem

09

Scopolamine Hydrobromide

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

USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC arrow-down KDMF VMF ASMF arrow-down AUDIT
Alchem

10

Thiocolchicoside

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

USDMF CEP/COS arrow-down JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
Alchem
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USDMF

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NDC API

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01

02

Alchem International Private Ltd

NDC Package Code : 55742-127

Start Marketing Date : 2016-12-23

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

Alchem

03

Alchem International Private Ltd

NDC Package Code : 55742-123

Start Marketing Date : 2011-02-02

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

Alchem

04

06

Alchem International Private Ltd

NDC Package Code : 55742-128

Start Marketing Date : 2016-12-23

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

Alchem

07

08

09

Alchem International Private Ltd

NDC Package Code : 55742-126

Start Marketing Date : 2014-09-15

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

Alchem
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KEY PRODUCTS

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TOP RANKED SUPPLIER FOR:

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Services

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KEY SERVICES

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TOP RANKED SUPPLIER FOR:

Extracts from Fresh & Dried Plants
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REF. STANDARDS & IMPURITIES

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Inspections and registrations

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FDA

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01

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-07-22

Alchem International Private Ltd

City : Neemrana, Alwar

State : -

Country/Area : India

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-07-22

Alchem

02

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-04-01

Alchem International Private Ltd

City : Panipat, Hariyana

State :

Country/Area : IN

Zip :

District : ORA

Center : CFSAN

Project Area : Food Composition, Standards, Lab...

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-04-01

Alchem

03

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-04-01

Alchem International Private Ltd

City : Panipat, Hariyana

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-04-01

Alchem

04

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-04-01

Alchem International Private Ltd

City : Faridabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-04-01

Alchem

05

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-11

Alchem International Private Ltd

City : Faridabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CFSAN

Project Area : Food Composition, Standards, Lab...

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-11

Alchem

06

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-11

Alchem International Private Ltd

City : Faridabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-07-11

Alchem

07

FDA Audited

USA

Alchem International Private Ltd

City : Faridabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-10-08

Alchem

08

FDA Audited

USA

Alchem International Private Ltd

City : Neemrana, Alwar

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2016-08-04

Alchem

09

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-09-15

Alchem International Private Ltd

City : Faridabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-09-15

Alchem

10

FDA Audited

USA

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-09-06

Alchem International Private Ltd

City : Faridabad

State :

Country/Area : IN

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-09-06

Alchem
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EDQM

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01

GMP Certified

EU

Alchem International Private Ltd

Type : GMP Certificates

Number : 17MPP004HPT...

EudraGMDP Key : 41174

Country : India

Issue Date : 2017-04-25

Post Code : 121 004

NCA Ref : A049 9337 76...

City : Faridabad

Alchem

02

GMP Certified

EU

Alchem International Private Ltd

Type : GMP Certificates

Number : 2008/HMP/PT...

EudraGMDP Key : 4589

Country : India

Issue Date : 2008-04-17

Post Code : 121 004

NCA Ref : A049 9337 76...

City : Faridabad

Alchem
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ABOUT THIS PAGE

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Alchem International Private Ltd is a supplier offers 49 products (APIs, Excipients or Intermediates).

Find a price of Digoxin bulk with DMF, CEP, JDMF, WC offered by Alchem International Private Ltd

Find a price of Atropine Sulfate bulk with DMF, CEP, WC offered by Alchem International Private Ltd

Find a price of Colchicine bulk with DMF, CEP, WC offered by Alchem International Private Ltd

Find a price of Hyoscine Butyl Bromide bulk with CEP, JDMF, WC offered by Alchem International Private Ltd

Find a price of Nicotine bulk with DMF, CEP, WC offered by Alchem International Private Ltd

Find a price of Enoxolone bulk with CEP, WC offered by Alchem International Private Ltd

Find a price of Methscopolamine Bromide bulk with DMF, WC offered by Alchem International Private Ltd

Find a price of Scopolamine bulk with DMF, WC offered by Alchem International Private Ltd

Find a price of Scopolamine Hydrobromide bulk with DMF, WC offered by Alchem International Private Ltd

Find a price of Thiocolchicoside bulk with CEP, WC offered by Alchem International Private Ltd

Find a price of 10-Deacetylbaccatin- III bulk with DMF offered by Alchem International Private Ltd

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