Pharmaceutical Manufacturer

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Overview

We use our world-class expertise and modern manufacturing infrastructure to develop APIs, intermediates and xanthine derivatives for the pharmaceutical and food/beverages industry. We have our own backward-integrated intermediaries for most of the APIs that are manufactured. Our products are exported to regulated markets across the globe, including the US, and several countries in the European Union and Japan. We have established a Custom Synthesis division to manufacture pharmaceutical intermediates to meet the requirements of various Indian and international customers.

Our active pharmaceutical ingredients (API) manufacturing facility is US FDA and EU GMP-accredited, with dedicated production blocks for steroids and oncological APIs.

We sustain our leadership position because of a robust approach of backward integration. We manufacture the key raw materials for our products in the API segment, which helps us to sustain our leadership position.

We have some dedicated, world class manufacturing facilities for Xanthine derivatives with a mammoth capacity for its flagship product — Caffeine (3600 MT capacity per annum).

We are also the preferred partner in the regulated markets since we provide regulatory documentation and IPR support for global markets (17 CEPs and 26 USDMFs).

AIL’s Intermediates division lays emphasis on tailored process development, scale-up, and exclusive manufacturing. These services are provided under strict Intellectual Property Protection guarded by confidentiality agreements with our clients. The goal is to provide a reliable and strong platform to our customers, enabling them to accelerate their NCE & API development programme, efficiently and in a cost-effective manner.

The xanthine division at Aarti has expertise for manufacturing various derivatives. These include caffeine theophylline anhydrous, aminophylline, etophylline, theobromine, etc. These derivatives are used in beverages, nutraceuticals and pharmaceuticals. Two manufacturing facilities are dedicated to manufacturing xanthine derivatives and have obtained star certifications such as Star Kosher, Hazard Analysis Critical Control Point (HACCP) and GMP for manufacturing and testing.

Manufacturing Units

AARTI INDUSTRIES LIMITED - UNIT I – DOMBIVLI, MAHARASHTRA

The facility specialises in the manufacture of APIs.

It is aligned with the R&D of Autoclave, Flow reactors, RBF and other equipment, with capability of approximately 234 Li. The R&D facility has a workforce of 44 dedicated employees.

This unit is capable of handling the following reactions:

  • Asymmetric Hydrogenation
  • Darzens Glycidic Ester Condensation
  • Butyl Lithium Reaction
  • Hetero Diels Alder Reaction
  • Cyclopropane Chemistry
  • Purine Chemistry
  • Catalytic Hydrogenation
  • Pyrrole Chemistry
  • Nucleoside Chemistry
  • Pyridine Chemistry
  • Suzuki Coupling & Reaction
  • Pyrimidine Chemistry
  • Swern Oxidation
  • Indole Chemistry
  • Sandmeyer Reaction
  • Grignard Reaction

In recent years, UNIT I has been accredited with certifications from global authorities:
- ISO 9001:2008

UNIT IV (CUSTOM SYNTHESIS DIVISION) - VAPI, GUJARAT

The facility has four manufacturing blocks aligned with more than 75 reactors (SS reactors, GLR reactors, hydrogenator) with a combined capacity of 329,000 litres. It is engaged in the manufacturing of intermediates required for the manufacture of Active Pharmaceutical Ingredients. Over 300 well-trained personnel operate the facility, ensuring adherence to quality systems and procedures.

The unit is capable of handling the following reactions:

  • Hydrogenation
  • Bromination
  • Chlorination
  • Condensation
  • Reduction
  • Oxidation
  • Sulfonation
  • Hydrolysis
  • Esterification
  • Friedel–Crafts alkylation, etc.

Capabilities:

  • To carry out hydrogenation up to 10 kg /cm2
  • Reaction temperature from -30°C to 200°C
Authority Date of Audit
USFDA Approved since June 2010
ISO ISO:9001:
Certified since 2011
Latest successful inspection in March 2016
OHSAS OHSAS:18001:-Certified since 2011
-Latest successful inspection in March 2016
AARTI INDUSTRIES LIMITED - UNIT III – TARAPUR, MAHARASHTRA

It specialises in the manufacture of Xanthine derivatives including Caffeine, Theophylline, Etofylline, and Aminophylline. The facility, with a workforce of over 100 employees, is aligned with SS reactors, GLR reactors, and PP reactors, with an API manufacturing capability of approximately 300 metric tonnes per month.

This unit is capable of handling the following reactions:

  • Nitrosation
  • Hydrogenation
  • Formylation
  • Cyclation
  • Methylation
  • Ethylation

Accreditations

  • cGMP
  • ISO 9001:2008
  • HACCP
  • HALAL
  • STAR KOSHER
  • FSSAI
  • EIA
AARTI INDUSTRIES LIMITED - UNIT IV – TARAPUR, MAHARASHTRA

It specialises in the manufacture of General APIs, Steroids and Anticancer APIs

Manufacturing Block No. – 1 : General API
Manufacturing Block No. – 2 : Steroids API (Dedicated)
Manufacturing Block No. – 3 : Anticancer API (Dedicated)
Manufacturing Block No. – 4 : General API

The blocks in the facility are aligned with more than 50 reactors (SS reactors, GLR reactors & PVDF reactors) with a combined capacity of 102,500L.

The facility has a workforce of over 300 dedicated employees.

The unit is capable of handling the following reactions:

  • Hydrogenation
  • Bromination
  • Condensation
  • Reduction
  • Oxidation
  • Methylation
  • Grignard
  • Sulfonation

Capabilities:

  • Reaction volume from 1 Kg output to 500 Kg output
  • Reaction temperature from -30°C to 200°C

Accreditations:

Authority Date of audit
USFDA Approved since June 2010
ISO APPROVED in March 2008
APPROVED in September 2011
APPROVED in March 2015
EU-GMP APPROVED by Danish Medicines Agency in April 2008
APPROVED by Freie und Hansestadt Hamburg May 2012
APPROVED by Freie und Hansestadt Hamburg in Aug 2013
APPROVED by Freie und Hansestadt, Hamburg in Jan 2015
ISO ISO 9001: 2000 certified since April 2006
Latest successful inspection in August 2015
WHO-GMP WHO GMP certified since Oct 2006
Latest successful inspection in Dec 2015
AARTI INDUSTRIES LIMITED - UNIT V – TARAPUR, MAHARASHTRA

It specialises in the manufacture of General API. The facility is aligned with SS reactors with a total capacity of 50,500L. A workforce of over 40 employees manages the facility.

The unit is capable of handling Methylation reaction.

Capabilities:

  • Reaction volume from 1 Kg output to 500 Kg output
  • Reaction temperature from -30°C to 200°C

AARTI INDUSTRIES LIMITED - UNIT V has been accredited with the below mentioned certifications from authorities around the globe.

Authority Address of Aarti Unit V
Mfg License (KD-769) Aarti Industries Limited- Unit No. V, Plot No. L-28/29, MIDC Tarapur, Dist: Thane.Pin-401506
GMP Aarti Industries Limited (732570), L-28 & L-29, MIDC Tarapur Plot No-L-28 & L-29 MIDC Tarapur- 401506, Tal. Palghar, Dist- Thane-Zone4
ISO 9001: 2008 Aarti Industries Limited- Unit V, Plot No.L-28/29, Tarapur MIDC Area, Dist. Palghar 401 506 Maharashtra, India.
ISO 22000: 2005 Aarti Industries Limited- Unit V, Plot No.L-28/29, Tarapur MIDC Area, Dist. Palghar 401 506 Maharashtra, India.
FSSC 22000 Aarti Industries Limited- Unit V, Plot No.L-28/29, Tarapur MIDC Area, Dist. Palghar 401 506 Maharashtra, India.
EU written Confirmation Aarti Industries Limited- Unit V, L-28/29,MIDC Tarapur, Dist. Thane-401506.
FSSAI Aarti Industries Limited- Unit No. V, L-28/29,MIDC,Tarapur Boisar-401506Dist. Thane,Thane (Maharashtra)-401506.
HACCP Aarti Industries Limited- Unit V, Plot No. L-28/29,MIDC,Tarapur, Tal- Palghar, Dist- Thane, Pin-401506, Maharashtra, India
HALAL Aarti Industries Limited- Unit V, Plot No. L-28/29,MIDC,Tarapur, Tal- Palghar, Dist- Thane, Pin-401506, Maharashtra, India
KOSHER Aarti Industries Limited- Unit V, Boisar, Maharashtra,India.
SMETA 4-pillar (Sedex) Aarti Industries Limited- Unit V, Plot No.: L-28/29, Tarapur MIDC. Tal- Palghar, Dist.-Thane. Maharashtra, India. Pin code – 401506.
AARTI INDUSTRIES LIMITED - R&D - DOMBIVALI, MAHARASHTRA

It specialises in the manufacture of Active Pharmaceutical Ingredients. The facility is aligned with R&D of Autoclave, Flow reactors, RBF and other equipment, with the capability of approximately 234 Li. A 40-member team mans the facility.

This unit is capable of handling the following reactions:

  • Asymmetric Hydrogenation
  • Darzens Glycidic Ester Condensation
  • Butyl Lithium Reaction
  • Hetero Diels Alder Reaction
  • Cyclopropane Chemistry
  • Purine Chemistry
  • Catalytic Hydrogenation
  • Pyrrole Chemistry
  • Nucleoside Chemistry
  • Pyrimidine Chemistry
  • Suzuki Coupling & Reaction
  • Pyrimidine Chemistry
  • Swern Oxidation
  • Indole Chemistry
  • Sandmeyer Reaction
  • Grignard Reaction

IN recent years the AARTI INDUSTRIES LIMITED - UNIT I has been accredited with the below mentioned certifications from authorities around the globe.

This unit is capable of handling the following reactions:

  • cGMP
  • ISO 9001:2008
  • WHO-GMP

Our Product

Our products, under the healthcare portfolio, have acquired a global reputation. To carry forward its strategy of forward integration, AIL has recently established a Custom Synthesis division. Presently, pharmaceutical intermediates are being manufactured in the Custom Synthesis plant in order to cater to the needs of various Indian and international customers.

The products are divided into 3 verticals:

  • API
  • Intermediates
  • Xanthine derivatives

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Our Services

The Contract Research and Manufacturing Services (CRAMS) is our fastest growing business segment in the healthcare division of Aarti Industries.

Aarti CRAMS is one of the leading cost-competitive and quality manufacturing hubs for many global players including big pharma companies. CRAMS basically consists of the following two activities

  • Contract research organisations(CROs) and
  • Contract manufacturing organisations(CMOs)

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