Metrochem API | Intermediate, API & Pellet Manufacturer

By PharmaCompass

2023-04-26

Impressions: 1986

View Metrochem API's portfolio of APIs, Intermediates & Pellets (Semi-finished formulations) & explore Metrochem's R&D activities on PharmaCompass.

Q1. What is Metrochem API and what are its product offerings?

Metrochem API is one of the fastest-growing Indian manufacturers of active pharmaceutical ingredients (APIs), pellets (semi-finished formulations) and intermediates. It provides customized volumes and quality products to its clients all over the world.

The company has six dedicated manufacturing facilities for its three core product groups - active pharmaceutical ingredients (APIs), pelletization and intermediates. These facilities, along with a well-equipped, centralized R&D laboratory, allow it to meet the high volume demands of its clients.

Metrochem API focuses on innovation across people, processes, products and technology through knowledge exchange and cross-functional collaboration. Its research center in Hyderabad has three fully functional laboratories along with an analytical laboratory. It provides custom research and custom synthesis services as well.

Metrochem API's six manufacturing facilities are located in Hyderabad and Visakhapatnam, India. These manufacturing facilities have received approval from several international regulatory agencies such as the USFDA, WHO GMP, Cofepris, KFDA and PMDA.

Metrochem API offers the following products:

APIs - Metrochem API is one of the leading active pharmaceutical ingredient (API) producers in India. It has its own R&D center and has received international FDA approval. It provides a variety of active pharmaceutical ingredients in multiple therapeutic areas, including antiulceratives, antifungals, antidepressants, antihypertensives, antithrombotic, antihistaminic, antilipemic, antiarthritic, anti-inflammatory, antidiabetic, antibacterial and gastoprokinetic.

Pellets - Metrochem API also offers pellets (semi-finished formulations) in multiple therapeutic areas, such as antiulceratives, anti-inflammatory, antihypertensive, antihyperlipidemic, antipsychotic, antiemetic, antithrombotic, antispasmodics, antiasthmatic, immunosuppressant, etc. It also offers blended, combination, taste-masking pellets and micro granules for direct compression.

Intermediates- Metrochem API makes various intermediates, including N-Benzylaniline, Pyridine-2-carbaldehyde, 1-bromo-4-chlorobenzene, 2-Hydroxymethyl-4-(3- methoxypropoxy)-3- methylpyridine, etc.

Q2. What R&D activities does Metrochem API focus on?

Metrochem API's R&D and manufacturing facilities in India have been constructed to meet the highest quality requirements. Metrochem's R&D center conducts research on APIs and intermediates that involve multi-step synthesis. The company has a proven track record of implementing and developing processes and scaling them up from the lab (kilo) to the commercial level.

Metrochem can create new products and meet the demands of life science companies all over the world because of its expertise in research, analytical technique development, synthesis of impurities, organic synthesis, multi-step synthesis, custom synthesis, scale-up and technology transfer.

The research center at Metrochem complies with cGLP standards and is focused on organic synthesis, custom synthesis services, analytical research, etc. The primary R&D activities of Metrochem API includes the development of active pharmaceutical ingredients (APIs), advanced intermediates and fine chemicals, with continuous process improvement for cost reduction and the long-term sustainability of its various businesses.

Metrochem API offers the technical know-how and cutting-edge equipment necessary to develop analytical techniques for assessing the quality of raw materials, advanced intermediates and finished products. With the use of sophisticated instruments like GC-MS/MS, multi nuclei NMR, preparative HPLC, HPLCs with detectors like UV, RI, and PDA, and GCs, it is capable of analyzing the impurity profiles and identifying degradation products in their active compounds.

The research center in Hyderabad contains three completely equipped laboratories and a well-equipped analytical laboratory spread across a 1,000 sq. meter area. Custom synthesis at Metrochem API is designed to satisfy the requirements of its customers, be they in the laboratory scale-up, commercial scale-up or post-commercialization stages. Metrochem API provides its extensive services along with a guarantee of quality and reliability. These are made available at a rate and cost that are beneficial to both parties.

Q3. Where are Metrochem's manufacturing sites located and what is their regulatory inspection history?

Metrochem API has emerged as one of India's fastest-growing pharmaceutical organizations. It has six cutting-edge production facilities situated in Hyderabad and Visakhapatnam, India. It has specialized manufacturing facilities for the production of APIs, pellets (semi-finished formulations) & intermediates, which are supported by a well-equipped, centralized research & development laboratory.

Metrochem's manufacturing facilities have been approved by several international regulatory bodies such as ISO 9001-2015, USFDA, WHO GMP, Cofepris, as well as PMDA. The facilities have also been inspected by KFDA.

The details about some of Metrochem's production units are as follows:

Unit I for APIs - It is a dedicated facility located in Hyderabad, India, specializing in the production of active pharmaceutical ingredients (APIs). The facility has ISO 9001:2015, PMDA, WHO GMP and local GMP certification.

The site spans across an area of 1006.25 sq. meters and comprises 10 reactors with a total volume of 30 KL. The facility also includes Class 100000 areas, consisting of 176.00 sq. meters for pharma grade manufacturing and 5.55 sq. meters for sampling and dispensing.

Unit II for Pellets - The facility is located in Hyderabad, India, and is a dedicated site for the production of pellets (Semi-finished formulations). The facility has ISO 9001:2015, WHO-GMP and local GMP certification.

The site spans an area of 1300.00 square meters and has a total of 13 FBC reactors with a capacity of 6,020 Kgs FBCV. Additionally, there are two Class 100000 areas within the facility., covering a manufacturing area of 634.00 sq. meters, while the sampling & dispensing area covers 8.43 sq. meters.

Unit B for Intermediates - This facility is located in Sangareddy, India, and is solely devoted to the production of advanced Intermediates. The facility has received an accreditation of ISO 9001:2015.

The site is spread over approximately 6.0 acres and has four reactors, including five GLRS and 35 SSRs, with a total volume capacity of 130 KL. The facility also has one class 100000 area.

Unit C for Intermediates - This facility is also situated in Sangareddy, India, and is dedicated to the production of intermediates. The facility has received accreditations from ISO 9001:2015 and USFDA.

The site is spread across an area of 26,040 sq. meters and houses 58 reactors (G-14 and SSR-44), with a total volume capacity of 237.101 KL. The facility also includes Class 100000 areas, including a sampling & dispensing area covering 2.86 sq. meters.

Unit IV for APIs & Intermediates - Situated in Visakhapatnam, India, this facility is dedicated to the production of APIs & intermediates. It has ISO 9001:2015 and Schedule-M GMP certifications.

The site occupies a total area of 386.50 meters and has 129 reactors with a total volume capacity of 715.53 KL. The facility also includes 11 Class 100000 areas, including the manufacturing area and sampling & dispensing area.

Q4. What is Metrochem API's approach to environmental sustainability, and how does the company demonstrate its commitment to environmental management?

Metrochem API is a responsible manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates that recognises and values environmental management as one of its top corporate priorities. It operates all aspects of its business as a responsible steward of the environment.

According to Metrochem, environmental management must incorporate the principles and practices for protecting the environment, decreasing pollution and conserving natural resources. It believes companies should comply with the relevant laws and regulations and should be committed towards continual improvement.

Metrochem API is committed to environmental sustainability and has made it one of its top corporate priorities. The company adheres to relevant laws and regulations and continuously strives for improvement.

Metrochem API has established a framework for setting environmental objectives and targets, which are implemented, documented and communicated to all personnel in the organization. Additionally, Metrochem makes its environmental policy available to the public.

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : Biosynthesis, tech advancements by PharmaCompass license under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

BLOG

MARKET INTEL by PharmaCompass

CONTENT by Suppliers

News

Q1. What is Metrochem API and what are its product offerings?

Q2. What R&D activities does Metrochem API focus on?

Q3. Where are Metrochem's manufacturing sites located and what is their regulatory inspection history?

Q4. What is Metrochem API's approach to environmental sustainability, and how does the company demonstrate its commitment to environmental management?