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GMP SERVICES

We offer various GMP services which can help clients across the globe, ranging from audits to various consulting services. We provide the following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

AUDITS

  • The success of any clinical trial/BABE project depends on assuring that the data collected are of good quality. A well organize system audit will point out potential problem areas early so that the solutions can be found before it is too late. This can be ensured by various types of audits.
  • Due to the increasing complexity of clinical trials and regulatory scrutiny, the components of a site audit program and the approaches taken towards designing and managing audits are constantly evolving. Pharmazone Auditors has extensive experience in their respective subject matter to accomplish the objective of the audit.

Audits Reports

Aastrid Life Sciences Pvt Ltd.
India
Maharashtra
India
A-Solution Pharmaceuticals Pvt. Ltd.
Maharashtra
India
Aarti Drugs Ltd
Maharashtra
India
Acharya Chemicals
Maharashtra
India
Actis Generics Private Limited
Visakhapatnam
India
Ace bright Pharma Ltd
Bengaluru
India
Aether Industries Limited
Gujarat
India
Aju Pharm
Gyeonggi-do
Korea
Alembic Pharmaceuticals Limited (Unit I)
Halol
India
Alembic Pharmaceuticals Limited (Unit II)
Halol
India
Alfresha fine chemical corporation
Japan
ALG chemicals
Raigad
India
Alexanderwerk GmbH
Remscheid
Germany
Almelo Pvt. Ltd. Unit II
Telangana
India
Ambio Shanghai
Shanghai
China
Ami Organics
Surat
India
Amoli Organics
Vadodara
India
Amoli Organics
Vapi
India
Amcor Flexibles Kreuzlingen AG
Kreuzlingen
Switzerland
Amsal Chem Pvt Ltd
Gujarat
India
Andhra Organics Ltd
Andhra Pradesh
India
Andhra Sugars Ltd
Andhra Pradesh
India
Anhui Haikang Pharmaceutical Co.
Ltd.
Daguan
China
Angs Chemie
Germany
Anguo Shengshan Pharmaceutical
Anguo
China
Anquing Chico Pharmaceutical
Anhui
China
Anhui Haihua Chemical
Anhui Province
China
Apothecon Pharmaceuticals Pvt. Ltd.
Gujarat
India
Aptar Group Inc.
Jiangsu
China
Aragen-GVK biosciences private ltd
Telangana
India
Arene Lifesciences
Telangana
India
Artemis Biotech
Hyderabad
India
Ascent Finochem Pvt Ltd.
Ahmedabad
India
Aspen Oss B.V.
Boxtel
Netherlands
Aurisco Pharmaceutical Co.
Ltd
Zhejiang Province
China
Auro Labs Ltd
Thane
India
Aurobindo Pharma Unit I
Hatnora Mandal
India
Aurobindo Pharma Unit III
Polepally
India
Aurobindo Pharma Unit VII
Bachupally
India
Aurobindo Pharma Unit VIII
Gaddapotharam
India
Aurobindo Pharma Unit XI
Andhra Pradesh
India
Aurobindo Pharma UNIT-V Ltd
Telangana
India
Aurore Pharmaceuticals Pvt. Limited
Hyderabad
India
Avik Pharmaceutical Limited
Gujarat
India
Azico Biophore
Vishakhapatnam
India
Alembic Pharmaceuticals Limited (Unit III)
Gujarat
India
D.K. Pharmachem Pvt Ltd
Badlapure
India
Bal Pharma
Bangalore Karmataka
India
Baotou Dongbao Bio-Tech Co.
Ltd
Baotou City
China
BDR Pharma
Vadodara
India
Benzo Chem Industrues Private Limited
Maharastra
India
Bhagat Aromatics Ltd.
Nodia
India
Biocon Limited Site I
Bangalore
India
Biocon Limited Site 2
Bangalore
India
Biocon Site V
Andhra Pradesh
India
Biophore India Pharmaceuticals Private Limited
Vishakhapatnam
India
Brightgene Pharmaceuticals
Suzhou
China
BMI Korea
Jeju-do
Republic of Korea
Bushu Pharmaceuticals Limited
Saitama
Japan
Cadchem Laboratories
Sahibzada Ajit Singh Nagar
India
Cadila Pharma
Bharuch
India
Cadila Healthcare Ltd.
Vadodara
India
Caltron Clays & Chemicals Pvt. Ltd
Maharashtra
India
Cangzhou Senary Chemical
Cangzhou
China
Caplin Steriles Limited
Tamil Nadu
India
Cdymax (India) Pharma Private Limited
Karnataka
INDIA
Centaur Pharmaceuticals
Thane
India
Chromo Laboratories India Pvt. Ltd
Telangana
India
Changzhou Sunlight Pharmaceutical Co. Ltd.
Changzhou
China
Changzhou Pharmaceutical
Changzhou
China
Chemische Fabrik Berg GmbH
Bitterfeld-Wolfen
Germany
Chemo Biosynthesis s.r.l.
Corana
ITALY
Church and Dwight Co
Old Fort
USA
Cipla Unit VII
Goa
India
Cipla
Kurkumbh
India
Cipla
Pune
India
Cipla
Banglore
India
Cipla
Maharashtra
India
Changzhou SynTheAll Pharmaceutical
Jiangsu
China
Chromo Laboratories India Pvt. Ltd
Telangana
India
Coral Drug limited
Haryana
India
Corden Pharma Ltd
Chenove
France
Corvine Chemicals and Pharmaceuticals
Hyderabad
India
Corey Organics
Andhra Pradesh
India
Crystal Pharma
Valladolid
Spain
CSPC Ouyi
Hebei
China
Curia Italy S.r.l.
Lodi
Italy
Danopharm Chemicals Pvt. Ltd.
Bharuch
India
Dasami Lab Private Limited
Telangana
India
Delta Finochem
Maharashtra State
India
Divis Laboratories Limited (Unit- II)
Andhra Pradesh
India
Dr. Reddy's Lab Unit VI
Srikakulam
India
Dr. Reddy's Lab Unit VII
Bollaram
India
Dr. Reddy’s Labs CTO Unit I
Telanagana
India
Dr. Reddy’s Labs CTO Unit II
Telanagana
India
Dr. Reddy’s Labs CTO Unit V
Telangana
India
Dr. Reddy’s Lab CTO Unit VI
Andhra Pradesh
India
Drug Plastics Closures Inc.
Phoenix
USA
Drug Plastics & Glass Co. Inc.
Valley City USA
Embio Ltd.
Maharashtra
India
Emmennar Pharma
Andhra Pradesh
India
Enantiotech Corporation Ltd
Guangdong Province
China
Endoc lifecare Private Limited
Gujarat
India
Eriochem S.A.
República Argentina
Eurofins Bel/Novamann s.r.o
Bratislava
Slovakia
Eurofins Bel/Novamann s.r.o
Piestany
Slovakia
Eurofins (Proxy) Laboratories
Leiden
Netherlands
Euticals SAS
Bon Encontre
France
Everlight Pharmaceuticals
Taoyuan city
Taiwan
Excel Industries Limited Division Pharma
Parshuram State
Maharashtra
Enaltec
Thane
India
FarmaBios
Cairoli
Italy
Farmak JSC
Kyiv Region
Ukraine
Farmak Ltd
Olomouc
Czech Republic
Farmenta Biotech Ltd.
Gujarat
India
Fabbrica Italiana Sintetici
Vicenza
Italy
FDC Limited
Maharashtra
India
Fermion Oulu plant
Oulu
Finland
Finoso
Hyderabad
India
FIS
Vicenza
Italy
Fleming Laboratories Limited
Telangana
India
Flexistuff International LTD
Madhya Pradesh
India
Formosa Lab Inc
Taoyuan
Taiwan
Fuji Chemicals
Toyama
Japan
Gland Pharma
Vishakhapatnam
India
Gerresheimer Vaerloese A/S
Vaerloese
Denmark
Glenmark Lifesciences
Bharuch
India
Glenmark Lifesciences Ltd
Gujarat
India
Glochem
Telangana
India
GMT
Couvet
Switzerland
Granules India
Hyderabad
India
Granules India
Andhra Pradesh
India
Grindeks
Riga
Latvia
Guan Peking
Langfang
China
Guangdong Raffles Pharma Tech Co. Ltd.
Guangdong
China
Guju Pharma
Gyeonggi-do
South Korea
GVK Bioscience
Mallapur
India
Haian Meiya Pharmaceutical Co.
Ltd.
Jiangsu
China
Hangzhou Zhongmei Huadong Pharmaceutical
Zhejiang
China
Harman Finochem
Chikalthana
India
HEC Pharma
Hubei Province
China
Hebei Jiheng Pharmaceuticals
Hengshui
China
Hetero Drugs Unit I
Bonthapally
India
Hetero Lab Unit I
Telangana
India
Hetero Labs Unit III
Andhra Pradesh
India
Hetero Drugs Unit IX
Andhra Pradesh
India
Hikal Ltd
Bangalore
India
Honour Lab Limited Unit-III (Formerly Hetero Labs Ltd.)
Visakhapatnam
India
Honour Lab Limited Unit-V
Telangana
India
Hubei Honch Pharma
Hubei
China
Ihsedu Argrochem
Jagana Palanpur
India
Indo Amines Ltd.
Maharashtra
India
Ind-Swift Laboratories Limited
Punjab
India
Industiale Quimica
Saronno
Italy
Intech Biopharm Limited
Hsinchu
Taiwan
Interquim S.A.
Barcelona
Spain
Intas
Ahmedabad
India
IPCA
Madhya Pradesh
India
IOL Chemicals & Pharmaceuticals
Punjab
India
Jacobi Carbons France SASU
Vierzon
France
Jay Overseas
Bharuch
Gujarat
Jiangxi Dongbang
Fengxin
China
Jilin Shengtong
Jilin
China
Jiangxi Synergy Pharmaceutical Co. Ltd
Jiangxi
China
Jiangxi Tianxin Pharmaceutical
Jiangxi
China
Jiangsu Hengrui Medicine Co.Ltd.
Jiangsu
China
Jiangsu Xidi Pharmaceuticals Co.
Ltd.
Qidong City
China
Jiangyin TSI Pharmaceutical Co.
Ltd.
Jiangsu
China
Joyang Laboratories
Yancheng
China
JRC Corporation
Vadodara
India
JW Life Sciences
Chungcheongnam
South Korea
Jubilant Generics
Nanjangud
India
Kedar Janani Chemplast
Thane
India
Keshava Organics Pvt Ltd
Maharastra
India
Kopran Research Laboratories Limited
Maharashtra
India
KOWA Co. Ltd
Tochigi
Japan
Laurus Bio Pvt. Ltd.
Karnataka
India
Lee Pharma Limited
Telangana
India
Lupin Limited
Gujarat
India
Laurus Labs
Visakhapatnam
India
Log Plastics
Ihud
Israel
Luohe Chief Pharmaceuticals Co. Ltd
Henan Province
China
Lysi HF
Reykjavik
Iceland
Maithri Drugs
Bonthapally
India
Maithri Laboratories
Gaddapotharam
India
Mangalam Drugs and Organics
Gujarat
India
Maps Laboratories Pvt. Ltd.
Gujarat
India
Maithri Drugs Pvt. Ltd.
Telangana
India
Mangalam Drugs and Organics
Gujarat
India
Maithri Laboratories Pvt. Ltd.
Telangana
India
Megafine Pharma
Nashik
India
Megafine Pharma
Maharashtra
India
Mega Lifesciences Public Ltd.
Thailand
Melody Healthcare
Maharashtra
India
Micro Labs
Bangalore
India
Millennium Chemi Pharm
Karnataka
India
Morepen Laboratories Ltd.
Solan
India
MSN Laboratories
Rudram
India
MSN Lifesciences
Chandampet
India
MSN Pharmchem
Pashamylaram
India
Mylan Laboratories Limited
Andhra Pradesh
India
Naari Pharma Private Limited
Nainital
Uttarakhand
Nakoda Chemcicals
Telangana
India
Nantong Chanyoo Pharmatech
Nantong
China
Natco Pharma
Chennai
India
Natco Pharma
Telangana
India
Natco Pharma Limited
Telangana
India
Neuland Laboratories Unit - I
Telangana
India
Neuland Laboratories Unit - II
Telangana
India
Neuland Laboratories Unit - III
Telangana
India
Newchem
Verona
Italy
Northern Synthesis
Riga
Latvia
Nosch Labs Pvt. Ltd
Hyderabad
India
Novaprint
S. de R.L de C.V.
Ciudad de México
México
Nifty Labs Pvt. Ltd
Andhra Pradesh
India
Opocrin S.p.A.
Formigine
Italy
Optimus Drugs Ltd
Telangana
India
Orchid Healthcare (Bionpharma)
Tamil Nadu
India
Penmix Factory
Chungcheongnam
South Korea
Piramal
Digwal
India
Piramal
Chennai
India
Pharmathen S.A.
Attiki
Greece
PMC Isochem
Gennevilliers
France
PMC Isochem
Pithiviers
France
Pregna International Limited
Daman and Diu
Praveen Laboratories
Gujarat
India
Polpharma
Pomorskie
Poland
Polymed Therapeutics
Zhejiang Province
China
Polynt SPA
Cavaglià BI
Italy
Precise Chemipharma
Maharashtra
India
Prudence Pharma Chem
Gujarat
India
QPS Holdings LLC
North Dakota
USA
RA Chem Pharma
Andhra Pradesh
India
RA Chem Pharma
Telangana
India
Ratnamani Bio Chemicals & Pharmaceuticals Pvt. Ltd.
Gujarat
India
Riddhi pharma
Gujarat
India
Sanofi Chimie
Gentilly
France
Saurav Chemicals Limited (Unit III)
Punjab
India
Shanghai Desano
Shanghai
China
Shanghai Ethypharm Pharmaceutical Co. Ltd
Shangha
China.
Shanghai Medicilon Inc.
Shanghai
China
Shandong New Time Pharma
Shandong
China
Shandong Xinhua Pharmaceutical co Ltd
Shandong Province
Cj
Shilpa Medicare
Raichur
India
Shilpa Medicare
Shaktinagar
India
Shriji Polymers
Ujjain
India
Shree Jee Laboratories Pvt. Ltd
Rajasthan
India
Shashi Phytochemical Industries
Rajasthan
India
Shandong New Time Pharmaceutical Co.
Ltd.
Shandong Province
China
Sichuan Xieli Pharmaceutical Co.
Ltd.
Sichuan Province
China
Sicor Societa Italiana Corticosteroidi S.r.l
Santhia
Italy
Sinopharm Weiqida
Datong Shanxi
China
Simcere Pharmaceutical Co.
Ltd.
Jiangsu Province
China
Sionc Pharma
Andhra Pradesh
India
Sirio Healthcare
Anhui
China
SMS Pharmaceuticals Unit-I
Kazipalli
India
SNA Healthcare
Maharashtra
India
Solara Active Pharma Sciences Ltd.
Pondicherry
India
Solara Active Pharm Sciences Ltd.
Cuddalore
India
State Vererinary Institute
Czech Republic
Sterile-gene Lifesciences Private Limited.
Pondicherry
India
Stellar Chemical Laboratories Private Limited
Gujarat
India
Strides Pharma Science Ltd
Pondicherry
India
Steile Gene Lifesciences
Pondicherry
India
Sun Pharmaceuticals
Gujarat
India
Strides Pharma Science Ltd
Punducherry
India
Sterling spa Italia
Corciano PG
Italy
Sterling Chemical Malta Ltd.
Corciano PG
Italy
Sun Bio Inc
Gyeonggi-do
South Korea
Sun Pharmaceuticals
Maharashtra
India
Sun Pharmaceuticals
Tamil Nadu
India
Sun Pharmaceutical Industries Limited
Punjab
India
Suven Life Sciences
Hyderabad
India
Symbiotec Pharmalab
Pithampur
India
Symed Laboratories Unit I
Domadugu
India
Symed Laboratories Limited Unit II
Telangana
India
Symed Laboratories Limited Unit IV
Telangana
India
Synthokem Lab Unit - I
Telangana
India
Synthokem Lab Unit - II
Telangana
India
Synthokem Labs Unit – III
Viskhapatnam
India
Taizhou Xianju Pharmaceutical Co.
Ltd.
Zhejiang
China
Teva API India Private Ltd.
Uttar Pradesh
India
Teva API India Private Limited
Uttar Pradesh
India
Teva Pharmaceuticals
Sheva
Israel
The United Laboratories co ltd
inner Mongolia
China
Taizhou Xianju
Linhai
China
Tianjin Tianyao Pharmaceuticals
Tianjin city
China
Tianjin Zhongrui
Tianjin City
China
Transpek Industry Limited
Gujarat
India
Torrent Pharmaceuticals Ltd.
Mehsana
Gujarat
TSI Group
Jiangsu
China
USV Private Limited
Ratnagiri
India
Vaasavaa Pharmaceuticals
Maharashtra
India
Vasudha Pharmchem Unit I
Jeedimetla
India
Vasudha Pharmchem Unit II
Vishakhapatnam
India
Vasudha Pharmchem Unit III
Vishakhapatnam
India
Vindhya Organics
Sangareddy
India
Vision Drugs-Unit 2
Godavari Dist
India
Veer-Chemie & Aromatics
Telangana
India
Wanbury Ltd.
Andra Pradesh
India
Yancheng Kaili Pharmaceutical Co. Ltd
Yangcheng City
China
YungZip Chemical
Taichung
Taiwan
Yangzhou Aurisco Pharmaceutical Co. Ltd
Yangzhou city
China
ZCL Chemicals
Bharuch
India
Zhejiang Ausun Pharmaceutical
Zhejiang
China
Zhejiang Chiral Medicine Chemicals Co.
Ltd.
Zhejiang
China
Zhejiang Changming Pharma
Zhejiang
China
Zhejiang Haisen
Zhejiang Province
China
Zhejiang Huahai Pharmaceuticals
Linhai
China
Zhejiang Jiuzhou Pharma
Taizhou
China
Zhejiang Jiangbei Pharmaceuticals
Taizhou
China
Zhejiang Jiuzhou Pharmaceuticals Ltd.
Zhejiang
China
Zhejiang Raybow Pharmaceutical Co. Ltd.
Taizhou
China
Zhuhai Rundu Pharmaceutical
Zhuhai City
China
Zhejiang Tianyu Pharmaceutical
Taizhou City
China
Zhejiang Wild Wind Pharmaceutical Co.
Ltd.
Dongyang City
China

Compliance and Upgradation

We provide GMP Upgradation services in compliance with guidelines USFDA, EMA, WHO, PICS.

We provide an integrated solution for GMP Compliance & Upgradation tailored to your needs at low costs in a time-efficient manner by:

 

  • Establishing GMP Management Systems
  • Performing the Gap Analysis
  • Planning Activity as per Guidelines
  • Guidance in Implementation & Documentation
  • Training Activities for Executives
  • Conducting Internal Audits

Engineering

We offer the engineering services to cover complete range from Conceptualization till Validation.
Conceptual Engineering

Identify the technical and economic feasibility of the Plant Set – Up project by conducting feasibility as per GMP guidelines, to develop basic and detailed engineering.

Basic Engineering

We provide one or two solutions that emerge as the most suitable in the previous phase with design details including field studies, especially of a topographical, geological, geotechnical, hydrological and hydraulic nature.

Detailed Engineering

We provide all the construction details by discipline (Civil, Mechanical, Process, Electric, Telecommunications, Instrumentation and Control, Computer Systems) which is needed /must be approved for construction.

Procurement

We assist in the procurement of all types of Equipment, Utilities, Change Parts & Clean Room Panels etc. as per URS/BOQ/ Tender Documents

Commissioning & Qualification

We offer services for GMP-compliant Commissioning & Qualification of all equipment, Utilities & facilities as well as Validation to ensure reproducible Processes for Production, Cleaning, Analytic Methods and Computer Systems.

Validation

We serve all your validation requirements from project management to report writing that is from URS, FRS, DQ, FAT, SAT, Commissioning documents, VMP, IQ, OQ, PQ, PV to Validation report writing.

GMP Consulting

We cover different pieces of entire product management cycle as customized services.

Pharma Plant Set-Up: We have extensive experience in setting up the complete pharmaceutical manufacturing units which include IV fluids, Injectable, Tablet, Capsule, Liquid orals, Liquid externals, Powders, Bulk drugs, Liquid oral plants, Ointment/ Cream/ Lotions manufacturing plants.

 

QP Services: Include services like Product Release, Permanent / Short Term QP Cover, Quality System Review & Implementation, Risk Management, Supplier Assessment Review & Management, API / Formulation QP Audits & Certification

 

Sourcing: We help in procurement of the best quality of Raw Materials, Packing Materials & Finished Goods through our experience at competitive prices from established manufacturers /trading houses.

 

Training: Our qualified & experienced Trainers provide training on all GXP topics  GMP, GDP, GLP, Data Integrity, Regulatory Affairs, QMS, Auditor Qualification and many other topics which enhance your employees and operational performance while mitigating compliance and business risks.  Training agendas for each topic are customized based on experience of participants.

 

Regulatory: Our Regulatory experts provide CTD/eCTD Dossier Compilation & Submission, User Testing & Medical Writing services.

 

Contract Manufacturing: The emergence of India as a world player in Pharmaceuticals has brought foreign companies the opportunity to outsource part of their production to Indian manufacturers, thus cutting costs & production hassles. We consult companies, both Indian and foreign on their contracting requirements.

 

Business & Marketing: Providing businesses at all stages with expert consultancy on how to strategically position & promote themselves,  their products and services in order to tap into new markets, attract new customers, increase sales and ultimately increase profit.