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Gland Chemicals Private Limited

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Gland Chemicals Private Limited

API Facility Aurangabad

Site acquired from Pfizer

Three major manufacturing sections

  1. Penicillins
  2. Carbapenems
  3. Multipurpose/multiproduct generic API’s

High containment and conventional GMP Active Pharmaceutical Ingredient (API) facility capable of manufacturing sterile carbapenems & non-sterile penicillins and small scale non-beta-lactam API’s.

Overview

  • Site is comprised of ~50 acres of land with 9 manufacturing blocks.
  • Historically the site was a global Carbapenem & Penicillin API supplier approved by US FDA (inspected 5 times), EDQM & MHRA (inspected 3 times), Danish Medical Agency, Korean (FDA), WHO GMP (inspected 3 times).
  • This facility has 170 reactors of varied construction features with over 580 KL of handling capacity together with several centrifuges, driers and production equipment.
  • Material handling systems, utility systems, dedicated in-process testing labs & process trouble shooting lab support the API manufacturing plants.
  • Historically the Facility supplied products to US, EU and ROW markets.

Areas

Name of the Product

Grade

Remarks

A

CARBAPENEMS

  

1

Meropenem Sterile for Injection

IP/USP

Available

B

PENICILLINS

  

1

Piperacillin + Tazobactam

IP/USP

Under Validation

2

Amoxicillin Trihydrate

IP/USP

Under Validation

Areas

Description

Batch scale (Kg)

Reactor
Range (Ltr)

In process lab

Reactors & Receivers

Distil-lation

Hydro
-genation

Cryogenics

Crystal-lization/ Filtration/ Isolation

Drying

Clean
Room

Penicillin
plants (I/II)

Dedicated self contained facility

100-375

1000-7000

Penem Intermediates
& API plant

Dedicated, self contained, Multi cubicle Plant

24-150

500-6000

Penem
Sterile Plant

High Containment, fully closed sterile API plant

50-100

100-3500

Other
APIs (I/II)

Flexible High Containment Small medium Scale multi product general purpose organic synthesis operations

4-150

1000-6000

Aurangabad API Plant