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    Company profile for North China Pharmaceutical Co., Ltd.

    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    EVENTS

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    About

    China Pharmaceutical Group is one of China's largest chemical and pharmaceutical companies, located in Shijiazhuang, capital of Hebei Province. North China Pharmaceutical Factory is the predecessor of China " fifteen " key construction project during the 1953 annual six months, started in 1958 in six months to put into operation, creating a history of large-scale production of antibiotics, to change the situation of underserve...
    China Pharmaceutical Group is one of China's largest chemical and pharmaceutical companies, located in Shijiazhuang, capital of Hebei Province. North China Pharmaceutical Factory is the predecessor of China " fifteen " key construction project during the 1953 annual six months, started in 1958 in six months to put into operation, creating a history of large-scale production of antibiotics, to change the situation of underserved do an important contribution. 1992 reorganization of the establishment of the North China Pharmaceutical Co., Ltd., 1994 years in the Shanghai Stock Exchange listing. 1996 years 1 month, North China Pharmaceutical formal restructuring of state-owned companies - a North China Pharmaceutical Group Co., Ltd., a complete end to the continuation of decades of the factory system. 2009 On 6 February, the Hebei government approval, Jizhong Energy Group, China Pharmaceutical Group implemented a restructuring, China Pharmaceutical Group to become the world 500 strong enterprises wholly owned subsidiary. Over the years, China Pharmaceutical Group continued innovation, sound management, and gradually expand the business scope continued to expand, maintain good development performance of major economic indicators will always be in the forefront of the industry. As of 2012 end, China Pharmaceutical Group total assets of 158 million yuan, employees 2 million people, with more than forty (minutes), the main products include antibiotics and semi-synthetic antibiotics, biotechnology drugs, biological pesticides and veterinary drugs, vitamins, nutrition and health product formulation 5 series 700 varieties. Put into operation a new cephalosporin, new formulation is representative of the new park projects, marking the opening of the China Pharmaceutical Group to build a leading world-class modern pharmaceutical group's new chapter.

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    North China Pharmaceutical Co., Ltd.China Flag
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    China
    Address
    Address
    No 388 East HePing Road Shijiazhuang City,HeiBei Provi Shijiazhuang, 050015
    Telephone
    Telephone
    +86-311-85993999
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    http://www.ncpc.com/
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

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    09 Nov 2024
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    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
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    https://www.pharmacompass.com/radio-compass-blog/medical-breakthroughs-in-2024-alzheimer-s-schizophrenia-copd-mash-see-pathbreaking-treatments

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    14 Nov 2024
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    NEWS #PharmaBuzz

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    GlaxoSmithKline Seeks U.S. Approval for Triple Lung Drug
    GlaxoSmithKline Seeks U.S. Approval for Triple Lung Drug

    22 Nov 2016

    // Ben Hirschler REUTERS

    http://www.reuters.com/article/us-gsk-respiratory-idUSKBN13G0MR

    Ben Hirschler REUTERS
    22 Nov 2016
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    North China Pharmaceutical Group Semisyntech Co., Ltd - STATEMENT OF NON-COMPLIANCE WITH GMP
    North China Pharmaceutical Group Semisyntech Co., Ltd - STATEMENT OF NON-COMPLIANCE WITH GMP

    31 Jan 2015

    // EUDRA GMDP

    https://www.pharmacompass.com/pdf/news/north-china-pharmaceutical-group-semisyntech-co-ltd-statement-of-non-compliance-with-gmp-1438773939.pdf

    EUDRA GMDP
    31 Jan 2015
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    ALL APIs

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    01

    Ampicillin Trihydrate

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

    The Pharmacy Technology
    Not Confirmed
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    Ampicillin Trihydrate

    China

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

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    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24713

    Submission : 2011-01-20

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-117 - Rev 00

    Issue Date : 2021-10-25

    Type : Chemical

    Substance Number : 168

    Status : Valid

     JDMF arrow-down
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    Registration Number : 219MF10142

    Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 052165, China

    Initial Date of Registration : 2007-04-27

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    02

    Cyclosporine

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

    The Pharmacy Technology
    Not Confirmed
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    Cyclosporine

    China

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

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    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33946

    Submission : 2019-06-15

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 305MF10032

    Registrant's Address : No. 8 Yangzi Road, Shijiazhuang, Economic & Technical Development Zone, Hebei 052160, China

    Initial Date of Registration : 2023-03-07

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    03

    Vitamin B12

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

    The Pharmacy Technology
    Not Confirmed
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    Vitamin B12

    China

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

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    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16906

    Submission : 2003-10-15

    Status : Inactive

    Type : II

     CEP/COS Inactive-api
    ✖

    Certificate Number : R1-CEP 2006-204 - Rev 00

    Issue Date : 2014-12-05

    Type : Chemical

    Substance Number : 547

    Status : Withdrawn by Holder

     JDMF arrow-down
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    Registration Number : 218MF10949

    Registrant's Address : No. 9,Zhaiying North Street, Shijiazhuang, Hebei,P. R. China

    Initial Date of Registration : 2006-11-24

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    04

    Amoxicillin Trihydrate

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

    The Pharmacy Technology
    Not Confirmed
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    Amoxicillin Trihydrate

    China

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

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    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26066

    Submission : 2012-05-15

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2014-220 - Rev 02

    Issue Date : 2023-09-05

    Type : Chemical

    Substance Number : 260

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Cyclosporine

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

    The Pharmacy Technology
    Not Confirmed
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    Cyclosporine

    China

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

    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10281

    Submission : 1993-06-08

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2021-399 - Rev 00

    Issue Date : 2024-02-20

    Type : Chemical

    Substance Number : 994

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 55500-0009

    Start Marketing Date : 2019-06-28

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Amphotericin B

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

    The Pharmacy Technology
    Not Confirmed
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    Amphotericin B

    China

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

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    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-12-16

    Pay. Date : 2021-09-29

    DMF Number : 18157

    Submission : 2005-03-10

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF arrow-down
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    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2023-06-08

    Registration Number : 20230608-210-J-1507

    Manufacturer Name : North China Pharmaceutical Huasheng Co., Ltd.

    Manufacturer Address : No.8 Yangzi Road, Shijiazhuang Economic & Technological Development Zone, Hebei 052160, China

     VMF Others AUDIT
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    07

    Bacitracin Zinc

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

    The Pharmacy Technology
    Not Confirmed
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    Bacitracin Zinc

    China

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

    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23358

    Submission : 2009-12-04

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Bacitracin Zinc

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

    The Pharmacy Technology
    Not Confirmed
    arrow

    Bacitracin Zinc

    China

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

    arrow
    The Pharmacy Technology
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-02-06

    Pay. Date : 2014-11-10

    DMF Number : 28615

    Submission : 2014-08-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Fidaxomicin

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

    The Pharmacy Technology
    Not Confirmed
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    Fidaxomicin

    China

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

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    The Pharmacy Technology
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-02-04

    Pay. Date : 2015-09-22

    DMF Number : 29374

    Submission : 2015-09-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Tacrolimus

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

    The Pharmacy Technology
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    Tacrolimus

    China

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

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    The Pharmacy Technology
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-04-02

    Pay. Date : 2021-03-19

    DMF Number : 34270

    Submission : 2020-03-25

    Status : Active

    Type : II

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

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    01

    Amoxicillin Trihydrate (non Sterile,...

    China
    PPS Boston
    Not Confirmed
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    02

    Amphotericin B Usp Non-sterile Bulk ...

    China
    PPS Boston
    Not Confirmed
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    03

    Ampicillin Trihydrate

    China
    PPS Boston
    Not Confirmed
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    04

    Bacitracin Usp

    China
    PPS Boston
    Not Confirmed
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    05

    Bacitracin Zinc Non-sterile Bulk Dru...

    China
    PPS Boston
    Not Confirmed
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    06

    Cyanocobalamin, Usp (vitamin B-12)

    China
    PPS Boston
    Not Confirmed
    arrow

    07

    Cyclosporine Usp, Non-sterile Bulk D...

    China
    PPS Boston
    Not Confirmed
    arrow

    08

    Cyclosporine, Usp (bulk, Non-sterile...

    China
    PPS Boston
    Not Confirmed
    arrow

    09

    Cyclosporine, Usp (non Sterile Bulk)

    China
    PPS Boston
    Not Confirmed
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    10

    Demeclocycline Hydrochloride

    China
    PPS Boston
    Not Confirmed
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    CEP/COS

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    01

    Amoxicillin trihydrate

    CEP/COS

    American Pharma Summit
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    02

    Amoxicillin trihydrate, Compacted

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    03

    Amoxicillin trihydrate, Enzymatic proces...

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    04

    Amoxicillin trihydrate, Enzymatic proces...

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    05

    Amphotericin B

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    06

    Ampicillin trihydrate

    CEP/COS

    American Pharma Summit
    Not Confirmed
    arrow

    07

    Ampicillin trihydrate, Enzymatic process

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    08

    Ascorbic acid

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    09

    Bacitracin

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    10

    Benzylpenicillin (procaine) monohydrate,...

    CEP/COS

    American Pharma Summit
    Not Confirmed
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    JDMF

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    01

    Ampicillin hydrate

    JDMF

    American Pharma Summit
    Not Confirmed
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    Ampicillin hydrate

    China
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    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Co., Ltd.

    Registration Number : 301MF10028

    Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...

    Initial Date of Registration : 2019-07-05

    Latest Date of Registration : 2019-07-05

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    02

    Ampicillin hydrate (production only)

    JDMF

    American Pharma Summit
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    Ampicillin hydrate (production only)

    China
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    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Co., Ltd.

    Registration Number : 219MF10142

    Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...

    Initial Date of Registration : 2007-04-27

    Latest Date of Registration : 2014-07-01

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    03

    Ampicillin sodium

    JDMF

    American Pharma Summit
    Not Confirmed
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    Ampicillin sodium

    China
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    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Co., Ltd.

    Registration Number : 226MF10211

    Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...

    Initial Date of Registration : 2014-11-17

    Latest Date of Registration : 2014-11-17

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    04

    Cyclosporine

    JDMF

    American Pharma Summit
    Not Confirmed
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    Cyclosporine

    China
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    American Pharma Summit
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    North China Pharmaceutical Huasheng Co Ltd

    Registration Number : 305MF10032

    Registrant's Address : No. 8 Yangzi Road, Shijiazhuang, Economic & Technical Development Zone, Hebei 052160,...

    Initial Date of Registration : 2023-03-07

    Latest Date of Registration : 2023-03-07

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    05

    Japanese Pharmacopoeia cyanocobalamin (p...

    JDMF

    American Pharma Summit
    Not Confirmed
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    Japanese Pharmacopoeia cyanocobalamin (p...

    China
    arrow
    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Huasheng Co Ltd

    Registration Number : 230MF10033

    Registrant's Address : Xingyuan Street, Biological Industry Zone, Nanbaishe Town, Zhao County, Shijiazhuang,...

    Initial Date of Registration : 2018-02-21

    Latest Date of Registration : 2018-02-21

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    06

    Japanese Pharmacopoeia cyanocobalamin (p...

    JDMF

    American Pharma Summit
    Not Confirmed
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    Japanese Pharmacopoeia cyanocobalamin (p...

    China
    arrow
    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Co., Ltd.

    Registration Number : 218MF10949

    Registrant's Address : No. 9,Zhaiying North Street, Shijiazhuang, Hebei,P. R. China

    Initial Date of Registration : 2006-11-24

    Latest Date of Registration : 2013-05-15

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    07

    Japanese Pharmacopoeia Mecobalamin (for ...

    JDMF

    American Pharma Summit
    Not Confirmed
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    Japanese Pharmacopoeia Mecobalamin (for ...

    China
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    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Huasheng Co Ltd

    Registration Number : 302MF10074

    Registrant's Address : Xingyuan Street, Biological Industry Zone, Nanbaishe Town, Zhao County, Shijiazhuang,...

    Initial Date of Registration : 2020-07-01

    Latest Date of Registration : 2020-07-01

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    08

    Piperacillin sodium

    JDMF

    American Pharma Summit
    Not Confirmed
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    Piperacillin sodium

    China
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    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Co., Ltd.

    Registration Number : 226MF10079

    Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...

    Initial Date of Registration : 2014-05-02

    Latest Date of Registration : 2014-05-02

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    09

    Sulbactam sodium

    JDMF

    American Pharma Summit
    Not Confirmed
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    Sulbactam sodium

    China
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    American Pharma Summit
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    North China Pharmaceutical Co., Ltd.

    Registration Number : 226MF10212

    Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...

    Initial Date of Registration : 2014-11-17

    Latest Date of Registration : 2014-11-17

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    10

    Sulbactam sodium

    JDMF

    American Pharma Summit
    Not Confirmed
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    Sulbactam sodium

    China
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    American Pharma Summit
    Not Confirmed
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    North China Pharmaceutical Co., Ltd.

    Registration Number : 230MF10001

    Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...

    Initial Date of Registration : 2018-01-10

    Latest Date of Registration : 2018-01-10

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    LISTED APIs

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    Ceftriaxone Sodium

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    North China Pharmaceutical Huasheng Co., Ltd is a joint venture invested by North China Pharmaceutical Co.Ltd. (NCPC), Hong Kong Newwin Financial Co., Ltd.and US Wincent Intl.Inc. Huasheng Co.was founded in 1995, it located in Shijiazhuang, Hebei Province, which is the "pharmaceutical capital"in China. Huasheng Co. is a professional manufactur...
    North China Pharmaceutical Huasheng Co., Ltd is a joint venture invested by North China Pharmaceutical Co.Ltd. (NCPC), Hong Kong Newwin Financial Co., Ltd.and US Wincent Intl.Inc. Huasheng Co.was founded in 1995, it located in Shijiazhuang, Hebei Province, which is the "pharmaceutical capital"in China. Huasheng Co. is a professional manufacturer and exporter specializing in pharmaceutical raw materials, the core products involved streptomycin sulfate, kasugamycin hydrochloride and dihydrostreptomycin sulfate, etc, Huasheng Co. is the largest production base of streptomycin sulfate in the world with annual output 1000 ton, our products enjoy high reputation and lead the competitive advantage at home and abroad. Huasheng Co. is equipped with top production facilities, all the workshops have been authenticated by National GMP in 2001, up-to-date processing methods and inspection techniques together with the high efficiency management guarantee the high quality of the products and professional services to our customers. All these make us your trustworthy partner. Huasheng Co. sincerely hopes to make cooperative partners with the friends all over the world on mutual benefits and common development.
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    01

    Ceftriaxone Sodium

    China
    euroPLX 86 Munich
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    Ceftriaxone Sodium

    China
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    North China Pharmaceutical Huasheng Co Ltd

    North China Pharmaceutical Huasheng Co., Ltd is a joint venture invested by North China Pharmaceutical Co.Ltd. (NCPC), Hong Kong Newwin Financial Co., Ltd.and US Wincent Intl.Inc. Huasheng Co.was founded in 1995, it located in Shijiazhuang, Hebei Province, which is the "pharmaceutical capital"in China. Huasheng Co. is a professional manufacturer and exporter specializing in pharmaceutical raw materials, the core products involved streptomycin sulfate, kasugamycin hydrochloride and dihydrostreptomycin sulfate, etc, Huasheng Co. is the largest production base of streptomycin sulfate in the world with annual output 1000 ton, our products enjoy high reputation and lead the competitive advantage at home and abroad. Huasheng Co. is equipped with top production facilities, all the workshops have been authenticated by National GMP in 2001, up-to-date processing methods and inspection techniques together with the high efficiency management guarantee the high quality of the products and professional services to our customers. All these make us your trustworthy partner. Huasheng Co. sincerely hopes to make cooperative partners with the friends all over the world on mutual benefits and common development.

    About the Company : North China Pharmaceutical Huasheng Co., Ltd is a joint venture invested by North China Pharmaceutical Co.Ltd. (NCPC), Hong Kong Newwin Financial Co., Ltd.and US Wincent Intl.Inc. Huasheng Co.w...

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    Inspections and registrations

    Upload your audits for free, ask us

    FDA

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    01

    FDA Audited

    USA
    The Pharmacy Technology
    Not Confirmed
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    FDA Audited

    USA
    arrow
    The Pharmacy Technology
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-11-11

    North China Pharmaceutical Huasheng Co Ltd

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-11-11

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    FDA Audited

    USA
    The Pharmacy Technology
    Not Confirmed
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    FDA Audited

    USA
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    The Pharmacy Technology
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-11-01

    North China Pharmaceutical Huasheng Co Ltd

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-11-01

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    03

    FDA Audited

    USA
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    FDA Audited

    USA
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    The Pharmacy Technology
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-28

    HEBEI WELCOME PHARMACEUTICAL CO., LTD.

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CFSAN

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

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-28

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    FDA Audited

    USA
    The Pharmacy Technology
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    FDA Audited

    USA
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    The Pharmacy Technology
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-28

    HEBEI WELCOME PHARMACEUTICAL CO., LTD.

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CFSAN

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

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-28

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    05

    FDA Audited

    USA
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    FDA Audited

    USA
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    The Pharmacy Technology
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-02

    North China Pharmaceutical Co., Ltd.

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-02

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    06

    FDA Audited

    USA
    The Pharmacy Technology
    Not Confirmed
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    FDA Audited

    USA
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    The Pharmacy Technology
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-05-31

    North China Pharmaceutical Co., Ltd.

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2013-05-31

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    07

    FDA Audited

    USA
    The Pharmacy Technology
    Not Confirmed
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    FDA Audited

    USA
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    The Pharmacy Technology
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-02

    North China Pharmaceutical Co., Ltd.

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-07-02

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    08

    FDA Audited

    USA
    The Pharmacy Technology
    Not Confirmed
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    FDA Audited

    USA
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    The Pharmacy Technology
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-05-31

    North China Pharmaceutical Co., Ltd.

    City : Shijiazhuang

    State :

    Country/Area : CN

    Zip :

    District : ORA

    Center : CVM

    Project Area : Monitoring of Marketed Animal Dr...

    District Decision : No Action Indicated

    Inspection End Date : 2013-05-31

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    ABOUT THIS PAGE

    Contact North China Pharmaceutical Co., Ltd and get a quotation

    North China Pharmaceutical Co., Ltd is a supplier offers 20 products (APIs, Excipients or Intermediates).

    Find a price of Ampicillin Trihydrate bulk with CEP, JDMF offered by North China Pharmaceutical Co., Ltd

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    Find a price of Cyclosporine bulk with CEP offered by North China Pharmaceutical Co., Ltd

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    Find a price of Bacitracin Zinc bulk with CEP offered by North China Pharmaceutical Co., Ltd

    Find a price of Ivermectin bulk with CEP offered by North China Pharmaceutical Co., Ltd

    Find a price of Piperacillin Sodium bulk with JDMF offered by North China Pharmaceutical Co., Ltd

    Find a price of Streptomycin bulk with CEP offered by North China Pharmaceutical Co., Ltd

    Find a price of Sulbactam Sodium bulk with JDMF offered by North China Pharmaceutical Co., Ltd

    Find a price of Tacrolimus bulk with CEP offered by North China Pharmaceutical Co., Ltd

    Find a price of Amoxicillin Trihydrate bulk offered by North China Pharmaceutical Co., Ltd

    Find a price of Ampicillin Trihydrate bulk offered by North China Pharmaceutical Co., Ltd

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    Find a price of Demeclocycline Hydrochloride bulk offered by North China Pharmaceutical Co., Ltd

    Find a price of Lincomycin Hydrochloride bulk offered by North China Pharmaceutical Co., Ltd

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